Inspections, Compliance, Enforcement, and Criminal Investigations

FY2011 Inspectional Observation Summaries

Number of 483s issued from the System*

Inspections ending between 10/1/2010 12:00 AM and 9/30/2011 12:00 AM

Center Name	483s issued
Foods	3827
Devices	1035
Drugs	758
Incidental text	422
Bioresearch monitoring	297
Veterinary medicine	289
Biologics	258
Parts 1240 and 1250	146
Human tissue for transplantation	109
Radiological health	24
Special requirements	22
Sum Product Area 483s from System*	7187
Actual Total in system 483s**	6547

* This table does not represent the complete set of 483s issued during the fiscal year as some 483s were manually prepared and not available in this format. The sum of 483s for all Product Areas will be greater than the actual Total 483s issued during the fiscal year since a 483 may include citations related to multiple product areas, and counted more than once, under each relevant product center.

** This is the Actual Total number of 483s issued from this system, and that are represented in this spreadsheet.

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Foods

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Foods	1560	21 CFR 110.35(c)	670	Lack of effective pest exclusion	Effective measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the premises by pests]. Specifically, ***
	1524	21 CFR 123.11(b)	488	Sanitation monitoring	You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
	1306	21 CFR 110.20(b)(7)	448	Screening	Failure to provide adequate screening or other protection against pests. Specifically, ***
	1422	21 CFR 110.20(b)(4)	354	Floors, walls and ceilings	The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good repair]. Specifically, ***
	1552	21 CFR 110.35(a)	335	Buildings/sanitary	Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
	905	21 CFR 123.6(b)	316	HACCP plan implementation	You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, ***
	1287	21 CFR 110.20(a)(1)	294	Harborage areas	Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures. Specifically, ***
	1553	21 CFR 110.35(a)	287	Buildings/good repair	Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, ***
	1695	21 CFR 110.80(b)(2)	259	Manufacturing conditions	Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination]. Specifically, ***
	1405	21 CFR 110.10(b)(6)	243	Failure to wear	Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, ***
	2386	21 CFR 110.80(a)(1)	242	Storage	Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, ***
	990	21 CFR 110.10(b)(3)	240	Not washed/sanitized when appropriate	Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before starting work] [after each absence from the work station] [at any time their hands may have become soiled or contaminated]. Specifically, ***
	1701	21 CFR 110.80(b)(7)	240	Equipment, containers, utensils	Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination. Specifically, ***
	904	21 CFR 123.6(b)	236	No HACCP plan	You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur. Specifically, ***
	1554	21 CFR 110.35(a)	232	Cleaning and sanitizing operations	Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
	1525	21 CFR 123.11(c)	229	Sanitation Records	You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation deficiencies] for [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
	6004	21 CFR 123.6(c)(4)	223	Monitoring - adequacy	Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically***
	963	21 CFR 123.6(c)(5)	222	Corrective action plan	Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected]. Specifically***
	959	21 CFR 123.6(c)(1)	216	Food safety hazards	Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
	1427	21 CFR 110.20(b)(5)	215	Safety lighting and glass	Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, ***
	1424	21 CFR 110.20(b)(4)	208	Drip and condensate	The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
	960	21 CFR 123.6(c)(2)	207	Critical control points	Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards. Specifically, ***
	961	21 CFR 123.6(c)(3)	207	Critical limits	Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical limit that does not ensure control of one or more hazards]. Specifically,
	1689	21 CFR 110.80	204	Reasonable precautions	All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
	1007	21 CFR 110.10(b)(9)	186	Precautions against contamination--micro, foreign substances	Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
	1562	21 CFR 110.35(d)	177	Failure to clean - general	Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, ***
	6008	21 CFR 123.8(a)(3)	170	Verification - record review - frequency	You did not review [some of] your [critical control point monitoring][corrective action][calibration][in-process testing][end-product testing] records [within one week][within a reasonable time] after the records were made. Specifically, ***
	908	21 CFR 123.6(d)	164	Signed and dated	Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, ***
	2392	21 CFR 110.80(b)(1)	164	Maintenance of equip., utensils, and finished food packaging	Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing. Specifically, ***
	945	21 CFR 123.12(a)(2)	163	Importer verification	You do not have or have not implemented [written verification procedures] [product specifications] [an affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with the Seafood HACCP regulation. Specifically, ***
	1556	21 CFR 110.35(b)(2)	158	Storage requirements	Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide chemicals] in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
	1292	21 CFR 110.20(b)(1)	153	Sufficient space	Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for the maintenance of sanitary operations and the production of safe food. Specifically, ***
	1581	21 CFR 110.37(e)	153	Running water at suitable temperature	Hand-washing facilities lack running water of a suitable temperature. Specifically, ***
	1597	21 CFR 110.37(b)(3)	146	As source of contamination	Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, ***
	1005	21 CFR 110.10(b)(7)	141	Storage of personal items	Personal [clothing] [belongings] were storedin an area where [food is exposed] [equipment or utensils are washed]. Specifically, ***
	6020	21 CFR 123.9(a)	137	Records - content	Your records do not include the [name and location of the processor or importer] [date and time of the activity the record reflects] [signature or initials of the person performing the operation] [identity of the product and the production code, if any]. Specifically, ***
	1125	21 CFR 110.40(a)	134	Materials and workmanship	The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, ***
	1698	21 CFR 110.80(b)(5)	129	Work-in-progress	Failure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
	1402	21 CFR 110.10(b)(4)	127	Unsecured jewelry	Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, ***
	1615	21 CFR 110.93	124	Storage/transportation of finished goods (contamination)	Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination. Specifically, ***
	3652	21 CFR 110.37(e)(1)	122	Suitable locations	Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, ***
	3659	21 CFR 110.37(e)(3)	120	Hand drying	Lack of a sanitary towel service or suitable hand drying devices. Specifically, ***
	1006	21 CFR 110.10(b)(8)	117	Personal food/drink/tobacco	Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in areas where [food is exposed] [equipment or utensils are washed]. Specifically, ***
	1406	21 CFR 110.10(b)(6)	108	Effective use of hair restraint	Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, ***
	6001	21 CFR 123.11(b)	108	Sanitation monitoring documentation	Your sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically***
	6021	21 CFR 123.10	106	HACCP training or qualification	No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, ***
	985	21 CFR 110.10(b)(1)	105	Suitable outer garments	Suitable outer garments are not wornthat protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
	4470	21 CFR 108.25(c)(2)	103	Process filing	Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, ***
	3661	21 CFR 110.37(e)(5)	100	Signs	Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, ***
	933	21 CFR 123.8(a)(2)(ii)	99	Calibration - adequacy	Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
	3658	21 CFR 110.37(e)(2)	96	Hand cleaning and sanitizing preparations	Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
	1173	21 CFR 110.40(f)	94	Q.C. instrument accuracy, maintenance	Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not [accurate] [adequately maintained]. Specifically,***
	1702	21 CFR 110.80(b)(8)	92	Metal / extraneous materials	Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, ***
	12720	21 CFR 1.225	90	Not registered	Your food facility is not registered as required. Specifically, ***
	1066	21 CFR 110.40(b)	89	Seams on food contact surfaces	Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of microorganisms. Specifically, ***
	6005	21 CFR 123.6(c)(6)	89	Verification procedures - adequacy	Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented. Specifically, ***
	1126	21 CFR 110.40(a)	88	Precluding contaminants	The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
	1571	21 CFR 110.35(d)(5)	83	Shown to be effective	The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
	1429	21 CFR 110.20(b)(6)	81	Fans/air blowing equipment	Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential for contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
	1426	21 CFR 110.20(b)(5)	77	Adequate lighting	Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms] [areas where food is examined, stored, or processed] [areas where equipment and utensils are cleaned]. Specifically, ***
	1599	21 CFR 110.37(b)(5)	76	Backflow prevention	Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
	1172	21 CFR 110.40(e)	71	Lack of thermometer	Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms. Specifically, ***
	6018	21 CFR 123.7(a)	70	Corrective action per predetermined plan	You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically,***
	1067	21 CFR 110.40(c)	66	Non food-contact equipment in processing area	Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition. Specifically, ***
1578	21 CFR 110.37(f)	66	Odor, attractant for pests, harborage	The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor] [potential for waste becoming an attractant and harborage or breeding place for pests]. Specifically, ***
3086	21 CFR 114.100(b)	66	Maintenance of processing and production records	Failure to maintain [processing] [production] records showing adherence to the scheduled processes, including records of [pH measurement] [critical factors] intended to ensure a safe product. Specifically, ***
9931	21 CFR 120.6(b)	65	Sanitation monitoring	You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good manufacturing practice including [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
901	21 CFR 123.6(a)	62	Hazard analysis	You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process. Specifically, ***
1293	21 CFR 110.20(b)(2)	61	Contamination with microorganisms, chemicals, filth, etc.	Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from contamination with [microorganisms] [chemicals] [filth] [extraneous material] cannot be taken because of deficiencies in plant [size] [construction] [design]. Specifically, ***
6015	21 CFR 123.6(c)(6)	61	Verification procedures - none/frequency	Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented. Specifically, ***
3654	21 CFR 110.37(d)(1)	60	Maintained	Failure to maintain toilet facilities in a sanitary condition. Specifically, ***
1565	21 CFR 110.35(d)(3)	59	Non-food-contact surfaces (S)	Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, ***
1570	21 CFR 110.35(d)(5)	57	Safe and adequate for use	Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
1598	21 CFR 110.37(b)(4)	51	Drainage	Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, ***
1709	21 CFR 110.80(b)(13)	50	Filling, assembling, packing controls	Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, ***
3080	21 CFR 114.83	50	Scheduled process establishment	A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods. Specifically, ***
3643	21 CFR 110.10(b)(5)	50	Glove condition	Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, ***
3656	21 CFR 110.37(d)(3)	49	Self-closing doors	Toilet facilities lack self-closing doors. Specifically, ***
3647	21 CFR 110.10(c)	48	Training of handlers and supervisors	Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors]. Specifically, ***
1128	21 CFR 110.40(a)	47	Installation and maintenance of equipment (S)	Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, ***
1132	21 CFR 110.40(a)	47	Food-contact - unlawful indirect additives	Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives. Specifically, ***
1763	21 CFR 110.35(b)(1)	47	Safe and adequate for use	Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the conditions of use]. Specifically, ***
1596	21 CFR 110.37(b)(2)	45	Convey sewage	Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant. Specifically, ***
906	21 CFR 123.6(b)	44	HACCP plan location	Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed]. Specifically, ***
1602	21 CFR 110.37(a)	44	Suitable temp. and pressure	Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of food] [cleaning of equipment, utensils and food-packaging materials] [employee sanitary facilities]. Specifically, ***
2388	21 CFR 110.80(a)(5)	44	Holding in bulk or suitable containers	Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination. Specifically, ***
6019	21 CFR 123.8(a)(2)	44	Ongoing verification - complaints, calibration records	Your verification procedures do not include, at a minimum, ongoing verification activities including [review of consumer complaints] [calibration of process monitoring instruments] [review of monitoring, corrective action, and calibration records]. Specifically, ***
4464	21 CFR 108.25(c)(1)	42	Registration	Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of acidified foods. Specifically, ***
931	21 CFR 123.8(d)	41	Verification - recordkeeping	You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
1696	21 CFR 110.80(b)(3)	41	Holding foods - refrigerate/freeze/heat	Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. Specifically, ***
1403	21 CFR 110.10(b)(4)	40	Hand jewelry - remove/cover	Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand. Specifically, ***
3078	21 CFR 114.80(b)	40	Code - required elements	Each container is not marked with an identifying code specifying the [establishment where the product was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
6007	21 CFR 123.9(a)	39	Records entries - timing	Processing or other information was not [always] entered on your records at the time it was observed. Specifically, ***
3657	21 CFR 110.37(d)(4)	37	Doors opening into processing areas	Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination. Specifically, ***
15927	21 CFR 111.103	36	Written procedures - quality control operations	You did not [establish] [follow] written procedures for quality control operations. Specifically, ***
3655	21 CFR 110.37(d)(2)	35	Good repair	Failure to keep toilet facilities in good repair. Specifically, ***
15797	21 CFR 111.553	34	Written procedures - product complaint	You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint. Specifically, ***
3085	21 CFR 114.100(a)	33	Raw materials, packaging, finished product	Records are not maintained of the examination of [raw materials] [packaging materials] [finished products] [supplier's guarantees or certificates] to verify compliance with FDA regulations and guidelines or action levels. Specifically, ***
16135	21 CFR 118.4(b)(4)	33	Stray animals	Stray animals are not prevented from entering poultry houses. Specifically,***
1289	21 CFR 110.20(a)(3)	32	Drainage	Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place for pests]. Specifically, ***
3073	21 CFR 114.80(a)(2)	32	pH testing	Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher than 4.6. Specifically, ***
6006	21 CFR 123.6(c)(7)	32	Records values/observations	Your monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, ***
6010	21 CFR 123.8(a)(3)(i)	32	Monitoring record review adequacy	Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that are within critical limits]. Specifically, ***
913	21 CFR 123.8(a)(1)	31	Reassessment of HACCP plan	Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least annually] [whenever modifications to the process are made]. Specifically, ***
4479	21 CFR 108.25(e)	31	Recall procedures	Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining the effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
15839	21 CFR 111.70(e)	31	Specifications - identity, purity, strength, composition	You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement. Specifically, ***
16203	21 CFR 118.10(b)(1)	31	Name and location	All required records do not include [your name] [the location of your farm]. Specifically,***
15532	21 CFR 111.255(b)	30	Batch record - complete	Your batch production record did not include complete information relating to the production and control of each batch. Specifically, ***
918	21 CFR 123.8(a)	29	Verification - reviewers qualifications	The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions. Specifically, ***
3067	21 CFR 114.80(a)	29	Quality control procedures	Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "***
15861	21 CFR 111.75(a)(2)(ii)(A)	29	Component - qualify supplier	You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations. Specifically, ***
3071	21 CFR 114.80(a)(1)	28	Scheduled process	Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***
16118	21 CFR 118.4	28	Written SE plan not implemented/followed	Your written SE prevention plan is not [fully] implemented and followed. Specifically,***
16142	21 CFR 118.4(c)(3)	28	Removal of pest harborages	Potential harborages for pests in and outside your poultry house have not been eliminated by [removing debris within a poultry house] [removing debris and vegetation outside the poultry house]. Specifically,***
16204	21 CFR 118.10(b)(2)	28	Date and time of activity	All your required records do not include the [date] [time] of the activity that the records reflect. Specifically,***
1129	21 CFR 110.40(a)	27	Food-contact - corrosion resistant	Lack of corrosion-resistant food contact surfaces. Specifically, ***
2361	21 CFR 110.80	27	Testing	Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
3712	21 CFR 110.93	27	Storage/transportation of finished goods (deterioration)	Failure to [store] [transport] finished food under conditions that would protect against deterioration of the food and its container. Specifically, ***
4475	21 CFR 108.25(c)(3)(i)	27	Process adherence	Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
15858	21 CFR 111.75(a)(1)(i)	27	Component -verify identity, dietary ingredient	You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use. Specifically, ***
16193	21 CFR 118.10(a)(3)(ii)	27	Rodent and pest control documentation	You did not maintain records documenting compliance with rodent and other pest control measures. Specifically,***
6016	21 CFR 123.6(c)(7)	26	Records system	Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, ***
1130	21 CFR 110.40(a)	25	Food-contact - withstand food & cleaning cmpds.	Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand the action of food] [withstand cleaning compounds and sanitizing agents]. Specifically, ***
4181	21 CFR 113.89	25	Process deviation identification	Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control. Specifically, ***
1425	21 CFR 110.20(b)(4)	24	Spacing of equipment	Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, ***
1184	21 CFR 110.35(e)	23	Storage of cleaned portable equipment (S)	Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-contact surfaces from contamination. Specifically, ***
1561	21 CFR 110.35(c)	23	Insecticides/rodenticides	Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
1697	21 CFR 110.80(b)(4)	23	Preventive control measures	Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control] [water activity control] to destroy or prevent the growth of undesirable microorganisms in food. Specifically, ***
4511	21 CFR 108.25(f)	23	Approved school	Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
16120	21 CFR 118.4	23	Written SE plan lacks required elements	Your written SE prevention plan lacks appropriate SE prevention measures. Specifically,***
16205	21 CFR 118.10(b)(3)	23	Signatures or initials on operational records	All required records do not have the signature or initials of the person performing the operation or creating the record. Specifically,***
1642	21 CFR 113.100(b)	22	Review not signed/dated	Failure of the reviewer to [sign or initial] [date] the [processing records] [production records] [recording temperature chart(s)] after the completion of the processing of a low-acid food product. Specifically, ***
2385	21 CFR 110.80(a)(1)	22	Inspection, segregation, handling of raw materials	Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food. Specifically, ***
3660	21 CFR 110.37(e)(4)	22	Devices and fixtures	Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, ***
932	21 CFR 123.7(d)	21	Corrective action documentation	You do not have records that document corrective actions that were taken. Specifically, ***
3075	21 CFR 114.80(a)(4)	21	Container testing	Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination. Specifically, ***
12742	21 CFR 120.8(a)	21	HACCP plan not implemented	You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, ***
950	21 CFR 123.12(d)	20	Determination of compliance	You have not provided evidence that the [fish] [fishery products] you import have been processed under conditions that comply with the Seafood HACCP regulation. Specifically, ***
986	21 CFR 110.10(b)(2)	20	Personal cleanliness	Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness. Specifically, ***
1090	21 CFR 110.40(d)	20	Holding, conveying, mfg systems - design & construction	Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition. Specifically, ***
1316	21 CFR 113.87(c)	20	Initial temperature	The initial temperature of the contents of a container to be processed was [not determined] [not recorded] with sufficient frequency to ensure the temperature was not lower than the minimum initial temperature stated in the scheduled process. Specifically, ***
2394	21 CFR 110.80(b)(6)	20	Contamination by raw materials, refuse, other ingredients	Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] . Specifically, ***
6009	21 CFR 123.8(a)(3)(iii)	20	Verification - record review - calibration	You did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, ***
16117	21 CFR 118.4	20	No written SE prevention plan	Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you produce eggs. Specifically,***
975	21 CFR 123.9(b)(1)	19	Record retention	Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically, ***
2393	21 CFR 110.80(b)(1)	19	Teardown equipment/thorough cleaning	Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***
3062	21 CFR 114.10	19	Personnel	Operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
9930	21 CFR 120.6(c)	19	SSOP records	You do not [always] maintain sanitation standard operating procedure records that document [the monitoring of conditions and practices during processing] [corrections to conditions and practices that were not met]. Specifically, ***
12721	21 CFR 1.234	19	Registration not updated	You did not submit an update to your facility's registration within 60 calendar days of [a change] [changes] to the registration information previously submitted. Specifically, ***
15763	21 CFR 111.205(a)	19	Master manufacturing record - unique formulation	You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured. Specifically, ***
16195	21 CFR 118.10(a)(3)(iv)	19	Refrigeration requirements documentation	You do not maintain records documenting compliance with refrigeration requirements. Specifically***
1766	21 CFR 110.35(b)(1)	18	Unacceptable toxic compounds	Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations. Specifically, ***
3090	21 CFR 114.100(d)	18	Product distribution	Records identifying initial distribution of finished product are not maintained. Specifically, ***
6014	21 CFR 123.6(c)(2)	18	Monitoring - none	Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance with the critical limit. Specifically,
12734	21 CFR 120.12(a)	18	Records required - not maintained	You do not maintain [complete] records documenting [the implementation of your sanitation standard operating procedure] [your written HACCP plan] [your written hazard analysis] [monitoring of critical control points and their critical limits] [corrective actions taken in response to a deviation] [the verification of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard analysis]. Specifically, ***
15641	21 CFR 111.453	18	Written procedures - holding	You did not [establish] [follow written] procedures for holding and distributing operations. Specifically, ***
2384	21 CFR 110.80(a)(7)	17	Receipt/storage - liquid and dry raw materials	Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination. Specifically, ***
4519	21 CFR 108.35(c)(3)(i)	17	Process adherence	Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
15531	21 CFR 111.255(a)	17	Batch record - every batch	You did not prepare a batch production record every time you manufactured a batch of dietary supplement. Specifically, ***
15830	21 CFR 111.70(b)(2)	17	Specifications-component purity, strength, composition	You did not establish component specifications for [purity] [strength] [composition]. Specifically, ***
16152	21 CFR 118.5(a)	17	Testing when laying hens 40 to 45 weeks	Environmental testing for SE, using approved methods,was not done in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,***
1601	21 CFR 110.37(a)	16	Safe and adequate sanitary quality	Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, ***
9955	21 CFR 120.11(a)(1)	16	Verification activities - minimum	Your verification activities do not include, at a minimum, [review of consumer complaints to determine whether they relate to the performance of the HACCP plan] [calibration of process monitoring instruments] [end-product or in-product testing] [review of critical control point monitoring, corrective action, and calibration records] to ensure that your HACCP system is being properly implemented. Specifically, ***
15498	21 CFR 111.27(d)	16	Equipment - maintain, clean, sanitize	You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
15762	21 CFR 111.205(a)	16	Master manufacturing record - each batch	You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary supplement that you manufactured. Specifically, ***
15809	21 CFR 111.570(b)(1)	16	Written procedures - product complaint; review, investigate	You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint. Specifically, ***
16042	21 CFR 111.503	16	Written procedures - returned dietary supplement	You did not [establish] [follow] written procedures for when a returned dietary supplement is received. Specifically, ***
1529	21 CFR 113.89	15	Process deviation log/file	Process deviations were not recorded in a separate file or log that details both the deviations and the actions taken. Specifically, ***
2396	21 CFR 110.80(b)(6)	15	Conveyor transportation	Failure to take effective measures to protect food transported by conveyor from contamination. Specifically, ***
4529	21 CFR 108.35(c)(2)(ii)	15	Process change reporting to CFSAN	For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, within 30 days after first use, [a complete description of the modifications made and utilized] [a copy of the file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process]. Specifically, ***
9932	21 CFR 120.6(a)	15	Sanitation SSOP - none or not implemented	You do not [always] have or have not implemented a sanitation standard operating procedure that addresses sanitation conditions and practices before, during and after processing. Specifically, ***
9935	21 CFR 120.7(a)	15	No hazard analysis	You did not develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for [each type of]juice you produce. Specifically, ***
9941	21 CFR 120.8(a)	15	No HACCP plan	You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur. Specifically, ***
9958	21 CFR 120.12(c)	15	Records - signed/dated	Your [written hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were] not signed and dated [upon initial acceptance] [upon modification] [upon verification] [upon validation] [by the most responsible individual onsite at the processing facility or by a higher level official]. Specifically, ***
15869	21 CFR 111.75(c)	15	Specifications met - verify; finished batch	You did not verify that your finished batch of dietary supplement meets product specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]. Specifically, ***
16122	21 CFR 118.4(a)(2)(i)	15	Pullet environment testing	Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,***
929	21 CFR 123.8(b)	14	Verification - corrective action	You did not take immediate corrective action to ensure that [no affected product entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed] when your verification procedure revealed the need to take a corrective action. Specifically, ***
1330	21 CFR 113.100(a)	14	Processing entry missing information	Forms used to record processing or production information lack the [product] [code number] [date] [retort or processing system number] [container size] [approximate number of containers per coding interval] [initial temperature] [actual processing time] [mercury-in-glass thermometer readings] [recording thermometer readings] [appropriate processing data]. Specifically, ***
1577	21 CFR 110.37(f)	14	Contamination of food, contact surfaces, water supplies, etc	The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces]. Specifically, ***
1711	21 CFR 110.80(b)(15)	14	Proper pH controls	Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the control of pH to prevent the growth of undesirable microorganisms. Specifically, ***
6017	21 CFR 123.7(c)	14	Corrective action per regulation	You did not take corrective action that ensured [the affected product was segregated] [a review of the affected product was done to determine its acceptability] [affected product was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation and modified as necessary]. Specifically, ***
12747	21 CFR 120.8(b)(3)	14	HACCP plan - critical limits not listed or not adequate	Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control point] [lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food hazard]. Specifically, ***
15659	21 CFR 111.475(b)(1)	14	Written procedures - holding; distributing	You did not make and keep written procedures for holding and distributing operations. Specifically, ***
15736	21 CFR 111.353	14	Manufacturing operations - written procedures	Youdid not [establish] [follow] written procedures for manufacturing operations. Specifically, ***
16206	21 CFR 118.10(b)(3)	14	Signature and date on SE plans	Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s) who administer the plan]. Specifically,***
1734	21 CFR 113.40(a)(2)	13	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2427	21 CFR 110.80(b)(9)	13	Proper disposal of adulterated product	Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food. Specifically, ***
9947	21 CFR 120.11(b)	13	HACCP plan - not validated	You did not validate that your HACCP plan is adequate to control food hazards [at least once within 12 months after implementation] [at least annually] [when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way]. Specifically, ***
9954	21 CFR 120.11(a)(1)(iv)	13	Verification - CCP, CA record review	You did not review [all of] your [critical control point monitoring] [corrective action] records within one week (7 days) of the day the records are made. Specifically, ***
12746	21 CFR 120.8(b)(2)	13	HACCP plan - critical control points not listed	Your HACCP plan does not list the critical control points for each of the identified food hazards. Specifically, ***
15494	21 CFR 111.25(c)	13	Procedures - equipment - cleaning, sanitizing	Youdid not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing,equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
15819	21 CFR 111.55	13	Production, process controls - implement	You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement. Specifically, ***
15828	21 CFR 111.70(a)	13	Specifications - manufacturing process	You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is packaged and labeled as specified in the master manufacturing record]. Specifically, ***
16140	21 CFR 118.4(c)(2)	13	Monitoring for flies	The presence of flies is not monitored by appropriate monitoring methods. Specifically,***
3662	21 CFR 110.37(e)(6)	12	Refuse receptacles	Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, ***
6022	21 CFR 123.12(c)	12	Lack of records	You do not have records to document the performance and results of the affirmative steps taken to demonstrate that [fish] [fishery products] imported into the United States were processed in accordance with the seafood HACCP regulation. Specifically, ***
12755	21 CFR 120.11(a)(1)(iv)	12	Records - not signed and dated by qualified individual	Your review of [critical control point monitoring records] [corrective action records] [calibration records] [periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience. Specifically, ***
15401	21 CFR 111.12(b)	12	Personnel - quality control operations	You have not identified personnel to be responsible for your quality control operations. Specifically, ***
15829	21 CFR 111.70(b)(1)	12	Specifications - component identity	You did not establish an identity specification for each component. Specifically, ***
15897	21 CFR 111.83(a)	12	Reserve sample - collect, hold	You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed. Specifically, ***
16139	21 CFR 118.4(c)(1)	12	Satisfactory rodent control methods	When your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods were not used to achieve satisfactory rodent control. Specifically,***
16149	21 CFR 118.4(e)	12	Egg transport temperature/time	Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay. Specifically,***
1196	21 CFR 110.10(a)	11	Employees with illness,lesions, contamination source	Employeeswho appear to have an [illness] [open lesion] [abnormal source of microbial contamination] are not excluded from operations where there is a reasonable possibility of [food] [food contact surfaces] [food packaging materials] becoming contaminated. Specifically, ***
1641	21 CFR 113.100(b)	11	Review not done/timely	A review of processing and production records by a qualified representative of plant management was not done [within one working day after the completion ofthe process] [before shipment or release for distribution] to determine [completeness of the records] [whether product was processed as specified by the scheduled process]. Specifically, ***
2389	21 CFR 110.80(a)(5)	11	Identify rework	Failure to identify material scheduled for rework as such. Specifically, ***
2391	21 CFR 110.80(a)(6)	11	Thawed appropriately	Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, ***
4515	21 CFR 108.35(c)(2)	11	Process filing	Failure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each container. Specifically, ***
9939	21 CFR 120.7(c)	11	All hazards not considered	In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the evaluation for you] did not consider [microbiological contamination] [parasites] [chemical contamination] [unlawful pesticide residues] [decomposition] [natural toxins] [use of unapproved color or food additives] [presence of undeclared ingredients that may be allergens] [physical hazards]. Specifically, ***
12743	21 CFR 120.8(b)(4)	11	HACCP plan - monitoring procedures not adequate	Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits. Specifically, ***
12745	21 CFR 120.8(b)(1)	11	HACCP plan - food hazards not listed	Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
15496	21 CFR 111.27(b)	11	Instruments - calibration	You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine intervals or as necessary] to ensure the accuracy and precision of the instruments or controls. Specifically, ***
15786	21 CFR 111.410(b)	11	Labels - issuance, use	You did not control the [issuance] [use] of labels, Specifically, ***
16183	21 CFR 118.9	11	Supervisor(s) training/job experience	Supervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job experience to administer the SE prevention measures]. Specifically,***
1045	21 CFR 113.10	10	Supervisors	Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility. Specifically, ***
1060	21 CFR 123.11(a)	10	SSOP(S)	You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, ***
1566	21 CFR 110.35(d)(4)	10	Single-service articles	Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects against the contamination of food and food-contact surfaces. Specifically, ***
2887	21 CFR 113.40(j)	10	Conform to requirements	The system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers [did not conform to the applicable requirements of 21 CFR 113.40] [did not conform to methods and controls specified in the scheduled process] [were not operated and administered in a manner that ensures commercial sterility is achieved]. Specifically, ***
3645	21 CFR 110.10(d)	10	Supervision	Responsibility for assuring compliance with current good manufacturing practices relating to personnelhas not been assigned to competent supervisory personnel. Specifically, ***
4296	21 CFR 110.80(a)(5)	10	Temperature and humidity	Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated. Specifically, ***
6002	21 CFR 123.11(b)	10	Sanitation corrections	You did not correct sanitation deficiencies in a timely manner. Specifically,***
15410	21 CFR 111.14(b)(2)	10	Personnel - records - training	You did not make and keep documentation of training. Specifically, ***
15790	21 CFR 111.403	10	Written procedures - labeling operations	You did not [establish] [follow] written procedures for labeling operations. Specifically, ***
16070	21 CFR 111.35(b)(2)	10	Document-equipment date of use, maintain, clean, sanitize	You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of the equipment. Specifically, ***
1255	21 CFR 129.20(a)	9	Bottling room separation	The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination. Specifically, ***
1568	21 CFR 110.35(d)(2)	9	Before use and after interruption	Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been contaminated], to preclude contamination with microorganisms. Specifically, ***
1639	21 CFR 113.100(b)	9	Entries not timely	Entries on [processing records] [production records] were not made at the time the specific retort or processing system condition or operation occurred. Specifically, ***
1670	21 CFR 110.80(a)(4)	9	Safety assurance - pests/extraneous materials	There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels. Specifically, ***
2101	21 CFR 113.40(a)(13)	9	Measured, recorded	Critical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors are within limits specifiedin the scheduled process. Specifically, ***
2886	21 CFR 113.40(i)	9	Inadequate instruments	The time and temperature of processing and other critical factors specified in the scheduled process were not measured with instruments having adequate accuracy or dependability. Specifically, ***
3088	21 CFR 114.100(b)	9	Processing and production - required information	The [processing] [production] records do not contain sufficient additional information such as [product code] [date] [container size] [product] to permit a public health hazard evaluation of the processes applied to each [lot] [batch] [portion] of production. Specifically, ***
3877	21 CFR 113.60(c)	9	Coding - required elements	The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed][period during which packed]. Specifically, ***
9919	21 CFR 120.10(a)	9	Corrective action - predetermined plan inadequate	You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, ***
15404	21 CFR 111.12(c)	9	Personnel - education, training, experience	Personnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have the education, training, or experience to perform the person's assigned functions. Specifically, ***
15543	21 CFR 111.260(c)	9	Batch record - date, time; maintenance	Your batch production records did not include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained. Specifically, ***
16089	FDCA 417(d)(1)(A)	9	Reportable food report - submission	You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food. Specifically, ***
16138	21 CFR 118.4(c)(1)	9	Monitoring for rodents	The presence of rodents is not monitored by appropriate monitoring methods. Specifically,***
16192	21 CFR 118.10(a)(3)(1)	9	Biosecurity measures documentation	You did not maintain records documenting compliance with biosecurity measures. Specifically,***
938	21 CFR 123.9(c)	8	Official review	You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations. Specifically, ***
1471	21 CFR 113.83	8	Scheduled processes not established	Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing. Specifically, ***
1500	21 CFR 113.89	8	Evaluation by process authority	Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority. Specifically, ***
1669	21 CFR 110.80(a)(3)	8	Aflatoxin and other natural toxins	There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food. Specifically, ***
1708	21 CFR 110.80(b)(12)	8	Batters, breading, gravies, sauces, etc.	Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in a manner that protects against [contamination] [growth of microorganisms]. Specifically, ***
3650	21 CFR 110.35(d)(1)	8	Wet cleaning	Failure to sanitize and thoroughly dry, prior to use,food-contact surfaces which have been wet cleaned. Specifically, ***
3651	21 CFR 110.37(b)(5)	8	Cross contamination	Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, ***
3709	21 CFR 110.80(a)(1)	8	Inspection of containers and carriers upon receipt	Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does not contribute to the contamination or deterioration of food. Specifically, ***
4476	21 CFR 108.25(c)(3)(ii)	8	Process information availability	Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, ***
15302	21 CFR 120.11(a)(2)	8	Calibration, testing - no records	You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
15453	21 CFR 111.16	8	Written procedures - cleaning	You did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, ***
15492	21 CFR 111.25(a)	8	Procedures - calibrating instruments	You did not [establish] [follow] written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. Specifically, ***
15747	21 CFR 111.210(g)	8	Packaging description, representative label	Your master manufacturing record did not include a [description of the packaging] [a representative label, or a cross-reference to the physical location of the actual or representative label]. Specifically,
15796	21 CFR 111.430(b)	8	Records - packaging, labeling operations	You did not make and keep records of the written procedures for [packaging] [labeling] operations. Specifically, ***
15838	21 CFR 111.70(d)	8	Specifications - labels, packaging	You did not establish [label] [packaging] specifications. Specifically, ***
15853	21 CFR 111.73	8	Specifications met - identity, purity, strength, composition	You did not determine whether you met established product specifications for [identity] [purity] [strength] [composition of the finished batch of the dietary supplement]. Specifically, ***
15885	21 CFR 111.77(a)	8	Specifications not met - reject, quality control	Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for which a specification was not met. Specifically, ***
16179	21 CFR 118.8(a)	8	Method to be used, environmental samples	For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE. Specifically,***
1040	21 CFR 113.10	7	Operators	Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems] are not under the operating supervision of a person that has attendedand satisfactorily completed, a school approved by the Commissioner. Specifically, ***
1483	21 CFR 113.87(a)	7	Operating processes not posted	Operating processes for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators]. Specifically, ***
1595	21 CFR 110.37(b)(1)	7	Sufficient quantities of water	Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required locations throughout the plant. Specifically, ***
2274	21 CFR 129.80(g)(1)	7	Bacteriological	You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
3072	21 CFR 114.80(a)(1)	7	Thermal processing	Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of growing in the food. Specifically, ***
3089	21 CFR 114.100(c)	7	Process deviations- identification and records	Departures from a scheduled process having a possible bearing on public health or the safety of a food are not [noted] [identified] [recorded] [made the subject of a separate file (or log identifying the appropriate data) delineating them]. Specifically, ***
3653	21 CFR 110.37(d)	7	Readily accessible	Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
3663	21 CFR 110.40(e)	7	Lack of automatic control / alarm (S)	Lack of [an automatic control for regulatingtemperature] [an automatic temperature alarm system] for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms. Specifically, ***
9928	21 CFR 120.12(b)	7	Records - general - include name, date, time	Your required records do not [always] include [the name of the processor] [the name of the importer] [the location of the processor] [the location of the importer] [the date and time of the activity] [the signature or initials of the person performing the operation or creating the record] [the identity of the product] [the production code]. Specifically, ***
12749	21 CFR 120.8(b)(6)	7	HACCP plan - verify procedures / frequency - none listed	Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented. Specifically, ***
15402	21 CFR 111.12	7	Personnel - quality control personnel - qualified	The personnel you identified to perform quality control operations [are not qualified to do so] [do not have the education, training or experience to perform the assigned functions]. Specifically, ***
15570	21 CFR 111.153	7	Written procedures - components	You did not [establish] [follow] written procedures for the requirements for components of dietary supplements. Specifically, ***
15623	21 CFR 111.180(b)(2)	7	Records - receiving; components, packaging, labels, products	You did not make and keep receiving records for [components] [packaging] [labels] [products you received for packaging or labeling as a dietary supplement]. Specifically,***
15737	21 CFR 111.210(h)(5)	7	Corrective action plans	The written instructions in yourmaster manufacturing did not include instructions for corrective action plans to use when specifications are not met. Specifically, ***
15761	21 CFR 111.205(b)(1)	7	Master manufacturing record - specifications; quality	Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
15800	21 CFR 111.560(a)(2)	7	Product complaint - quality control investigate	A qualified person did not investigate a product complaint that involved a possible failure of a dietary supplement to meet a specification, or other requirement. Specifically, ***
15817	21 CFR 111.570(b)(2)(ii)(F)	7	Record - product complaint; findings	The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken]. Specifically, ***
15928	21 CFR 111.103	7	Written procedure quality control operations material review	You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision. Specifically, ***
16040	21 CFR 111.610(a)	7	Records - available; FDA	You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested. Specifically, ***
16134	21 CFR 118.4(b)(3)	7	Cross contamination from people	You do not maintain practices that will protect against cross contamination when people move between poultry houses. Specifically,***
16207	21 CFR 118.10(b)(4)	7	Data and information re: compliance activities	Data and information reflecting compliance activities [is not entered on records at the time the activity is performed or observed] [does not indicate the actual values]. Specifically***
1290	21 CFR 110.20(a)(4)	6	Waste disposal	Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where food is exposed. Specifically, ***
1643	21 CFR 113.100(c)	6	Incomplete information	Written records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions taken]. Specifically, ***
1660	21 CFR 113.40(a)(1)	6	MIG thermometer not used as reference	The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures. Specifically, ***
1691	21 CFR 113.40(a)(4)	6	Steam controller	Failure to equip retorts with automatic steam controllers to maintain retort temperatures. Specifically, ***
1731	21 CFR 113.40(a)(2)	6	Presence and accuracy	Each retort did not have an accurate temperature-recording device. Specifically, ***
1806	21 CFR 129.80(b)(1)	6	Records of mechanical washers	You do not keep records of [inspection and conditions found] [physical maintenance] [performance] for mechanical washers. Specifically, ***
1944	21 CFR 129.80(d)	6	Sanitizing operations inadequate	Sanitizing operations are not adequate to effect sanitation of the intended product water-contact surfaces and critical areas.They do not meet the minimum times and intensities required by the regulations. Specifically, ***
1945	21 CFR 129.80(d)	6	Records of sanitizing times and intensities (S)	You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in contact with the surface being sanitized]. Specifically, ***
2848	21 CFR 113.40(g)(1)(i)(b)	6	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] a known accurate mercury-in-glass thermometer. Specifically, ***
2862	21 CFR 113.40(g)(1)(i)(g)	6	Heated or inadequate slope	The product-sterilizing holding tube [was not designed to prevent heating of the tube between the product inlet and product outlet] [was not sloped upward at least 0.25 inch per foot]. Specifically, ***
3093	21 CFR 114.89	6	Process deviation evaluation - record	Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, ***
3872	21 CFR 113.60(a)(3)	6	Closures other than double seams and glass	Failure to [have a qualified person] perform appropriate detailed inspections and tests [at intervals of sufficient frequency] to ensure proper closing machine performance and consistently reliable hermetic seal production. Specifically, ***
4295	21 CFR 110.40(a)	6	Food contact - non-toxic materials	Food-contact surfaces are not made of non-toxic materials. Specifically, ***
4421	21 CFR 110.20(a)	6	Maintenance of grounds	Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
9946	21 CFR 120.11(b)	6	Validation - reviewer's qualifications	Your [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who had successfully completed training in the application of HACCP principles to juice processing or otherwise qualified through job experience to perform these function. Specifically, ***
15454	21 CFR 111.16	6	Written procedures - pest control	You did not [establish] [follow] written procedures for pest control. Specifically, ***
15458	21 CFR 111.20(d)(1)(i)	6	Floors, walls, ceilings	Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and kept clean and in good repair. Specifically, ***
15499	21 CFR 111.27(a)	6	Equipment - design - suitable	You did not use equipment or utensils of appropriate design, construction, and workmanship to enable them to be [suitable for its intended use] [adequately cleaned] [properly maintained]. Specifically, ***
15550	21 CFR 111.260(j)	6	Batch record - manufacture	Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch. Specifically, ***
15642	21 CFR 111.455(a)	6	Hold - temperature, humidity, light	You did not hold [components] [dietary supplements] under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected. Specifically, ***
15744	21 CFR 111.210(h)(2)	6	Master manufacturing record - sampling, tests, examinations	The written instructions in your master manufacturing record did not include [procedures for sampling] [a cross-reference to procedures for tests or examinations]. Specifically, ***
15748	21 CFR 111.210(f)	6	Master manufacturing record theoretical yield,expected yield	Your master manufacturing record did not include a statement of [the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished dietary supplement.]Specifically, ***
15791	21 CFR 111.403	6	Written procedures -packaging operations	You did not [establish] [follow] written procedures for packaging operations. Specifically, ***
15842	21 CFR 111.70(f)	6	Specifications - product received for packaging, labeling	You did not establish specifications to [sufficiently] assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order. Specifically, ***
15870	21 CFR 111.75(c)(1)	6	Specifications met - verify; production, process control	You did not select one or more established specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement] that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications. Specifically, ***
15872	21 CFR 111.75(c)(3)	6	Specifications met identity,purity, strength, comp,; basis	You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification[s]. Specifically, ***
15932	21 CFR 111.105(a)	6	Processes, specifications, written procedures	Your quality control personnel did not approve or reject [processes] [specifications] [written procedures] [controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength, or composition of a dietary supplement. Specifically, ***
15935	21 CFR 111.105(d)	6	Quality control - basis; tests, examinations	Your quality control personnel did not review and approve the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification will ensure that the finished batch of the dietary supplement meets product specifications. Specifically, ***
16013	21 CFR 111.140(b)(1)	6	Records - quality control operations; responsibilities	You did not make and keep written procedures for the responsibilities of the quality control operations. Specifically, ***
16014	21 CFR 111.140(b)(1)	6	QC ops; written procedures; material review, disposition	You did not make and keep [written procedures for the responsibilities of the quality control operations for conducting a material review and making a disposition decision] [written procedures for approving or rejecting any reprocessing]. Specifically, ***
16133	21 CFR 118.4(b)(2)	6	Cross contamination from equipment	You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses. Specifically,***
16141	21 CFR 118.4(c)(2)	6	Satisfactory fly control methods	When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control. Specifically,***
16172	21 CFR 118.7(a)	6	Plan appropriate to layout	The poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,***
949	21 CFR 123.12(c)	5	Records, English	The records that document the performance and results of the affirmative step you chose are not in English. Specifically, ***
1303	21 CFR 113.81(f)	5	Critical Factors	The critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal process are not controlled in a manner to ensure the limits established are not exceeded. Specifically, ***
1317	21 CFR 113.87(d)	5	Timing devices	Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved. Specifically, ***
1428	21 CFR 110.20(b)(6)	5	Adequate ventilation	Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food. Specifically, ***
1487	21 CFR 113.87(b)	5	Visual indicators not used	Heat-sensitive indicators or other means are not used to visually show that a thermal process has been applied to containers in a retort basket, truck, car, or crate used to hold containers in a retort. Specifically, ***
1534	21 CFR 113.100(b)	5	Entries not done	Required entries on [processing records] [production records] were not made by the retort or processing system operator or other designated person for specific retort operations or conditions specified in the scheduled process. Specifically, ***
1648	21 CFR 113.40(a)(1)	5	No MIG thermometer	Failure to install a mercury-in glass thermometer on each retort. Specifically, ***
1706	21 CFR 110.80(b)(10)	5	Mechanical manufacturing control	Failure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, ***
1735	21 CFR 113.40(a)(2)	5	Unauthorized adjustment	There was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
1761	21 CFR 129.80(a)	5	Record keeping requirements	You do not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the [type and date] [conditions found] [performance and effectiveness of equipment]. Specifically, ***
2275	21 CFR 129.80(g)(2)	5	Chemical, physical, radiological	You do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological] testing at least annually [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
3082	21 CFR 114.89	5	Process deviation	Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of the finished product higher than 4.6]. Specifically, ***
3648	21 CFR 110.20(a)(4)	5	Neighboring grounds	Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control. Specifically, ***
3874	21 CFR 113.60(b)	5	Cooling water - failure to chlorinate, etc.	Failure to chlorinate or otherwise sanitize container cooling water as necessary for cooling canals and recirculated water supplies. Specifically, ***
4419	21 CFR 110.10(c)	5	Level of competency (S)	Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a needed level of competency. Specifically, ***
4523	21 CFR 108.35(f)	5	Recall procedures	Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
4524	21 CFR 108.35(g)	5	Approved school	Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and packaging systems] [thermal processing systems] [container closure inspections] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
6012	21 CFR 123.8(a)(3)(iii)	5	Calibration record review adequacy	Your review of [calibration] [in-process testing][end-product testing] records does not ensure [that the records are complete] [that the activities occurred in accordance with your written procedures] [occurred within a reasonable time after the records were made]. Specifically, ***
9936	21 CFR 120.7(a)	5	Hazard analysis - written - elements	Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each food hazard identified to determine if it must be addressed in the HACCP plan] [an identification of the control measures that can be applied] [a review of your current process to determine whether modifications are necessary] [an identification of critical control points]. Specifically, ***
9986	21 CFR 120.24(c)	5	Process controls - not exempt, single facility	You do not conduct the 5-log reduction process and perform final packaging of your juice within a single production facility operating under current good manufacturing practices. Specifically, ***
12748	21 CFR 120.8(b)(5)	5	HACCP plan - corrective action plan not included	Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected]. Specifically,***
15381	21 CFR 111.8	5	Written procedures - hygienic practices	You did not [establish] [follow] written procedures for hygienic practices. Specifically, ***
15425	21 CFR 111.15(i)	5	Hand-washing facilities	Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature]. Specifically, ***
15434	21 CFR 111.15(d)(2)	5	Pest control measures	You did not take effective measures [to exclude pests from the physical plant] [to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests]. Specifically, ***
15463	21 CFR 111.20(d)(1)(v)	5	Physical plant - aisles, working spaces	Your physical plant did not have aisles or working spaces between equipment and walls that are [adequately unobstructed] [of adequate width] to permit all persons to perform their duties and to protect against contamination of components, dietary supplements, or contact surfaces with clothing or personal contact. Specifically, ***
15478	21 CFR 111.20(f)	5	Physical plant - bulbs, fixtures, skylights	You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary supplements. Specifically, ***
15491	21 CFR 111.25	5	Equipment - procedures	You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils. Specifically, ***
15493	21 CFR 111.25(b)	5	Procedures - calibrating automated, mechanical equip	You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment. Specifically, ***
15526	21 CFR 111.30(c)	5	Equipment - automated - calibrate, inspect	You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance. Specifically, ***
15542	21 CFR 111.260(b)	5	Batch record - date, time; maintenance	Your batch production records did not include the identity of equipment and processing lines used in producing the batch. Specifically, ***
15566	21 CFR 111.260(l)(3)	5	Batch record - approved, released, rejected; batch	Your batch production records did not include documentation that quality control personnel approved and released, or rejected, a batch for distribution. Specifically, ***
15582	21 CFR 111.155(e)	5	Components - contamination, deterioration, mixups	You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups]. Specifically, ***
15584	21 CFR 111.155(d)(1)	5	Components - identify lot produced	You did not identify each lot of components that you produced in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed]. Specifically, ***
15619	21 CFR 111.180(b)(1)	5	Written procedures - packaging, labeling received	You did not make and keep written procedures for fulfilling the requirements that apply to packaging and labeling received. Specifically, ***
15645	21 CFR 111.455(c)	5	Hold - mixup, contamination, deterioration	You held [components] [dietary supplements] [packaging] [labels] under conditions thatlead to mix-up, contamination, or deterioration. Specifically, ***
15662	21 CFR 111.303	5	Written procedures - laboratory operations	You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
15683	21 CFR 111.315(c)	5	Examination, testing methods; criteria for selecting	You did not [establish] [follow] laboratory control processes for use of criteria for selecting appropriate examination and testing methods. Specifically, ***
15759	21 CFR 111.205(b)(2)	5	Master manufacturing record - controls, procedures	Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,***
15930	21 CFR 111.105	5	Ensure quality; package, labeled, master record	Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding] operations ensure the quality of the dietary supplement. Specifically, ***
15986	21 CFR 111.123(b)(2)	5	Quality control - batch, product specifications	Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications. Specifically, ***
16057	21 CFR 111.535(b)(1)	5	Records - returned dietary supplement: written procedures	You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements. Specifically, ***
16156	21 CFR 118.5(b)	5	Environmental testing after induced molting period	Environmental testing of SE in a poultry house was not performed at 4 to 6 weeks after the end of the molting process which followed your inducing of a molt in a flock or a group in the flock. Specifically,***
972	21 CFR 123.8(a)(1)	4	Modification HACCP plan	You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. Specifically, ***
1176	21 CFR 110.40(f)	4	Insufficient number of Q.C. instruments	An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms. Specifically,***
1188	21 CFR 110.37(c)	4	Sewage disposal	Failure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, ***
1288	21 CFR 110.20(a)(2)	4	Roads/yards/parking lots	Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is exposed. Specifically, ***
1331	21 CFR 113.100(a)(1)	4	Still retorts	Forms used in recording specific processing and production information for still retorts lack [the time that steam was turned on] [the time that the retort reached processing temperature] [the time that steam was shut off] [venting time] [venting temperature]. Specifically, ***
1472	21 CFR 113.83	4	Critical factors not stated	Critical factors that may affect the scheduled process are not specified in the scheduledprocess. Specifically, ***
1485	21 CFR 113.87(a)	4	Scheduled processes not available	Scheduled processes were not readily available to the [retort or processing system supervisor] [FDA Investigator]. Specifically, ***
1563	21 CFR 110.35(d)(1)	4	Low-moisture food requirements	Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use. Specifically, ***
1600	21 CFR 110.37(a)	4	General inadequacy	Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, ***
1665	21 CFR 110.80(a)(2)	4	Pasteurization or other adequate treatment	[Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or other disease are not pasteurized or otherwise adequately treated. Specifically, ***
1688	21 CFR 110.80	4	Supervisory competence	The function of supervising overall sanitation of the plant has not been designated tothe supervision ofone or more competent individuals assigned responsibility for this function. Specifically, ***
1757	21 CFR 113.40(a)(8)	4	Observable	Failure to install bleeders so that the operator can observe that they are functioning properly. Specifically, ***
2298	21 CFR 129.80(f)	4	Inspection of containers and closures	You do not [sample] [inspect] all containers and closures to ascertain they are free from contamination. Specifically, ***
2301	21 CFR 129.80(f)	4	Bacteriological contamination of containers and closures (S)	You do nottake a bacteriological swab and/or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing. Specifically, ***
2387	21 CFR 110.80(a)(1)	4	Washing and cleaning	Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, ***
2847	21 CFR 113.40(g)(1)(i)(b)	4	Scale	The working scale of the temperature-recording device chart was more than 55 degrees F per inch, within a range of 20 degrees F of the product-sterilization temperature. Specifically, ***
3077	21 CFR 114.80(b)	4	Visible code	Each container is not marked with an identifying code permanently visible to the naked eye. Specifically, ***
3083	21 CFR 114.89	4	Process deviation evaluation	Process deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Specifically, ***
3644	21 CFR 110.10(b)(5)	4	Impermeable (S)	Gloves used for food handling are not impermeable. Specifically,***
3708	21 CFR 110.80(a)(1)	4	Water quality -- wash, rinse, convey food	Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, ***
3857	21 CFR 113.60(a)	4	Record of visual closure examination	Failure to record observations of visual closure examinations performed by a qualified person during production. Specifically, ***
3861	21 CFR 113.60(a)	4	Record of corrective actions	Failure to record corrective actions taken to fix irregularities in closures. Specifically, ***
4512	21 CFR 108.25(g)	4	Record retention	Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three years all records [of processing] [of deviations in processing] [specified in 21 CFR 114]. Specifically, ***
4514	21 CFR 108.35(c)(1)	4	Registration	Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of low-acid canned foods. Specifically, ***
4518	21 CFR 108.35(c)(2)(ii)	4	Process change - increase	Failure to file with FDA changes in previously filed scheduled processes, where processing parameters were higher or longer, when the processes became regularly scheduled. Specifically, ***
9917	21 CFR 120.10(c)	4	Corrective action documentation	You do not have records that [fully] document corrective actions that were taken. Specifically, ***
9943	21 CFR 120.8(a)	4	HACCP plan - location and type of juice	Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed]. Specifically, ***
9961	21 CFR 120.24(a)	4	Process controls - HACCP plan - 5 log reduction	Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product. Specifically, ***
9981	21 CFR 120.12(b)(4)	4	Records - actual values	Your records do not [always] contain the actual values and observations obtained during monitoring. Specifically, ***
12750	21 CFR 120.8(b)(6)	4	HACCP plan - valid procedures / frequency - none listed	Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to ensure that the HACCP plan is adequate to control food hazards that are reasonably likely to occur. Specifically, ***
12751	21 CFR 120.8(b)(7)	4	HACCP plan - recordkeeping system	Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, ***
15382	21 CFR 111.8	4	Written procedures - personnel qualifications	You did not [establish] [follow] written procedures for determining personnel qualification requirements. Specifically, ***
15409	21 CFR 111.14(b)(1)	4	Personnel - records - written procedures	You did not make and keep written procedures for [preventing microbial contamination from sick or infected personnel] [hygienic practices] [determining personnel qualification requirements]. Specifically, ***
15442	21 CFR 111.15(b)(1)	4	Physical plant - clean and sanitary	You did not maintain your physical plant in a clean and sanitary condition. Specifically, ***
15443	21 CFR 111.15(b)(2)	4	Physical plant - repair	You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated. Specifically, ***
15459	21 CFR 111.20(d)	4	Physical plant - design and construction	Your physical plant was not [designed] [constructed] in a manner that prevents contamination of components, dietary supplements, or contact surfaces. Specifically, ***
15462	21 CFR 111.20(d)(1)(iv)	4	Physical plant - temperature, humidity controls	Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement. Specifically, ***
15481	21 CFR 111.23(b)	4	Records - cleaning, pest control	You did not make and keep records of the written procedures for [cleaning the physical plant] [pest control]. Specifically, ***
15552	21 CFR 111.260(j)(2)	4	Batch record - initials; each step	Your batch production records did not include initials of the persons performing each step. Specifically, ***
15556	21 CFR 111.260(j)(2)(iv)	4	Batch record - initials; verifying component	Your batch production records did not include initials of the person responsible for verifying the addition of components to the batch. Specifically, ***
15572	21 CFR 111.153	4	Written procedures - labels	You did not [establish] [follow] written procedures for the requirements for labels received. Specifically, ***
15578	21 CFR 111.155(c)	4	Components - quarantine	You did not quarantine components before you used them in the manufacture of a dietary supplement. Specifically, ***
15583	21 CFR 111.155(d)(1)	4	Components - identify lot received	You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed]. Specifically,***
15698	21 CFR 111.320(a)	4	Examination, testing; appropriate	You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use. Specifically, ***
15710	21 CFR 111.325(b)(2)(i)	4	Document; laboratory methodology followed	The person who conducted the testing and examination did not document [at the time of performance] that established laboratory methodology was followed. Specifically, ***
15715	21 CFR 111.375(b)	4	Records - manufacturing operations; written procedures	You did not make and keep records of the written procedures for manufacturing operations. Specifically, ***
15743	21 CFR 111.210(h)(3)	4	Master manufacturing record - specific actions; quality	The written instructions in your master manufacturing record did not include specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
15746	21 CFR 111.210(h)(1)	4	Instructions; specifications; quality	The written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, ***
15775	21 CFR 111.415(e)	4	Dietary supplement containers - mixups	You did not [identify] [identify by effective means] filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mix-ups. Specifically, ***
15834	21 CFR 111.70(c)(2)	4	Specifications identity, purity strength, composition	You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for [the identity] [purity] [strength] [composition]. Specifically, ***
15862	21 CFR 111.75(a)(2)	4	Appropriate tests, examinations; certificate of analysis	You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications. Specifically, ***
15864	21 CFR 111.75(a)(2)(ii)(C)	4	Documentation - qualify supplier	You did not maintain documentation of how you qualified the supplier of a component. Specifically, ***
15920	21 CFR 111.95(b)(1)	4	Records - established specifications	You did not make and keep records of established specifications. Specifically, ***
15944	21 CFR 111.105(i)	4	QC - required operations master manufacturing/batch records	Your quality control personnel did not perform required operations for the [master manufacturing record] [batch record] [manufacturing operations]. Specifically, ***
15970	21 CFR 111.120	4	Quality control operations - components, packaging, labels	You do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically, ***
15984	21 CFR 111.123(a)(8)	4	Quality control - finished batch, distribution	Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution. Specifically, ***
15989	21 CFR 111.127	4	Quality control operations - packaging, labeling	You do not have quality control operations for [packaging] [labeling]. Specifically, ***
16007	21 CFR 111.135	4	Quality control operations - product complaints	You do not have quality control operations for product complaints. Specifically, ***
16058	21 CFR 111.535(b)(2)	4	Records - ret'nd dietary supplement: material review, dispos	You did not make and keep records of a material review and disposition decision on a returned dietary supplement. Specifically, ***
16150	21 CFR 118.4(e)	4	Eggs to be processed as table eggs	Eggs intended to be processed as table eggs [were not held and transported as required at or below 45 deg. F] [were held at room temperature for more than 36 hours just prior to processing]. Specifically,***
16190	21 CFR 118.10(a)(1)	4	Written SE prevention plan	You do not have a written SE prevention plan. Specifically,***
17004	FDCA 402(a)	4	Food Field Exam	During a field examination of food products at your facility the following [was] [were] observed:
977	21 CFR 123.9(b)(3)	3	Records stored at another location	You did not immediately return your records for official review upon demand. Specifically, ***
1093	21 CFR 110.40(g)	3	Compressed air/gases	Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated with unlawful indirect food additives. Specifically, ***
1197	21 CFR 110.10(a)	3	Lack of instruction/reporting of health conditions	Personnel withadverse health conditions are not instructed to report to their supervisors. Specifically, ***
1245	21 CFR 113.81(a)	3	Raw ingredients	There was no means to assure that raw materials and ingredients susceptible to microbiological contamination were suitable for use in processing low-acid food. Specifically, ***
1359	21 CFR 129.35(a)(3)(i)	3	Maintaining sample & analysis records	You do not maintain records on file at the plant pertaining to [approval of the source water by government agencies] [sampling and analyses for which you are responsible]. Specifically, ***
1569	21 CFR 110.35(d)(2)	3	Continuous operations	Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary. Specifically, ***
1645	21 CFR 113.100(c)	3	Records review infrequent / not done	Written records of all container closure examinations are [not reviewed by management] [not reviewed by management with sufficient frequency] to ensure that the containers are hermetically sealed. Specifically, ***
1740	21 CFR 113.40(a)(2)	3	Well bleeder	Failure to have a 1/16-inch or larger bleeder. Specifically, ***
1751	21 CFR 113.40(a)(8)	3	Size, fully open	Bleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***
1752	21 CFR 113.40(a)(8)	3	Location - from ends	Bleeders on horizontal retorts are not installed [approximately one foot from the outermost end at both ends of the retort] [on top of the retort]. Specifically, ***
1754	21 CFR 113.40(a)(8)	3	Location - separation	Bleeders on horizontal retorts are installed more than eight feet apart. Specifically, ***
1764	21 CFR 129.80(b)(1)	3	Multiservice primary containers	You do not adequately [clean] [sanitize] [inspect] multiservice primary containers just prior to the containers being filled, capped and sealed. Specifically, ***
1812	21 CFR 129.80(c)	3	Testing of cleaning/sanitizing solutions	You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, ***
2149	21 CFR 113.40(b)(1)	3	Not used as reference	A mercury-in-glass thermometer was not the reference instrument used for indicating processing temperatures. Specifically, ***
2362	21 CFR 110.80	3	Reject and rework	Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination.. Specifically, ***
2843	21 CFR 113.40(g)(1)(i)(a)	3	Not used as reference	The temperature-indicating device was not used as the reference instrument for indicatingprocessing temperatures. Specifically, ***
2869	21 CFR 113.40(g)(1)(ii)(e)	3	Readings at start of aseptic processing	Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic processing to ensure the values were as specified in the scheduled process for aseptic packaging operations. Specifically, ***
2888	21 CFR 113.40(j)	3	Critical factors	Critical factors are not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
3079	21 CFR 114.80(b)	3	Code - packing period	The packing period is not changed often enough to enable ready identification of lots during sale and distributionSpecifically, ***
3710	21 CFR 110.80(b)(16)	3	Ice manufacturing	Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality]. Specifically, ***
3870	21 CFR 113.60(a)(2)	3	Glass containers, capper efficiency check	Failure to measure the cold water vacuum of the glass container capper before actual filling operations. Specifically, ***
3876	21 CFR 113.60(c)	3	Coding - failure to mark	Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye. Specifically, ***
4062	21 CFR 113.100(a)	3	Critical factors - entry missing information	Forms used to record critical factors lack [closing machine vacuum in vacuum-packed products] [maximum fill-in weight] [drained weight] [critical factors specified in the scheduled process]. Specifically, ***
9921	21 CFR 120.10(b)	3	Corrective action - no predetermined plan	Your HACCP plan does not include a corrective action plan.There was a deviation from a critical limit and you did not take corrective action that ensured [affected product was segregated and held] [a review of the affected product by someone who is adequately trained or experienced was done to determine its acceptability] [product that was injurious to health or otherwise adulterated was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was verified by someone meeting the training requirements of the regulation to determine if modifications were needed to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary]. Specifically, ***
9959	21 CFR 120.12(d)(1)	3	Record retention - general	You do not retain [all of] the required records at your facility for the required time period. Specifically, ***
12707	21 CFR 129.80(g)(3)	3	Records of analyses	For analyses of bottled water, you do not maintain records of [date of sampling] [type of product] [production code] [results]. Specifically, ***
12717	21 CFR 129.80(h)	3	Certificates	You did not retain at the plant current certificates or notifications of approval issued by the government agency or agencies approving the source and supply of product water and operations water. Specifically, ***
12732	21 CFR 120.10(a)	3	Corrective action - predetermined plan	Your HACCP plan includes a corrective action plan.There was a deviation from a critical limit and you did not take corrective action that ensured [product that was injurious to health or otherwise adulterated did not enter commerce] [the cause of the deviation was corrected]. Specifically, ***
15351	FDCA 761(b)(1)	3	No AE report made (dietary supplement)	No report was made of a serious adverse event associated with a dietary supplement marketed in the United States. Specifically, ***
15380	21 CFR 111.8	3	Written procedures - sick or infected personnel	You did not [establish] [follow] written procedures for preventing microbial contamination from sick or infected personnel. Specifically, ***
15388	21 CFR 111.10(b)	3	Personnel - hygienic practices	Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces. Specifically, ***
15403	21 CFR 111.12(b)	3	Personnel - quality control operations; responsibilities	The personnel you identified to perform quality control operations do not have distinct and separate responsibilities related to performing such operations from those responsibilities that the personnel otherwise have when not performing such operations. Specifically, ***
15429	21 CFR 111.15(k)	3	Sanitation supervisors - assigned	You did not assign one or more employees to supervise overall sanitation. Specifically, ***
15437	21 CFR 111.15(a)(1)	3	Grounds - equipment, litter, weeds	You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant. Specifically, ***
15447	21 CFR 111.15(c)(3)	3	Cleaning compounds and toxic materials - holding	You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces. Specifically, ***
15450	21 CFR 111.15(f)(3)	3	Plumbing - source of contamination	The plumbing in your physical plant was not adequate to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface or creating an unsanitary condition. Specifically, ***
15452	21 CFR 111.15(f)(5)	3	Plumbing - backflow, cross connection	The plumbing in your physical plant allows [backflow from] [cross connection between] piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities. Specifically, ***
15468	21 CFR 111.20(c)(2)	3	Physical plant - material review and disposition	You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplements by separating components, dietary supplements, packaging, and labels that are to be used in manufacturing from those that are awaiting material review and disposition decision, reprocessing, or disposal. Specifically, ***
15469	21 CFR 111.20(c)(3)	3	Physical plant - separate areas for products	You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplementby separating the [manufacturing] [packaging] [labeling] [holding] of different product types. Specifically, ***
15482	21 CFR 111.23(c)	3	Records - water	You did not make and keep records that show that the water you use [complies with applicable Federal, State, and local requirements] [does not contaminate the dietary supplement]. Specifically, ***
15505	21 CFR 111.27(a)(3)(v)	3	Equipment - protect from contamination	Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated. Specifically, ***
15507	21 CFR 111.27(a)(5)(i)	3	Refrigerator, freezer - temperature recording device	Your freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary supplements does not have an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the accurate temperature within the compartment. Specifically, ***
15510	21 CFR 111.27(a)(7)	3	Compressed air, gases	The compressed air or other gases you introduced mechanically into or onto a component, dietary supplement, or contact surface or that you used to clean any contact surface was not treated in such a way that the component, dietary supplement, or contact surface is not contaminated. Specifically, ***
15525	21 CFR 111.30(b)	3	Equipment - automated - suitability	You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process. Specifically, ***
15546	21 CFR 111.260(f)	3	Batch record - yield	Your batch production records did not include [a statement of the actual yield] [a statement of the percentage of theoretical yield] at appropriate phases of processing. Specifically, ***
15547	21 CFR 111.260(g)	3	Batch record - results; monitoring	Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,***
15560	21 CFR 111.260(k)(2)	3	Batch record - label	Your batch production records did not include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. Specifically, ***
15567	21 CFR 111.260(l)(4)	3	Batch record - approved, released, rejected	Your batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement. Specifically, ***
15586	21 CFR 111.155(e)	3	Components - contamination, deterioration, mixups	You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups]. Specifically, ***
15624	21 CFR 111.180(b)(3)	3	Documentation - components	You did not make and keep documentation that the requirements that apply to production and process control for components of dietary supplements were met. Specifically, ***
15660	21 CFR 111.475(b)(2)	3	Records - product distribution	You did not make and keep records of product distribution. Specifically, ***
15665	21 CFR 111.303	3	Written procedures - tests, examinations; specifications met	You did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met. Specifically, ***
15675	21 CFR 111.315(b)	3	Sampling plans; establish, follow	You did not [establish] [follow] sampling plans for obtaining representative samples. Specifically, ***
15702	21 CFR 111.320(b)	3	Examination, testing; scientifically valid	You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met. Specifically, ***
15722	21 CFR 111.365(j)	3	Containers - segregating, identifying	You did not segregate and identify containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing. Specifically, ***
15723	21 CFR 111.365(i)	3	Metal, foreign material	You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements]. Specifically, ***
15728	21 CFR 111.365(d)	3	Chemical,microbiological,other test-contaminated components	You did not perform chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components. Specifically, ***
15734	21 CFR 111.360	3	Manufacturing operations - sanitation	You did not conduct manufacturing operations in accordance with adequate sanitation principles. Specifically, ***
15740	21 CFR 111.210(h)(3)(ii)(A)	3	Instructions; components; weight, measure	The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person weighing or measuring and another person verifying the weight or measure of components. Specifically, ***
15750	21 CFR 111.210(d)	3	Master manufacturing record - ingredients list	Your master manufacturing record did not include the identity of each ingredient that will be declared on the ingredients list of the dietary supplement. Specifically, ***
15760	21 CFR 111.205(b)(1)	3	Master manufacturing record-specifications; packaged, label	Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
15799	21 CFR 111.560(a)(1)	3	Product complaint - quality control review	A qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements. Specifically, ***
15801	21 CFR 111.560(b)	3	Quality control, review, approve; investigate, followup	Your quality control personnel did not [review and approve decisions about whether to investigate a product complaint] [review and approve the findings and follow-up action of an investigation]. Specifically, ***
15825	21 CFR 111.65	3	Quality control - quality, dietary supplement	You did not implement quality control operations to ensure the quality of the dietary supplement. Specifically,***
15826	21 CFR 111.65	3	Quality control - packaged, labeled	You did not implement quality control operations to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
15832	21 CFR 111.70(c)(1)	3	In-process identity, purity, strength, composition	You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for [identity] [purity] [strength] [composition]. Specifically, ***
15840	21 CFR 111.70(e)	3	Specifications -contamination limits	You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement. Specifically, ***
15843	21 CFR 111.70(g)	3	Specifications - finished packaging, labeling	You did not establish specifications [for the packaging and labeling of the finished dietary supplement] [to ensure that you used the specified packaging] [to ensure that you applied the specified label]. Specifically, ***
15863	21 CFR 111.75(a)(2)(ii)(B)	3	Component - certificate of analysis	The certificate of analysis for a component does not include [a description of the test or examination method(s) used] [limits of the test or examination] [actual results of the tests or examinations]. Specifically, ***
15893	21 CFR 111.80(c)	3	Specifications - representative samples; finished batch	You did not collect representative samples [of a subset] of finished batches of dietary supplements that you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement meets established product specifications. Specifically, ***
15902	21 CFR 111.83(b)(4)	3	Reserve sample - twice the quantity	Your reserve sample did not consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications. Specifically, ***
15921	21 CFR 111.95(b)(2)	3	Documentation - supplier qualification	You did not make and keep documentation of your qualification of a supplier. Specifically,***
15963	21 CFR 111.113(b)(2)	3	Quality control - reject; specification not met	Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met. Specifically, ***
16000	21 CFR 111.130	3	Quality control operations - returned dietary supplement	You do not have quality control operations for returned dietary supplements. Specifically, ***
16020	21 CFR 111.140 (b)(3)(ii)	3	Material review, disposition, follow-up; investigation	Your documentation of your material review and disposition decision and follow-up did not include a description of your investigation into the cause of the deviation from the specification or of the unanticipated occurrence. Specifically, ***
16037	21 CFR 111.605	3	Records - keep: 1 year, 2 years	You did not keep required written records for 1 year past the shelf life date or for 2 years beyond the date of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
16074	21 CFR 111.35(b)(4)	3	Records - equipment; calibrations, inspections, checks	You did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, or electronic equipment. Specifically, ***
16131	21 CFR 118.4(b)	3	Transfer or introduction of SE	You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or among poultry houses. Specifically,***
16157	21 CFR 118.5(b)(1)	3	SE testing 4 to 6 weeks after each molting process	You did not perform environmental testing for SE 4 to 6 weeks after the end of the molting process each time a flock or group within the flock was molted. Specifically***
16185	21 CFR 118.9	3	Supervisor duties	You lack [qualified] supervisory personnel who are responsible for [development and implementation of an SE plan that is appropriate for your farm and meets the regulatory requirement] [reassessing and modifying the SE prevention plan as necessary] [reviewing records created to document the SE prevention measures]. Specifically, ***
899	21 CFR 123.16	2	Process controls	Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
939	21 CFR 123.9(f)	2	Computerized records	Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. Specifically, ***
976	21 CFR 123.9(b)(2)	2	Process adequacy records	The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their applicability to the product you produced. Specifically, ***
1276	21 CFR 129.20(c)	2	Adequate ventilation	The ventilation in the [processing room] [bottling room] [container washing and sanitizing area] is not adequate to minimize condensation. Specifically, ***
1319	21 CFR 113.87(f)	2	Steam supply	The steam supply to the thermal processing system was not adequate to maintain sufficient steam pressure during the thermal processing of containers. Specifically, ***
1329	21 CFR 113.100(a)	2	Processing entries not done/not timely	Required information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person. Specifically, ***
1379	21 CFR 129.35(a)(4)(iv)	2	Compliance with standards	Finished bottled water does not comply with bottled water quality standards. Specifically, ***
1417	21 CFR 129.37(c)	2	Exam, handling of single service containers et. al.	Single service [containers] [caps] [seals] are not [examined] [washed, rinsed and sanitized when necessary] [handled in a sanitary manner] prior to use. Specifically, ***
1423	21 CFR 129.37(d)	2	Containers kept sanitary	You do not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude contamination of the bottled drinking water. Specifically, ***
1453	21 CFR 129.40(a)(1)	2	Suitability - equipment and utensils	Not all plant equipment and utensils are suitable for their intended use. Specifically, ***
1473	21 CFR 113.83	2	Scientific methods not performed	No acceptable scientific methods of establishing heat sterilization processes or procedures recognized by competent processing authorities were used in the determination of the scheduled process. Specifically, ***NOTE: CFSAN CONCURRENCE REQUIRED.
1484	21 CFR 113.87(a)	2	Vent not posted	Retort venting procedures for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators]. Specifically, ***
1499	21 CFR 113.89	2	No corrective action taken	No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a deviation from the scheduled process was found. Specifically, ***
1532	21 CFR 113.100(a)(7)	2	Other systems	Forms used in recording specific processing and production information for other systems lack critical factors specified in the formulation of the product or in the scheduled process. Specifically, ***
1559	21 CFR 110.35(c)	2	Guard/guide dogs	The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
1640	21 CFR 113.100(b)	2	Entries not signed	The retort or processing system operator or other designated person did not initial or sign each record form. Specifically, ***
1651	21 CFR 113.40(a)(1)	2	Thermometer calibration	Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy. Specifically, ***
1732	21 CFR 113.40(a)(2)	2	Range	Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature. Specifically, ***
1733	21 CFR 113.40(a)(2)	2	Scale	The working scale of the temperature-recording device chart was more than 55 degrees F per inch, within a range of 20 degrees F of the processing temperature. Specifically, ***
1865	21 CFR 113.40(a)(12)	2	Short vent	Timing of a process began before the retort [was properly vented] [processing temperature was reached]. Specifically, ***
1962	21 CFR 129.80(h)	2	Two year requirement	You did not retain at the plant required records for at least 2 years. Specifically, ***
2065	21 CFR 123.28(c)	2	Shellstock records	You do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification number of the harvester issued by the shellfish control authority]. Specifically, ***
2104	21 CFR 113.40(a)(13)(iii)	2	15 minute interval (S)	Failure to make measurements and recordings of critical factors specified in the scheduled process at intervals not to exceed 15 minutes. Specifically, ***
2154	21 CFR 113.40(b)(2)	2	Unauthorized adjustment	There was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
2271	21 CFR 129.80(e)	2	Package identification	You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production code which identifies [the particular batch] [the segment of production run] [the day produced]. Specifically, ***
2273	21 CFR 129.80(g)	2	Representative samples	Samples for [bacteriological] [chemical] [physical] [radiological] analysis are not primary containers or unit packages from a batch or segment of a continuous run for each type of bottled drinking water. Specifically, ***
2503	21 CFR 113.40(e)(2)	2	Unauthorized adjustment	There was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
2826	21 CFR 113.40(g)(1)(ii)(a)	2	Startup	Failure to bring the [product sterilizer] [all product contact surfaces downstream from the sterilizer] to a condition of commercial sterility before the start of aseptic processing operations. Specifically, ***
2833	21 CFR 113.40(g)(2)(ii)(a)	2	Startup	Failure to bring both the container and closure sterilizing system and the product filling and closing system condition of commercial sterility before the start of aseptic packaging operations. Specifically, ***
2837	21 CFR 113.40(g)(4)	2	Critical factors	Critical factors were not [measured] [recorded on the processing record] at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. Specifically, ***
2844	21 CFR 113.40(g)(1)(i)(b)	2	Presence and accuracy	Each product sterilizer was not equipped with an accurate temperature-recording device. Specifically, ***
2846	21 CFR 113.40(g)(1)(i)(b)	2	Range	Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature. Specifically, ***
2853	21 CFR 113.40(g)(1)(i)(e)	2	Presence and accuracy of recorder-controller	There is no accurate differential pressure recorder-controller installed on theproduct-to product regenerator. Specifically, ***
2892	21 CFR 113.40(g)(2)(i)(b)	2	Retention time	No method is used to give the retention time of [containers] [closures] in the sterilizing environment specified in the scheduled process. Specifically, ***
3074	21 CFR 114.80(a)(2)	2	Using pH meter	Failure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH] when the finished equilibrium pH is above 4.0. Specifically, ***
3091	21 CFR 114.100(e)	2	Retention	Required records are not maintained at the processing plant or other reasonably accessible location for a period of three years from the date of manufacture. Specifically, ***
3771	21 CFR 113.40(a)(7)	2	Location of steam spreader perforations (S)	Perforations in the steam spreader along the bottom of the retortare not located along the top 90 degrees of the steam spreader. Specifically, ***
3859	21 CFR 113.60(a)	2	Frequency of visual closure examinations (S)	Failure to record visual container closure observations [at intervals of thirty (30) minutes or less] [following a jam in a closing machine] [after closing machine adjustment] [after startup following a prolonged shutdown]. Specifically, ***
3860	21 CFR 113.60(a)	2	Pertinent observations	Failure to record all pertinent visual closure observations. Specifically, ***
3864	21 CFR 113.60(a)(1)	2	Recording of teardown examinations	Failure to record teardown examinations of double seam cans [at intervals of sufficient frequency] [on enough containers from each seaming station] to ensure maintenance of seam integrity. Specifically, ***
3869	21 CFR 113.60(a)(1)(ii)	2	Method of taking seam measurements (micrometer)	Failure to measure can double seam characteristics using amicrometer at three different points approximately 120 degrees apart, excluding the side seam. Specifically, ***
3873	21 CFR 113.60(a)(3)	2	Records of closure examinations other than cans or glass	Failure to maintain records of the results of inspections and tests performed on closing machines. Specifically, ***
3875	21 CFR 113.60(b)	2	Cooling water - residual sanitizer (S)	No measurable residual of the cooling water sanitizer at the water discharge point of the container cooler. Specifically, ***
3887	21 CFR 113.89	2	Methods of process deviation evaluation	Failure to use procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health in the evaluation of a deviation from the scheduled process. Specifically, ***
4173	21 CFR 113.40(g)(1)(i)(a)	2	Date last tested for accuracy (S)	Failure to provide a tag, seal, or other means of identity, including the date of last calibration of the mercury-in-glass thermometer. Specifically, ***
4178	21 CFR 113.83	2	Commercial production variations	Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process. Specifically, ***
4179	21 CFR 113.83	2	Records of process establishment	Failure to maintain complete records covering all aspects of the establishment of the [process] [associated incubation tests] by the person or organization making the determination. Specifically, ***
4465	21 CFR 114.100(c)	2	Process deviations - action to rectify	Failure to record the action taken to rectify a departure from a scheduled process. Specifically, ***
4517	21 CFR 108.35(c)(2)(ii)	2	Process change substantiation	Failure to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process, where the change is basic to the adequacy of that scheduled process. Specifically, ***
4521	21 CFR 108.35(d)	2	Notify FDA - spoilage	Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed. Specifically, ***
4528	21 CFR 108.35(c)(2)(ii)	2	Process change recording	For an intentional change in a previously filed scheduled process, substantiation was not [promptly recorded] [verified in writing by the authority] [placed in your files for review by FDA]. Specifically, ***
9933	21 CFR 120.6(b)	2	GMP correction - timely	You do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, ***
9953	21 CFR 120.11(a)(1)(iv)(A)	2	CCP record review adequacy	Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that are within critical limits]. Specifically, ***
12704	21 CFR 129.80(a)	2	Analytical frequency	You do not analyze product water samples as often as necessary to assure uniformity and effectiveness of the treatment processes performed by the plant. Specifically, ***
12709	21 CFR 129.80(c)	2	Records of cleaning/sanitizing solutions	You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
12733	21 CFR 120.11(a)(1)(iv)(C)	2	Calibration, testing - record review timeliness	You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records within a reasonable time after the records were made. Specifically, ***
12736	21 CFR 120.12(e)	2	Records - review and copying	You did not make all required records available for review and copying at reasonable times. Specifically, ***
12744	21 CFR 120.8(b)(4)	2	HACCP plan - monitoring procedures - none listed	Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance with the critical limits. Specifically, ***
15305	21 CFR 120.14(a)(2)	2	Importer - implementation of affirmative steps	You have not implemented affirmative steps to ensure juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, ***
15396	21 CFR 111.10(b)(6)	2	Hair restraints	Your personnel did not wear [effective] hair restraints [in an effective manner]. Specifically, ***
15500	21 CFR 111.27(a)(2)	2	Equipment - design - no contamination	You used equipment or utensils that were not of appropriate design and construction so that the use resulted in contamination of components or dietary supplements. Specifically, ***
15529	21 CFR 111.30(e)	2	Equipment - controls, intended use	You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use. Specifically, ***
15533	21 CFR 111.255(c)	2	Batch record - follow master	Your batch production record did not accurately follow the appropriate master manufacturing record. Specifically, ***
15534	21 CFR 111.255(c)	2	Batch record - each step	You did not perform each step in the production of a batch, according to the master production record. Specifically, ***
15545	21 CFR 111.260(e)	2	Batch record - component; identity, weight	Your batch production records did not include the [identity] [weight or measure] of each component used. Specifically, ***
15549	21 CFR 111.260(i)	2	Batch record - specifications	Your batch production records did not include documentation that the finished dietary supplement meets established specifications. Specifically, ***
15554	21 CFR 111.260(j)(2)(ii)	2	Batch record - initials; verifying weight	Your batch production records did not include the initials of the person responsible for verifying the weight or measure of each component used in the batch. Specifically, ***
15559	21 CFR 111.260(k)(1)	2	Batch record - identifier; labels	Your batch production records did not include [the unique identifier assigned to labels used] [the quantity of the labels used] [reconciliation of discrepancies between issuance and use of labels]. Specifically, ***
15563	21 CFR 111.260(l)(1)(i)	2	Batch record - quality control review; monitoring	Your batch production records did not include documentation that quality control personnel reviewed required monitoring operations. Specifically, ***
15564	21 CFR 111.260(l)(1)(ii)	2	Batch record - quality control; tests, examinations	Your batch production records did not include documentation that quality control personnel reviewed the results of tests and examinations. Specifically, ***
15571	21 CFR 111.153	2	Written procedures - packaging	You did not [establish] [follow] written procedures for the requirements for packaging received. Specifically, ***
15573	21 CFR 111.153	2	Written procedures - product received; packaging, labeling	You did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement. Specifically, ***
15576	21 CFR 111.155(a)	2	Visually examine - containers	You did not visually examine each immediate container, or grouping of immediate containers in a shipment, for [appropriate content label] [container damage] [broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components]. Specifically,***
15589	21 CFR 111.160(c)	2	Packaging, labels - quarantine	You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement. Specifically, ***
15597	21 CFR 111.160(c)(3)	2	Labels - quality control; approve, release	Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement and release them from quarantine. Specifically, ***
15599	21 CFR 111.160(d)(1)	2	Labels - identify	You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels] [the dietary supplement that you distributed]. Specifically, ***
15604	21 CFR 111.165(b)	2	Product received - visually examine invoice, guarantee, cert	You did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received product to ensure that the received product was consistent with your purchase order. Specifically, ***
15605	21 CFR 111.165?	2	Product received - quarantine	You did not quarantine received product. Specifically, ***
15615	21 CFR 111.180(a)	2	Records - components, packaging, labels, product received:	You did not keep records required for [components] [packaging] [labels] [product received for packaging or labeling] for the required time period. Specifically, ***
15646	21 CFR 111.460(a)	2	Hold, identify - in-process material	You did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration. Specifically, ***
15673	21 CFR 111.315(a)	2	Criteria for establishing specifications	You did not [establish] [follow] laboratory control processes for use of criteria for establishing appropriate specifications. Specifically, ***
15681	21 CFR 111.315(d)	2	Standard reference materials; criteria for selecting	You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations. Specifically, ***
15689	21 CFR 111.315(b)(3)	2	Sampling plans; finished batches	You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of dietary supplements. Specifically,***
15724	21 CFR 111.365(h)	2	Mechanical steps - contamination	You did not perform mechanical manufacturing steps by effective means to protect the dietary supplements against contamination. Specifically, ***
15732	21 CFR 111.365(a)	2	Conditions, controls -protect; microorganisms, contamination	You did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination]. Specifically, ***
15733	21 CFR 111.365	2	Manufacturing operations - prevent contamination	You did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of [components] [dietary supplements]. Specifically, ***
15741	21 CFR 111.210(h)(3)(i)	2	Components, verify weight,measure	The written instructions in your master manufacturing record did not include instructions to verify the weight or measure and addition of components. Specifically,***
15745	21 CFR 111.210(h)(1)	2	Instructions; specifications; packaged, labeled	The written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically,***
15751	21 CFR 111.210(d)	2	Master manufacturing record - Supplemental Facts	Your master manufacturing record did not include the [identity] [weight or measure] of each dietary ingredient that will be declared on the Supplement Facts label. Specifically, ***
15753	21 CFR 111.210(b)	2	Master manufacturing record - list components	Your master manufacturing record did not include a complete list of components to be used. Specifically, ***
15766	21 CFR 111.430(a)	2	Records - packaging, labeling operations: 1 year, 2 years	You did not keep the records required for your packaging and labeling operations for the required time period. Specifically, ***
15778	21 CFR 111.415(b)	2	Dietary supplement - protect, contamination	You did not protect manufactured dietary supplements from contamination during [filling] [assembling] [packaging] [labeling] operations. Specifically, ***
15781	21 CFR 111.415	2	Fill, assemble, package, label - quality	You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured the quality of the dietary supplement. Specifically, ***
15783	21 CFR 111.410(d)	2	Manufacturing history	You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution. Specifically, ***
15787	21 CFR 111.410(b)	2	Packaging - issuance, use	You did not control the [issuance] [use] of packaging. Specifically, ***
15802	21 CFR 111.560(c)	2	Product complaint - review, investigation	Your review and investigation of a product complaint did not extend to all relevant batches and records. Specifically, ***
15810	21 CFR 111.570(b)(2)	2	Record - product complaint; good manufacturing practice	You did not make and keep a written record of every product complaint that was related to good manufacturing practice. Specifically, ***
15835	21 CFR 111.70(c)(2)	2	Documentation specifications - contamination limits	You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, ***
15845	21 CFR 111.73	2	Specifications met - quality	You did not determine whether you met specifications established to ensure the quality of the dietary supplement. Specifically, ***
15871	21 CFR 111.75(c)(2)	2	Specifications met - test, examinations; compliance	You did not conduct appropriate tests or examinations to determine compliance with the specifications established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]. Specifically, ***
15878	21 CFR 111.75(e)	2	Product - visually examine, identified	You did not [visually examine a product that you received for packaging or labeling] [have documentation that the product you received for packaging or labeling is adequately identified and is consistent with your purchase order]. Specifically, ***
15880	21 CFR 111.75(f)(2)	2	Label - visual examination, review supplier's documentation	You did not [conduct a visual examination of the label] [review the supplier's invoice, guarantee, or certification] to determine whether label specifications are met. Specifically, ***
15882	21 CFR 111.75(h)(2)	2	Tests, examinations - scientifically valid	You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods. Specifically, ***
15891	21 CFR 111.80(a)	2	Components packaging, labels received	You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you received from a supplier to determine whether the [components] [packaging] [labels] meet[s] established specifications. Specifically, ***
15899	21 CFR 111.83(b)(1)	2	Reserve sample container-closure contamination,deterioration	Your reserve sample of a dietary supplement that was distributed to bepackaged and labeled was not held using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it was distributed for packaging and labeling elsewhere. Specifically, ***
15901	21 CFR 111.83(b)(3)	2	Reserve sample - retained	You did not retain reserve samples for the required time. Specifically, ***
15908	21 CFR 111.90(b)(1)	2	Reprocessed, dietary supplement - no material review	You reprocessed a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the reprocessing]. Specifically, ***
15922	21 CFR 111.95(b)(3)	2	Documentation - ensure specifications met	You did not make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for [identity][ purity][ strength][ composition][ limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement]. Specifically, ***
15923	21 CFR 111.95(b)(4)	2	Documentation - specifications met; test, examinations	You did not make and keep documentation for why the results of tests or examinations you selected for the product specifications ensure that the dietary supplement meets all product specifications. Specifically, ***
15933	21 CFR 111.105(b)	2	Quality control - supplier qualification	Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers. Specifically, ***
15938	21 CFR 111.105(f)	2	Quality control - representative samples	Your quality control personnel did not ensure that required representative samples are collected. Specifically, ***
15945	21 CFR 111.105(i)	2	QC - required operations packaging/labeling operations	Your quality control personnel did not perform required operations for [packaging] [labeling] operations. Specifically, ***
15947	21 CFR 111.105(i)	2	Quality control - required operations product complaints	Your quality control personnel did not perform required operations for product complaints. Specifically, ***
15953	21 CFR 111.113(a)(1)	2	QC production, process control; material review, disposition	Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met. Specifically, ***
15964	21 CFR 111.113(c)	2	Document - material review, disposition	The person who conducted a material review and made the disposition decision did not document the material review and the disposition decision [at the time of performance]. Specifically, ***
15967	21 CFR 111.117(b)	2	Quality control operations - calibration records	Your quality control operations did not include periodically reviewing all records for calibration of instruments and controls. Specifically, ***
15972	21 CFR 111.120(b)	2	QC operations -specifications; components, packaging, labels	Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications. Specifically,***
15975	21 CFR 111.120(e)	2	Quality control operations - quarantine	Your quality control operations did not include approving, and releasing from quarantine, all [components] [packaging] [labels] before they were used. Specifically, ***
15977	21 CFR 111.123(a)(1)	2	QC operations - master manufacturing record, modifications	Your quality control operations did not include reviewing and approving [master manufacturing records] [modifications to the master manufacturing records]. Specifically, ***
16011	21 CFR 111.140(a)	2	Records - quality control operations:electronic	Your electronic records for your quality control operations do not comply with the electronic records requirements. Specifically,***
16038	21 CFR 111.605(b)	2	Records - original, true copies	You did not keep original records, true copies, or electronic records. Specifically,***
16065	21 CFR 111.35(b)(1)	2	Written procedures - equipment, utensils; make, keep	You did not make and keep written procedures for fulfilling the requirements for equipment and utensils. Specifically, ***
16066	21 CFR 111.35(b)(1)(i)	2	Written procedures -instruments, controls; calibrating	You did not make and keep written procedures for calibrating instruments or controls that you use in [manufacturing] [testing] a component or dietary supplement. Specifically, ***
16071	21 CFR 111.35(b)(3)	2	Documentation - instruments, controls; calibrations	You did not make and keep documentation of calibrations for instruments or controls that you use in manufacturing or testing a component or dietary supplement. Specifically, ***
16083	21 CFR 111.35(b)(6)	2	Documentation - equipment functions; intended use	You did not make and keep documentation of the controls you use to ensure that equipment functions according to its intended use. Specifically, ***
16168	21 CFR 118.6(f)	2	Labeling on diverted eggs	For eggs being diverted to treatment, the statement "Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f)" fails to appear [on the pallet, case or other shipping container] [on all documents accompanying the shipment] [in a legible and conspicuous manner]. Specifically,***
16171	21 CFR 118.7(a)	2	Environmental test	An environmental test for SE was not done for each poultry house as required. Specifically,***
16189	21 CFR 118.10(c)	2	Records retention time	All records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production. Specifically,***
16191	21 CFR 118.10(a)(2)	2	Pullets records documentation	You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE monitored" conditions] [that adequate environmental testing records for pullets were kept as required by CFR regulations]. Specifically,***
16194	21 CFR 118.10(a)(3)(iii)	2	Depopulation cleaning and disinfection procedures	You did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation. Specifically,***
16196	21 CFR 118.10(a)(3)(v)	2	Sampling procedures documentation	You did not maintain records documenting compliance with environmental and egg sampling procedures. Specifically,***
930	21 CFR 123.8(c)	1	Verification - hazard analysis reassessment	In the absence of a HACCP plan, you did not reassess the adequacy of your hazard analysis after changes were made to the product or the process that could reasonably affect whether a food safety hazard now exists. Specifically, ***
1258	21 CFR 113.60(c)	1	Coding - visible	Hermetically sealed containers do not have an identifying code permanently visible to the naked eye. Specifically ***
1277	21 CFR 129.20(d)	1	Enclosed room for container washing and sanitizing	You do not [wash] [sanitize] containers for bottled drinking water in an enclosed room. Specifically, ***
1300	21 CFR 113.81(c)	1	Fill	The filling of containers is not controlled to ensure that the filling requirements specified in the scheduled process are met. Specifically, ***
1302	21 CFR 113.81(e)	1	pH	The equilibrium pH of the finished product is not controlled so as to meet the pH requirements in the scheduled process. Specifically, ***
1304	21 CFR 129.35(a)(1)	1	Product water quality	The product water supply source is not [properly located, protected and operated] [easily accessible] [adequate] [of a safe, sanitary quality] [in conformance at all times with the applicable laws and regulations]. Specifically, ***
1351	21 CFR 129.35(a)(3)(i)	1	Sampling of product & ops water	You do not take and analyze samples of [product] [operations] source water [as often as necessary] [at least once every year for chemical contamination] [at least once every four years for radiological contaminants]. Specifically, ***
1353	21 CFR 129.35(a)(3)(i)	1	Sampling for micro contaminants	The [product] [operations] source water that is obtained from other than a public water system is not sampled and analyzed for microbiological contaminants at least once each week. Specifically, ***
1364	21 CFR 129.35(a)(3)(ii)	1	Test and sample methods	The [test] [sample] methods for [product] [operations] source water are [not recognized and approved by the government agency or agencies having approval over the water source] [not consistent with the minimum requirements set forth in 21 CFR 165.110(b)]. Specifically, ***
1383	21 CFR 129.35(c)	1	Lockers and lunchrooms	A [locker] [lunchroom] for the employees [is] [are] not [separated from plant operations and storage areas] [equipped with self-closing doors] [equipped with refuse containers] [maintained in a clean and sanitary condition] [free of stored packaging or wrapping material or other processing supplies]. Specifically, ***
1394	21 CFR 129.37(a)	1	Sanitization practices	You do not adequately [clean] [sanitize] the product water-contact surfaces of all [multiservice containers] [utensils] [pipes] [equipment] used in the [transportation] [processing] [handling] [storage] of product water. Specifically, ***
1401	21 CFR 129.37(a)	1	Inspection for sanitary condition	You do not inspect all product water-contact surfaces as often as necessary [to maintain the sanitary condition of such surfaces] [to assure such surfaces are kept free of scale, evidence of oxidation, and other residue]. Specifically, ***
1467	21 CFR 129.40(a)(2)	1	Suitability - contact surfaces	Not all material used for product water contact surfaces [is nontoxic and nonabsorbent] [can be adequately cleaned and sanitized] [is in compliance with section 409 of the Federal Food, Drug and Cosmetic Act]. Specifically, ***
1486	21 CFR 113.87(b)	1	System not established	A system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, ***
1649	21 CFR 113.40(a)(1)	1	Scale and range	The mercury-in-glass thermometer [had divisions not readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale]. Specifically, ***
1652	21 CFR 113.40(a)(1)	1	Defective thermometer	A retort was used without replacing or repairing a mercury-in-glass thermometer [with a divided column] [that could not be adjusted to the standard]. Specifically, ***
1653	21 CFR 113.40(a)(1)	1	Unreadable MIG thermometer	Mercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***
1707	21 CFR 110.80(b)(11)	1	Heat blanching concerns (S)	Failure to minimize thermophilic growth and contamination in blanching operations by the use of [required operating temperatures for the required period of time] [rapid cooling] [the practice of passing the food to the next manufacturing operation without delay] [periodic cleaning]. Specifically, ***
1710	21 CFR 110.80(b)(14)	1	Water activity controls	Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms. Specifically, ***
1715	21 CFR 113.40(a)(10)	1	Air valves, leakage	Failure to supply a suitable air valve for pressure cooling to prevent air leakage into the retort during processing. Specifically, ***
1716	21 CFR 113.40(a)(11)	1	Water valves, leakage	Failure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing. Specifically, ***
1746	21 CFR 113.40(a)(6)	1	Bottom crate supports	Failure to install bottom crate supports in vertical still retorts. Specifically ***
1800	21 CFR 129.80(b)(1)	1	Washing/rinsing/sanitizing	You do not [wash] [rinse] [sanitize] primary service containers by mechanical washers or any other method giving adequate sanitary results. Specifically, ***
1856	21 CFR 113.40(a)(12)	1	Valve type	Failure to install a vent valve which is a gate, plug cock, or other adequate type. Specifically, ***
1961	21 CFR 129.80(g)(3)	1	Proper analytical methods	Bottled drinking water samples are not analyzed by methods approved by the government agency or agencies having jurisdiction. Specifically, ***
1963	21 CFR 129.80(h)	1	Records availability	You did not make all required documents available for official review at reasonable times. Specifically, ***
2102	21 CFR 113.40(a)(13)(i)	1	Maximum weight	The [maximum fill-in weight] [drain weight] specified in the scheduled process is not [measured] [recorded] at intervals of sufficient frequency to ensure that the weight of the product is within limits specified in the scheduled process. Specifically, ***
2142	21 CFR 113.40(b)(1)	1	No MIG thermometer	Failure to install a mercury-in glass thermometer on each retort. Specifically, ***
2146	21 CFR 113.40(b)(1)	1	Unreadable MIG thermometer	Mercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***
2153	21 CFR 113.40(b)(2)	1	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2159	21 CFR 113.40(b)(5)	1	Uniform distribution	Steam is not distributed [in the bottom of the retort] [in a manner adequate to provide uniform heat distribution throughout the retort]. Specifically, ***
2169	21 CFR 113.40(b)(9)	1	Operator check and recording	The operator failed to [check] [record] the water level at intervals sufficient to ensure adequacy of the water level. Specifically, ***
2272	21 CFR 129.80(e)	1	Plant records	You do not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of finished product to wholesale and retail outlets]. Specifically, ***
2285	21 CFR 129.80(f)	1	Reject / reprocess	You did not reject or reprocess containers that were not [sound] [properly capped or sealed] [properly coded and labeled]. Specifically, ***
2320	21 CFR 113.40(c)(2)	1	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2367	21 CFR 129.80(a)	1	Effective treatment	Your treatment of product water is not done in such a manner as to be effective in accomplishing the intended purpose. Specifically, ***
2368	21 CFR 129.80(a)	1	Sec. 409 of the Act	You do not treat product water in accordance with Section 409 of the Federal Food, Drug and Cosmetic Act. Specifically, ***
2390	21 CFR 110.80(a)(6)	1	Kept frozen prior to use	Failure to keep frozen raw materials frozen prior to use. Specifically, ***
2428	21 CFR 110.80(b)(9)	1	Proper reconditioning	Failure to use a proven effective method of reconditioning adulterated food. Specifically, ***
2460	21 CFR 113.40(d)(1)	1	MIG thermometer not used as reference	The mercury-in-glass thermometer was not the reference instrument used for processing temperatures. Specifically, ***
2476	21 CFR 113.40(d)(6)	1	Heat distribution	Heat distribution data or documentary prooffrom the retort manufacturer or process authority was not available to demonstrate that adequate venting is achieved in the retort. Specifically, ***
2494	21 CFR 113.40(e)(1)	1	Thermometer calibration	Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [at least once a year] [as frequently as necessary]. Specifically, ***
2496	21 CFR 113.40(e)(1)	1	Unreadable thermometer	Mercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***
2499	21 CFR 113.40(e)(2)	1	Presence and accuracy	Each retort did not have an accurate temperature-recording device. Specifically, ***
2502	21 CFR 113.40(e)(2)	1	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2507	21 CFR 113.40(e)(5)	1	Recording retort speed	The [rotational speed ] [process time] was not recorded for each retort load processed. Specifically, ***
2537	21 CFR 113.40(f)(2)	1	Corresponding with MIG	Failure to properly adjust the temperature-recording device.The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2581	21 CFR 113.40(c)(10)	1	Measured and recorded	Critical factors were not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
2838	21 CFR 113.40(g)(1)(i)(a)	1	Presence and accuracy	Each product sterilizer does not have a mercury-in glass thermometer (MIG) or equivalent temperature-indicating device. Specifically, ***
2849	21 CFR 113.40(g)(1)(i)(b)	1	Unauthorized adjustment	There is no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
2860	21 CFR 113.40(g)(1)(i)(f)	1	Unauthorized speed changes	There was no means of preventing unauthorized speed changes to the metering pump. Specifically, ***
2870	21 CFR 113.40(g)(1)(ii)(e)	1	Readings with sufficient frequency	Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed][recorded] at intervals of sufficient frequency to ensure the values were as specified in the scheduled process for aseptic packaging operations. Specifically ***
2885	21 CFR 113.40(i)	1	Methods and controls operated and administered for safety	Methods and controls used for the manufacturing, processing and packaging of thermally processed foods wherein critical factors such as water activity are used are not operated and administered in a manner adequate to ensure the product is safe. Specifically, ***
2889	21 CFR 113.40(g)(2)(i)(a)	1	Instrumentation	The [container and closure sterilization system][product filling and closing system] was not instrumented to demonstrate that required sterilization is being accomplished continuously. Specifically, ***
2890	21 CFR 113.40(g)(2)(i)(a)	1	Automatic recording devices	Automatic recording deviceswere not used to record [sterilization media flow rates] [temperature] [concentration] [factors specified in the scheduled process] for container sterilizing, filling, and closing operations. Specifically, ***
2898	21 CFR 113.40(g)(2)(ii)(c)	1	Sufficient frequency	Observations and measurements of operating conditions were not [made] [recorded] at intervals of sufficient frequency to ensure commercial sterility. Specifically, ***
2899	21 CFR 113.40(g)(2)(ii)(c)	1	Required information	Observations and measurements of operating conditions did not include [sterilization media flow rates] [temperatures] [container and closure rates through the sterilizing system] [batch container sterilization conditions]. Specifically, ***
2901	21 CFR 113.40(i)	1	Critical factors	Critical factors are not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
3068	21 CFR 114.80(a)(1)	1	pH control	Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain]a pH value of 4.6 or lower in all finished foods. Specifically,***
3768	21 CFR 113.40(a)(3)	1	Pressure gauges (S)	Failure to provide a pressure gauge graduated in divisions of 2 pounds or less for each retort. Specifically, ***
3770	21 CFR 113.40(a)(7)	1	Length of steam spreader, horizontal retort	Failure of the steam spreader to extend the full length of the horizontal still retort(s). Specifically, ***
3773	21 CFR 113.40(a)(7)	1	Number and size of steam spreader perforations (S)	The total cross-sectional area of steam spreader perforations is [less than 1 1/2] [greater than 2] times the cross-sectional area of the smallest restriction in a steam inlet line. Specifically, ***
3775	21 CFR 113.40(a)(9)	1	Size of perforations in sheet metal bottoms and dividers (S)	Perforated sheet metal used as [the bottom] [dividers] in retort crates or baskets fails to have perforations approximately equivalent to 1-inch holes on 2-inch centers. Specifically, ***
3800	21 CFR 113.40(a)(1)	1	Date last tested for accuracy (S)	Failure to provide a tag, seal, or other means of identity, including the date of last calibration of the mercury-in-glass thermometer. Specifically, ***
3848	21 CFR 113.40(g)(4)	1	Frequency of critical factor monitoring (S)	Failure to [measure] [record] critical factors specified in the scheduled process at intervals of fifteen minutes or less. Specifically, ***
3858	21 CFR 113.60(a)	1	Observation of specific gross defects (S)	For visual examination of double-seam cans, each can from each seaming head was not examined for [cutover or sharpness] [skidding or deadheading] [false seam] [droop at the crossover or lap] [condition of inside of countersink wall for evidence of broken chuck]. Specifically, ***
3862	21 CFR 113.60(a)(1)	1	Failure to perform teardown examinations	Failure to [have a qualified individual] perform teardown examinations of double seam cans . Specifically, ***
3865	21 CFR 113.60(a)(1)	1	Corrective actions following teardown examinations	Failure to note corrective actions taken following teardown examination of double seam cans. Specifically, ***
3866	21 CFR 113.60(a)(1)(i)(a)	1	Required can seam measurements (micrometer)	Records of the results of micrometer measurements of double seam cans fail to include [cover hook] [body hook] [width] [tightness] [thickness]. Specifically, ***
3885	21 CFR 113.87(c)	1	IT of cans in water filled retorts	Failure to assure that the initial temperature of cans exposed to water during filling or operating of the retort was not lower than the initial temperature specified in the scheduled process. Specifically, ***
3886	21 CFR 113.87(e)	1	Clock time agreement with time of day (S)	Failure of the clock times indicated on recording-temperature charts to reasonably correspond to the time of day on the written processing records. Specifically, ***
3892	21 CFR 113.60(a)	1	Regular observations for gross closure defects	Failure to make regular observations for gross closure defects during production runs. Specifically ***
4065	21 CFR 113.40(a)(12)	1	Vent valve not open	Failure to fully open the vent valve during the venting period. Specifically, ***
4067	21 CFR 113.40(a)(12)(iii)	1	Venting, other installations	Failure to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, for retort installations which deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)] [113.40(a)(12)(ii)(b)]. Specifically, ***
4068	21 CFR 113.40(a)(4)	1	Maintenance of steam-actuated controller	Failure to carefully maintain mechanically a steam-activated retort steam controller. Specifically, ***
4069	21 CFR 113.40(b)(13)	1	Retort configuration	Failure to have data on file which demonstrates that the heat distribution is adequate for retort installations which deviate from the diagrams in 21 CFR 113.40(b)(13). Specifically, ***
4176	21 CFR 113.81(b)	1	Minimize thermophilic growth (S)	Failure to use adequate operating temperatures and cleaning procedures to minimize thermophilic growth. Specifically, III
4420	21 CFR 110.110(c)	1	Defects not reduced to lowest level	Quality control operations were not used at all times to reduce natural or unavoidable defects to the lowest level currently feasible
4520	21 CFR 108.35(c)(3)(ii)	1	Process information availability	Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, ***
4525	21 CFR 108.35(h)	1	Record retention	Failure to prepare, review and retain at the [processing plant] [a reasonably accessible location] for three years, all records [of processing] [of deviations in processing] [of container closure inspections] [specified in Part 113]. Specifically, ***
4526	21 CFR 108.35(h)	1	Record inspection and copying	Failure to permit [inspection] [copying] of records [of processing] [of deviations in processing] [of container closure inspections] [specified in 21 CFR 113], upon written demand by FDA, to verify the adequacy of processing, the integrity of container closure and the coding of the product. Specifically, ***
6011	21 CFR 123.8(a)(3)(ii)	1	Corrective action record review adequacy	Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken]. Specifically, ***
9926	21 CFR 120.14(a)	1	Importer - written procedures	You do not have written procedures that describe [product specifications] [affirmative steps] to ensure that juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, ***
9929	21 CFR 120.12(b)(4)	1	Records - information not entered when observed	Processing and other information is not [always] entered on your records at the time it is observed. Specifically, ***
9962	21 CFR 120.24(b)	1	Process controls - direct treatment- not exempt	Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply. Specifically, ***
9969	21 CFR 120.25(a)	1	Process verification - sample size	You did not [randomly] take the required samples for Escherichia coli testing for the amount of juice produced [from finished consumer packages]. Specifically, ***
12702	21 CFR 129.37(a)	1	Remedy unsanitary condition	You did not remedy the presence of unsanitary conditions, scale, residue, or oxidation on a product water-contact surface by adequate cleaning and sanitizing prior to use. Specifically, ***
12703	21 CFR 129.80(a)	1	Product samples	You do not take product water samples after processing and prior to bottling. Specifically, ***
15310	21 CFR 70.25	1	Color additive labeling	Color additive was not labeled with [the name of the straight color] [the name of each ingredient comprisingthe color additive] [a statement indicating general limitations for use] [the amount of each straight color in terms of weight per unit/volume or percent by weight] [an expiration date]. Specifically, ***
15385	21 CFR 111.10(a)(2)	1	Personnel - health condition - supervisor notification	You did not instruct your employees to notify their supervisor if they have or if there is a reasonable possibility that they have a health condition that could result in microbial contamination of components, dietary supplements, or contact surfaces. Specifically, ***
15389	21 CFR 111.10(b)(1)	1	Outer garments	Your personnel did not wear outer garments in a manner that protects against contamination of components, dietary supplements or contact surfaces. Specifically, ***
15395	21 CFR 111.10(b)(5)	1	Gloves	Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material]. Specifically, ***
15406	21 CFR 111.13(b)	1	Supervisor - education, training	Each supervisor you use is not qualified by education, training, or experience to supervise. Specifically, ***
15445	21 CFR 111.15(c)(1)	1	Sanitizing agents	You did not use sanitizing agents that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use]. Specifically, ***
15446	21 CFR 111.15(c)(2)	1	Toxic materials - use	You [used] [held] toxic materials in your physical plant that were not necessary to maintain clean and sanitary conditions, for use in laboratory testing procedures, for maintaining or operating your physical plant or equipment, or for use in your plant's operations. Specifically, ***
15449	21 CFR 111.15(f)(2)	1	Plumbing - sewage, liquid waste	The plumbing in your physical plant was not adequate to properly convey sewage and liquid disposable waste from your physical plant. Specifically, ***
15455	21 CFR 111.20(a)	1	Physical plant - size, construction, design	Your physical plant was not suitable in size, construction, design to facilitate [maintenance] [cleaning] [sanitizing] operations. Specifically, ***
15456	21 CFR 111.20(b)	1	Physical plant - space; equipment, materials	Your physical plant did not have adequate space for the orderly placement of equipment and holding of materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination and mix-ups of components and dietary supplements]. Specifically, ***
15461	21 CFR 111.20(d)(1)(iii)	1	Physical plant - ventilation, environmental control	Your physical plant did not have [adequate ventilation] [environmental control equipment] to minimize odors and vapors in areas where they may contaminate components, dietary supplements, or contact surfaces. Specifically, ***
15480	21 CFR 111.20(h)	1	Physical plant - screening against pests	Your physical plant did not use adequate screening or other protection against pests. Specifically, ***
15501	21 CFR 111.27(a)(3)(i)	1	Equipment - installed to facilitate cleaning	Your equipment or utensils were not [installed] [maintained] to facilitate cleaning of [the equipment] [the utensils] [all adjacent spaces]. Specifically, ***
15506	21 CFR 111.27(a)(4)	1	Equipment - bonded seams	You used equipment or utensils that do not have seams that are smoothly bonded or maintained to minimize accumulation of extraneous materials or contaminants. Specifically, ***
15509	21 CFR 111.27(a)(6)	1	Instruments, controls - accurate, precise, maintained	You used instruments or controls that were not [accurate and precise] [adequately maintained] [adequate in number for their designated uses]. Specifically, ***
15511	21 CFR 111.27(d)	1	Equipment - maintain - general	You did not [maintain] [clean] [sanitize]equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
15518	21 CFR 111.27(d)(4)	1	Contact surfaces - not in direct contact - cleaning	You did not clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements. Specifically, ***
15527	21 CFR 111.30(c)	1	Equipment - automated - QC check	Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of your automated, mechanical, or electronic equipment. Specifically, ***
15535	21 CFR 111.255(d)	1	Batch record - 1 year, 2 years	You did not keep batch production records for the required time period. Specifically, ***
15548	21 CFR 111.260(h)	1	Batch record - results; testing, examination; batch	Your batch production records did not include the results of testing or examination performed during batch production, or a cross-reference to such results. Specifically, ***
15553	21 CFR 111.260(j)(2)(i)	1	Batch record - initials; weighing	Your batch production records did not include the initials of the person responsible for weighing or measuring each component used in the batch. Specifically, ***
15555	21 CFR 111.260(j)(2)(iii)	1	Batch record - initials; component	Your batch production records did not include the initials of the person responsible for adding a component to the batch. Specifically, ***
15558	21 CFR 111.260(k)(1)	1	Batch record - identifier; packaging	Your batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used]. Specifically, ***
15569	21 CFR 111.260(n)	1	Batch record - reprocessing	Your batch production records did not include documentation of reprocessing. Specifically, ***
15575	21 CFR 111.153	1	Written procedures - rejected products	You did not [establish] [follow] written procedures for the requirements for rejected products that are received for packaging or labeling as a dietary supplement. Specifically, ***
15577	21 CFR 111.155(b)	1	Visually examine - supplier's invoice	You did not visually examine the supplier's invoice, guarantee, or certification in [a shipment] [shipments] you received to ensure the components are consistent with your purchase order. Specifically, ***
15579	21 CFR 111.155(c)(1)	1	Components - representative samples	You did not collect representative samples of components while the components were quarantined. Specifically, ***
15581	21 CFR 111.155(c)(3)	1	Quality control - components, approve, release	Your quality control personnel did not [approve components while the components were quarantined] [release components from quarantine] for use in the manufacture of a dietary supplement. Specifically, ***
15585	21 CFR 111.155(d)(2)	1	Components - unique identifier	You did not use a unique identifier whenever you recorded the disposition of [each unique lot within each unique shipment of components that you received] [each lot of components that you produced]. Specifically, ***
15587	21 CFR 111.160(a)	1	Packaging, labels - visually examine container	You did not visually examine each immediate container, or grouping of immediate containers, in a shipment for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the packaging and labels. Specifically, ***
15588	21 CFR 111.160(b)	1	Packaging, labels - visually examine; invoice, guarantee	You did not visually examine the supplier's invoice, guarantee, or certification in a shipment to ensure that the packaging or labels are consistent with your purchase order. Specifically, ***
15598	21 CFR 111.160(d)(1)	1	Packaging - identify	You did not identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the packaging] [the dietary supplement that you distributed]. Specifically, ***
15610	21 CFR 111.165(d)(1)	1	Product received - identify	You did not identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the status of the received product] [the product that you packaged or labeled and distributed as a dietary supplement]. Specifically, ***
15611	21 CFR 111.165(d)(2)	1	Product received - unique identifier, disposition	You did not use a unique identifier when you recorded the disposition of a unique lot within a unique shipment of received product. Specifically, ***
15614	21 CFR 111.170	1	Quarantinecomponent, package, labels, rejected product	You did not clearly identify, hold, and control under a quarantine system for appropriate disposition [a component] [packaging] [labels] [product] that you received for packaging or labeling as a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations. Specifically, ***
15617	21 CFR 111.180(a)	1	Records - comp, package, labels, product received: Available	You did not have records or copies of records required for [components] [packaging] [labels] [product received for packaging or labeling] readily available during the required retention period for inspection and copying by FDA when requested. Specifically, ***
15618	21 CFR 111.180(b)(1)	1	Written procedures - components	You did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements. Specifically,***
15627	21 CFR 111.180(b)(3)	1	Documentation - product received; packaging, labeling	You did not make and keep documentation that the requirements that apply to production and process control for product received for packaging or labeling as a dietary supplement were met. Specifically, ***
15628	21 CFR 111.180(b)(3)	1	Documentation - rejected components, packaging, labels	You did not make and keep documentation that the requirements that apply to production and process control for rejected components, packaging, or labels were met. Specifically, ***
15631	21 CFR 111.180(b)(3)(ii)(A)	1	Documentation - required operation; date received	Your documentation of a required operation did not include the date that [components] [packaging] [labels] [products received for packaging or labeling as a dietary supplement] were received. Specifically, ***
15632	21 CFR 111.180(b)(3)(ii)(B)	1	Documentation - required operation; initials	Your documentation of a required operation did not include the initials of the person performing the required operation. Specifically, ***
15652	21 CFR 111.465(b)	1	Retain reserve samples - 1 year, 2 years	You did not retain reserve samples for the required time. Specifically, ***
15669	21 CFR 111.310(c)	1	Laboratory facilities -dietary supplement specifications	You did not use adequate laboratory facilities to perform [testing] [examinations] necessary to determine whether your dietary supplements met specifications. Specifically, ***
15671	21 CFR 111.315	1	Laboratory controlprocesses - requirements	You did not [establish] [follow] laboratory control processes. Specifically, ***
15677	21 CFR 111.315(b)(1)	1	Sampling plans; components	You did not [establish] [follow] sampling plans for obtaining representative samples of components. Specifically, ***
15679	21 CFR 111.315(b)(1)	1	Laboratory controlprocesses - sampling plans; packaging	You did not [establish] [follow] sampling plans for obtaining representative samples of packaging. Specifically, ***
15684	21 CFR 111.315(b)(5)	1	Sampling plans; packaged, labeled dietary supplement, QC	The sampling plan you used for obtaining representative samples of packaged and labeled dietary supplements was not reviewed and approved by quality control personnel. Specifically, ***
15687	21 CFR 111.315(b)(4)	1	Sampling plans; product for packaging, labeling	You did not [establish] [follow] sampling plans for obtaining representative samples of product that you received for packaging or labeling as a dietary supplement. Specifically, ***
15691	21 CFR 111.315(b)(2)	1	Sampling plans; in-process materials	You did not [establish] [follow] sampling plans for obtaining representative samples of in-process materials. Specifically, ***
15693	21 CFR 111.315(b)(1)	1	Laboratory controlprocesses - sampling plans; labeling	You did not [establish] [follow] sampling plans for obtaining representative samples of labels. Specifically, ***
15695	21 CFR 111.315(e)	1	Examination, testing; established criteria, quality control	Your laboratory control processes for use of test methods and examinations in accordance with established criteria were not reviewed and approved by quality control personnel. Specifically, ***
15709	21 CFR 111.325(b)(2)	1	Laboratory methodology followed	You did not make and keep documentation that established laboratory methodology was followed. Specifically, ***
15712	21 CFR 111.325(b)(2)(ii)	1	Records - document; results	The documentation for laboratory tests and examinations did not include the results of the testing and examination. Specifically, ***
15718	21 CFR 111.375(a)	1	Records-manufacturing operation:originals,copies,electronic	You did not keep the records required for manufacturing operations as original records, true copies, or as electronic records. Specifically, ***
15720	21 CFR 111.370	1	Rejected dietary supplements - identify, hold, control	You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations. Specifically,
15721	21 CFR 111.365(k)	1	Processing lines, major equipment - contents	You did not identify [processing lines] [major equipment] used during manufacturing to indicate their contents. Specifically, ***
15739	21 CFR 111.210(h)(3)(ii)(B)	1	Components; add, verify	The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person to add and another person to verify the addition of the components. Specifically, ***
15752	21 CFR 111.210(c)	1	Master manufacturing record - components; weight, measure	Your master manufacturing record did not include an accurate weight or measure of each component to be used. Specifically, ***
15755	21 CFR 111.205(c)	1	Master manufacturing record:readily available	You did not have records or copies of records required for your master manufacturing records readily available during the required retention period for inspection and copying by FDA when requested. Specifically, ***
15756	21 CFR 111.205(c)	1	Master manufacturing record:electronic	Your electronic master manufacturing records do not comply with the electronic records requirements. Specifically, ***
15758	21 CFR 111.205(c)	1	Master manufacturing record: 1 year, 2 years	You did not keep a master manufacturing record for the required time period. Specifically, ***
15771	21 CFR 111.415(h)	1	Obsolete labels, packaging - dispose	You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations. Specifically, ***
15774	21 CFR 111.415(f)(1)	1	Batch-lot,control number packaged, labeled dietary supplemen	You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement. Specifically, ***
15777	21 CFR 111.415(c)	1	Filling, assembling, packaging, labeling - sanitary handling	You did not use sanitary handling procedures during [filling] [assembling] [packaging] [labeling] operations. Specifically, ***
15780	21 CFR 111.415	1	Fill, assemble, package, label - master record	You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
15788	21 CFR 111.410(a)	1	Packaging - specifications	You did not take necessary actions to determine whether packaging for dietary supplements meets specifications so that the condition of the packaging will ensure the quality of your dietary supplements. Specifically, ***
15803	21 CFR 111.560?	1	Product complaint -investigate, findings, followup	Your [review about whether to investigate a product complaint] [findings and follow-up action of an investigation performed] did not extend to all relevant batches and records. Specifically, ***
15807	21 CFR 111.570(a)	1	Records - product complaints: electronic	Your electronic records for product complaints do not comply with the electronic records requirements. Specifically,***
15813	21 CFR 111.570(b)(2)(ii)(B)	1	Record - product complaint; batch, lot, control number	The written record of a product complaint did not include the batch, lot, or control number of the dietary supplement. Specifically, ***
15816	21 CFR 111.570(b)(2)(ii)(E)	1	Record - product complaint; reply	The written record of a product complaint did not include the reply to the complainant. Specifically, ***
15823	21 CFR 111.60(b)	1	Production, in-process control system review, approved	Your production and in-process control system was not reviewed and approved by quality control personnel. Specifically, ***
15831	21 CFR 111.70(b)(3)	1	Specifications - contamination limits	You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, ***
15833	21 CFR 111.70(c)(1)	1	Specifications - in-process contamination limits	You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically,***
15847	21 CFR 111.73	1	Specifications met - component identity	You did not determine whether you met identity specifications established for components. Specifically, ***
15848	21 CFR 111.73	1	Specifications met - component purity, strength, composition	You did not determine whether you met established component specifications established to ensure the [purity] [strength] [composition] of dietary supplements manufactured using the components. Specifically,***
15850	21 CFR 111.73	1	Specifications metin-process purity, strength, composition	You did not determine whether you met in-process specifications to ensure the [purity] [strength] [composition] of the dietary supplements. Specifically, ***
15860	21 CFR 111.75(a)(2)	1	Component - confirm identity; specifications met	You did not confirm the identity of components. Specifically, ***
15865	21 CFR 111.75(a)(2)(ii)(D)	1	Re-confirm certificate of analysis	You did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, ***
15867	21 CFR 111.75(b)(1)	1	Specifications met, in-process - quality finished batch	You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met. Specifically, ***
15868	21 CFR 111.75(b)(2)	1	Specifications met - deviation, unanticipated occurrence	You did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated occurrence that may result in a failure to meet specifications. Specifically, ***
15874	21 CFR 111.75(c)(4)	1	Documentation - specifications met; basis, quality control	Your quality control personnel did not review and approve your documentation of the basis for determining compliance with [an] established specification[s] for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]. Specifically, ***
15875	21 CFR 111.75(d)(1)	1	Documentation specifications met; exempted, periodic testing	You did not document why an exempted product specification is met without verification by periodically testing the finished batch. Specifically, ***
15881	21 CFR 111.75(g)	1	Packaging, labeling - visual examination	You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label. Specifically, ***
15883	21 CFR 111.75(i)	1	Corrective action plan	You did not establish a corrective action plan to use when an established specification is not met. Specifically, ***
15886	21 CFR 111.77(b)	1	Specifications not met - identity; component, reject	Your quality control personnel did not reject a component that did not meet an identity specification. Specifically,***
15890	21 CFR 111.80(a)	1	Components packaging, labels used	You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you used to determine whether the [components] [packaging] [labels] meet[s] established specifications. Specifically, ***
15892	21 CFR 111.80(b)	1	Specifications - representative samples; in-process material	You did not collect representative samples of in-process materials for each manufactured batch as specified in the master manufacturing record to determine whether the in-process materials met established specifications. Specifically, ***
15894	21 CFR 111.80(d)	1	Specifications - representative samples; unique lot	You did not collect representative samples of [each unique shipment] [each unique lot within each unique shipment] product that you received for packaging or labeling as a dietary supplement to determine whether the received product meets established specifications. Specifically, ***
15903	21 CFR 111.87	1	Material review, disposition - quality control	Your quality control personnel did not [conduct required material reviews] [make required disposition decisions]. Specifically,
15905	21 CFR 111.90(a)(1)	1	Reprocessed - rejected dietary supplement	You reprocessed a rejected dietary supplement for which quality control personnel did not conduct a material review and make a disposition decision to approve the reprocessing. Specifically, ***
15911	21 CFR 111.90(b)(1)	1	In-process adjustment, component - no material review	You made an in-process adjustment to a component of a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the in-process adjustment]. Specifically, ***
15912	21 CFR 111.90(c)	1	Reprocessed batch - quality control approve	Your quality control personnel did not approve a batch of dietary supplement that was reprocessed. Specifically, ***
15934	21 CFR 111.105(c)	1	Basis; in-process, component, specifications	Your quality control personnel did not review and approve the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met. Specifically, ***
15939	21 CFR 111.105(g)	1	Quality control - reserve samples	Your quality control personnel did not ensure that required reserve samples were collected and held. Specifically, ***
15941	21 CFR 111.105(i)	1	QC required operations production and process control	Your quality control personnel did not perform required operations for the production and process control system. Specifically, ***
15949	21 CFR 111.110(a)	1	QC-Laboratory control processes; production, process control	Your quality control operations did not include reviewing and approving laboratory control processes associated with the production and process control system. Specifically, ***
15950	21 CFR 111.110(b)	1	Quality control operations - tests, examinations	Your quality control operations did not include ensuring that [tests] [examinations] required for your laboratory operations were conducted. Specifically, ***
15951	21 CFR 111.110(c)	1	Quality control operations - tests, examinations; results	Your quality control operations did not include reviewing and approving the results of required [tests] [examinations]. Specifically, ***
15952	21 CFR 111.113	1	Quality control operations - material review, disposition	You do not have quality control operations for a material review and disposition decision. Specifically, ***
15954	21 CFR 111.113(a)(2)	1	QC master manufacturing record; material review, disposition	Your quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record. Specifically, ***
15960	21 CFR 111.113(b)(1)	1	Quality control - dietary supplement; adulteration	Your quality control personnel did not reject the dietary supplement when there was a deviation or unanticipated occurrence during the production and in-process control system that [resulted in] [could lead to] adulteration of the dietary supplement. Specifically, ***
15968	21 CFR 111.117(c)	1	Quality control operations - equipment records	Your quality control operations did not include periodically reviewing all records for calibrations, inspections, or checks of [automated equipment] [mechanical equipment] [electronic equipment]. Specifically, ***
15976	21 CFR 111.123	1	Quality control operations - master, batch, manufacturing	You do not have quality control operations requiredfor the [master manufacturing record] [batch production record] [manufacturing operations]. Specifically, ***
15978	21 CFR 111.123(a)(2)	1	Quality control operations - batch production records	Your quality control operations did not include reviewing and approving all batch production-related records. Specifically, ***
15983	21 CFR 111.123(a)(7)	1	Quality control operations - finished batch, specifications	Your quality control operations did not include determining whether each finished batch conforms to established product specifications. Specifically, ***
15985	21 CFR 111.123(b)(1)	1	Quality control - components, identity specifications	Your quality control personnel approved and released for distribution a batch of dietary supplement for which one or more components did not meet identity specifications. Specifically, ***
15992	21 CFR 111.127(b)	1	Quality control operations - packaging; quarantine	Your quality control operations for packaging did not include approving and releasing from quarantine, prior to use, products you receive for packaging. Specifically, ***
15995	21 CFR 111.127(d)	1	QC operations - packaged, labeled; specifications	Your quality control operations did not include determining whether the finished [packaged] [labeled] dietary supplement conforms to established specifications. Specifically, ***
15999	21 CFR 111.127(h)	1	QC operations - packaging, labeling; approving, rejecting	Your quality control operations for packaging and labeling did not include approving for release, or rejecting, any packaged and labeled dietary supplement. Specifically, ***
16008	21 CFR 111.135	1	Quality control operations - product complaints; investigate	Your quality control operations for product complaints did not include [reviewing and approving decisions about whether to investigate a product complaint] [reviewing and approving the findings and follow-up action of any investigation performed]. Specifically, ***
16015	21 CFR 111.140(b)(2)(i)	1	Records - date; review, approval, rejection	Your written documentation that quality control personnel reviewed, approved, or rejected reprocessing did not include the date that the review, approval, or rejection was performed. Specifically, ***
16022	21 CFR 111.140(b)(3)(iv)	1	Material review, disposition, follow-up; identification	Your documentation of your material review and disposition decision and follow-up did not include identification of the action taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence. Specifically, ***
16043	21 CFR 111.503	1	Written procedures - returned dietary supplement; destroyed	You did not [establish] [follow] written procedures for when a returned dietary supplement must be destroyed, or otherwise suitably disposed. Specifically, ***
16046	21 CFR 111.503	1	Written procedures returned dietary supplement investigation	You did not [establish] [follow] written procedures for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement. Specifically, ***
16047	21 CFR 111.510	1	Returned dietary supplement - material review, disposition	You did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision. Specifically, ***
16048	21 CFR 111.515	1	Returned dietary supplement - destroyed	You did not destroy, or otherwise suitably dispose of, a returned dietary supplement not approved for salvaging and redistribution or not approved for reprocessing. Specifically, ***
16059	21 CFR 111.535(b)(3)	1	Returned dietary supplement: results; testing, examination	You did not make and keep records of the results of testing or examination conducted to determine compliance with established product specifications. Specifically, ***
16067	21 CFR 111.35(b)(1)(ii)	1	Procedures - equipment; calibrating, inspecting, checking	You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated, mechanical, or electronic equipment. Specifically, ***
16068	21 CFR 111.35(b)(1)(iii)	1	Equipment, utensils; maintaining, cleaning, sanitizing	You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and utensils that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
16069	21 CFR 111.35(b)(1)(iii)	1	Procedures contact surfaces; maintaining, cleaning,sanitize	You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, ***
16072	21 CFR 111.35(b)(3)	1	Instruments, controls; calibrate date, reference std, method	Your calibration documentation did not [identify the instrument or control calibrated] [provide the date of calibration] [identify the reference standard used] [include the certification of accuracy of the known reference standard] [include a history of recertification of accuracy of a known reference standard] [identify the calibration method used] [include appropriate limits for accuracy and precision] [provide the calibration reading or readings found] [identify the recalibration method used] [identify the reading or readings of recalibration found if the accuracy or precision limits were not met] [include the initials of the person who performed the calibration or recalibration]. Specifically, ***
16085	21 CFR 111.75(c)(3)	1	Specifications met limits on contamination ; basis	You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for the limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement will ensure that the finished batch of dietary supplement will not be adulterated as a result of such contamination. Specifically, ***
16144	21 CFR 118.4(d)	1	Before new laying hens added	Your poultry house was not cleaned and disinfected by appropriate procedures before new laying hens were added to the house, when there was [an environmental test] [an egg test] that was positive for SE at any point during the life of a flock that was housed there prior to depopulation. Specifically,***
16153	21 CFR 118.5(a)(1)	1	Poultry house has multiple groups of laying hens	Environmental testing for SE, using approved methods,was not done in a poultry house containing more than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age. Specifically,***
16158	21 CFR 118.5(b)(2)(ii)	1	Positive test 4 to 6 weeks-begin egg testing	An environmental test was positive for SE 4 to 6 weeks after the end of a molting process, and the eggs were not diverted to treatment, but you did not begin egg testing within 10 calendar days of receiving notification of the positive environmental test. Specifically,***
16159	21 CFR 118.5(b)(2)(i)	1	Positive test 4 to 6 weeks-review and adjust	An environmental test at 4 to 6 weeks after the end of a molting process was positive, but you did not review and make any necessary adjustments to your SE prevention plan to ensure that all measures were being properly implemented. Specifically,***
16164	21 CFR 118.6(c)	1	Four egg tests, flock in positive poultry house	You were required to perform egg testing, but you did not conducted egg testing on the eggs from a flock in an SE positive poultry house [using egg sampling and testing methodology specified in the Code of Federal Regulations] [at two week intervals]. Specifically,***
16165	21 CFR 118.6(d)	1	Any of 4 egg tests positive for SE	One or more of 4 egg test samples taken from a flock in a poultry house positive for SE was positive for SE, and you failed to [divert all eggs from that flock to treatment after receiving notification of an SE-positive egg test] [continue diversion of all eggs from that flock for treatment until four egg tests using appropriate sampling and methodology at two week intervals were negative for SE]. Specifically,***
16209	21 CFR 118.11(a)	1	Registration within 30 days	Your firm did not register your farm(s) with the FDA [within 30 days of becoming an egg producer] [by the applicable effective date of the regulation (21 CFR Part 118)]. Specifically,***
16228	21 CFR 118.11(e)(2)	1	Number of layers and houses	You did not submit through your registration process, [the average or usual number of layers of each house] [the number of poultry houses] on the farm. Specifically,***

Devices

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Devices	3130	21 CFR 820.100(a)	338	Lack of or inadequate procedures	Procedures for corrective and preventive action have not been [adequately] established. Specifcally, ***
	14713	21 CFR 820.198(a)	252	Lack of or inadequate complaint procedures	Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,***
	630	21 CFR 803.17	138	Lack of Written MDR Procedures	Written MDR procedures have not been [developed] [maintained] [implemented]. Specifcally, ***
	3696	21 CFR 820.100(b)	133	Documentation	Corrective and preventive action activities and/or results have not been [adequately] documented. Specifcally, ***
	546	21 CFR 820.75(a)	116	Lack of or inadequate process validation	A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifcally, ***
	3331	21 CFR 820.181	104	DMR - not or inadequately maintained	A device master record has not been [adequately] maintained. Specifically, ***
	479	21 CFR 820.50	98	Purchasing controls, Lack of or inadequate procedures	Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifcally, ***
	3282	21 CFR 820.90(a)	91	Nonconforming product, Lack of or inadequate procedures	Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***
	3103	21 CFR 820.30(i)	81	Design changes - Lack of or Inadequate Procedures	Procedures for design change have not been [adequately] established. Specifically,***
	2327	21 CFR 820.22	80	Quality audits - Lack of or inadequate procedures	Procedures for quality audits have not been [adequately] established.
	3172	21 CFR 820.198(c)	78	Investigation of device failures	Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
	2350	21 CFR 820.25(b)	64	Training - Lack of or inadequate procedures	Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***
	3680	21 CFR 820.70(a)	63	Process control procedures, Lack of or inadequate procedures	Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established. Specifically, ***
	3168	21 CFR 820.198(a)	62	Complaints	Complaint files are not [adequately] maintained. Specifically ***
	3125	21 CFR 820.80(d)	59	Lack of or inadequate final acceptance procedures	Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
	2371	21 CFR 820.30(a)	58	Design control - no procedures	Procedures for design control have not been established. Specifically,***
	3159	21 CFR 820.184	56	DHR content	The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
	3666	21 CFR 820.20(c)	56	Management review - Lack of or inadequate procedures	Procedures for management review have not been [adequately] established. Specifically,***
	3837	21 CFR 820.25(b)	56	Training records	Personnel training is not documented. Specifically, ***
	732	21 CFR 803.50(a)(2)	55	Report of Malfunction	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
	14712	21 CFR 820.184	55	DHR - not or inadequately maintained	A device history record has not been [adequately] maintained. Specifically, ***
	447	21 CFR 820.40	54	Lack of procedures, or not maintained	Document control procedures have not been [established] [maintained]. Specifically,***
	3233	21 CFR 820.72(a)	54	Calibration, Inspection, etc. Procedures Lack of or Inadequ	Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifcally, ***
	3121	21 CFR 820.80(b)	53	Lack of or inadequate receiving acceptance procedures	Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
	3160	21 CFR 820.184	53	Lack of or inadequate DHR procedures	Procedures for device history records have not been [adequately] established. Specifically,***
	3415	21 CFR 820.22	50	Quality Audit/Reaudit - conducted	Quality [audits][reaudits] have not been performed. Specifically, ***
	3118	21 CFR 820.75(a)	45	Documentation	Process validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved]. Specifically, ***
	3375	21 CFR 820.198(e)	44	Records of complaint investigation	Records of complaint investigations do not include required information. Specifically, ***
	14722	21 CFR 820.40	44	Procedures not adequately established or maintained	Document control procedures have not been adequately [established] [maintained]. Specifically,***
	731	21 CFR 803.50(a)(1)	41	Report of Death or Serious Injury	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury. Specifically, ***
	3127	21 CFR 820.80(e)	41	Documentation	Acceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
	3669	21 CFR 820.20(c)	41	Management review - defined interval, sufficient frequency	Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency]. Specifcally, ***
	3128	21 CFR 820.90(a)	40	Nonconforming product control	Products that do not conform to specifications are not adequately controlled. Specifically, ***
	3104	21 CFR 820.30(j)	39	Design history file	The design history file [was not established] [does not demonstrate that the design was developed following the approved design plan] [does not demonstrate that the design was developed following the requirements of 21 CFR 820].
	3120	21 CFR 820.80(a)	38	Lack of or inadequate procedures - Acceptance activities	Procedures for acceptance activities have not been [adequately] established. Specifically,***
	541	21 CFR 820.70(c)	36	Environmental control Lack of or inadequate procedures	Procedures to control environmental conditions have not been [adequately] established. Specifically, ***
	3101	21 CFR 820.30(g)	36	Design validation- Lack of or inadequate procedures	Procedures for design validation have not been [adequately] established. Specifically,***
	4059	21 CFR 820.22	35	Quality Audits - defined intervals	Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether the quality system activities and results comply with quality system procedures. Specifically, ***
	486	21 CFR 820.50(a)	34	Evaluation of suppliers, contractors, etc., requirements	Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, ***
	3678	21 CFR 820.30(g)	34	Design Validation - Risk analysis not performed/inadequate	Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
	537	21 CFR 820.70(a)	32	Production processes	Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications. Specifically, ***
	2974	21 CFR 812.110(b)	31	Investigator non-compliance with agreement/plan/regulations	An investigation was not conducted in accordance with [the signed agreement] [the investigational plan] [applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed by FDA]. Specifically, ***
	3207	21 CFR 820.50(b)	31	Supplier notification of changes	There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, ***
	419	21 CFR 820.20(b)	30	Lack of or inadequate organizational structure	The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820. Specifically, ***
	2302	21 CFR 820.20(e)	30	Quality System Procedures	Quality system procedures and instructions have not been established. Specifically,***
	3226	21 CFR 820.70(g)(1)	30	Maintenance schedule, Lack of or inadequate schedule	Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, ***
	2328	21 CFR 820.22	29	Quality audits - auditor independence	Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
	3170	21 CFR 820.198(b)	29	Review and evaluation for investigation	Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
	3123	21 CFR 820.80(c)	26	Lack of or inadequate In-process acceptance procedures	Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
	3286	21 CFR 820.90(b)(1)	26	Procedures for product review,disposition lack of/inadequate	Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established. Specifically, ***
	14716	21 CFR 820.30(f)	26	Design verification - output does not meet input requirement	Design verification does not confirm that design output meets design input requirements. Specifically, ***
	539	21 CFR 820.70(b)	25	Production and Process Change Procedures, lack of or Inad.	Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, ***
	3192	21 CFR 820.30(g)	25	Design validation - user needs and intended uses	Design validation did not ensure the device conforms to defined user needs and intended uses. Specifically, ***
	14720	21 CFR 820.50(a)(3)	25	Acceptable supplier records, inadequate records	Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
	3285	21 CFR 820.90(b)(2)	24	Product rework procedures, Lack of or inadequate procedures	Procedures for rework of nonconforming product have not been [adequately] established. Specifically, ***
	4191	21 CFR 806.10(a)(1)	24	Report of risk to health	A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Specifically, ***
	2430	21 CFR 820.30(b)	23	Design plans - Lack of or inadequate	Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established. Specifically, ***
	2604	21 CFR 820.30(e)	23	Design review - Lack of or inadequate procedures	Procedures for design review have not been [adequately] established. Specifically,***
	14710	21 CFR 820.150	23	Lack of or inadequate procedures for storage.	Procedures for the control of storage areas and stock rooms have not been [adequately] established. Specifically,***
	631	21 CFR 803.17(a)(1)	22	Lack of System for Event Evaluations	The written MDR Procedure does not include an internal system which provides for the timely and effective [identification] [communication] [evaluation] of events that may be subject to medical device reporting requirements. Specifcally, ***
	3345	21 CFR 820.200(a)	22	Servicing - Lack of or inadequate procedures	Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
	2557	21 CFR 820.30(c)	21	Design input - documentation	Design input requirements were not [adequately] documented. Specifically, ***
	3671	21 CFR 820.25(a)	21	Personnel	Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
	632	21 CFR 803.17(a)(2)	20	Lack of System for Determining MDR Events	The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting. Specifically, ***
454	21 CFR 820.40(a)	19	Document review, approval by designated individual	Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance. Specifically, ***
2968	21 CFR 812.100	19	Investigator non-compliance with agreement/plan/regulations	An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, ***
3102	21 CFR 820.30(h)	19	Design transfer - Lack of or inadequate procedures	Procedures for design transfer have not been [adequately] established. Specifcally, ***
3119	21 CFR 820.75(b)	19	Lack/Inad procedure-Monitoring/Control of Validated Proces	Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifcally, ***
14718	21 CFR 820.30(g)	19	Design validation - Risk analysis	Results of the design risk analysis were not [adequately] documented. Specifically, ***
3117	21 CFR 820.70(i)	18	Software validation for automated processes	Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol. Specifically, ***
4070	21 CFR 820.30(g)	18	Design validation - documentation	The results of design validation, including [identification of the design] [method(s)] [the date] [the individual(s) performing validation], were not [adequately] documented in the design history file. Specifically, ***
2650	21 CFR 820.30(f)	17	Design verification - Lack of or inadequate procedures	Procedures for design verification have not been [adequately] established. Specifically,***
3201	21 CFR 820.40(a)	17	Not approved or obsolete document retrieval	Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
3686	21 CFR 820.90(b)(2)	17	Product rework documentation, DHR {see also 820.184}	Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, ***
14505	21 CFR 812.140(a)(3)	17	Investigator's subject records inadequate	Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current]. Specifically, ***
3108	21 CFR 820.70(e)	16	Contamination control, Lack of or inadequate procedures	Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been [adequately] established. Specifically, ***
3132	21 CFR 820.120	16	Lack of or inadequate procedures for labeling	Procedures to control labeling activities have not been [adequately] established. Specifcally, ***
3173	21 CFR 820.198(d)	16	Evaluation, timeliness, identification	Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***
3263	21 CFR 820.250(b)	16	Sampling plans	Sampling plans are not [written][based on valid statistical rationale]. Specifically, ***
3427	21 CFR 820.50(a)(2)	15	Supplier oversight	The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
3677	21 CFR 820.30(g)	15	Design validation - software validation not performed	Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
4057	21 CFR 820.20(a)	15	Management ensuring quality policy is understood	Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. Specifcally, ***
2293	21 CFR 820.20(d)	14	Quality plan	A quality plan has not been [adequately] established. Specifcally, ***
2970	21 CFR 812.100	14	Investigator lack of informed consent	Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifcally, ***
3191	21 CFR 820.30(g)	14	Design validation - production units	The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, ***
3235	21 CFR 820.72(a)	14	Equipment control activity documentation	Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, ***
3433	21 CFR 820.75(c)	14	Process changes - review, evaluation and revalidation	A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifcally, ***
4212	21 CFR 806.20(b)(4)	14	Justification for not reporting	A justification for not reporting the correction or removal action to FDA that included [conclusions] [follow-ups] [reviews] by a designated person was not included in the record.
2630	21 CFR 820.30(e)	13	Design review - documentation	The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file. Specifically, ***
3190	21 CFR 820.30(g)	13	Design validation acceptance criteria	Acceptance criteria were not established prior to the performance of validation activities. Specifically, ***
3231	21 CFR 820.70(i)	13	Documentation of software validation	Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented. Specifically, ***
3262	21 CFR 820.250(a)	13	Statistical techniques - Lack of or inadequate procedures	Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been [adequately] established. Specifically,***
3269	21 CFR 820.80(b)	13	Incoming acceptance records, documentation	Acceptance or rejection of incoming product was not documented. Specifically, ***
3313	21 CFR 820.120(d)	13	Records, DHR {see also 820.184(e)}	Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR. Specifically, ***
812	21 CFR 803.56	12	Submission Within One Month	A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted. Specifically, ***
2981	21 CFR 812.140(a)(2)(i)	12	Investigator device accountability inadequate	Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt] [batch number or code mark] of the device are not all [accurate] [complete] [current]. Specifically, ***
3149	21 CFR 820.180	12	Availability	Required records [are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA] [were not made readily available for review and copying by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed up when stored in automated data processing systems]. Specifically, ***
3171	21 CFR 820.198(b)	12	Rationale documented for no investigation	Records for complaints where no investigation was made do not include required information.
3199	21 CFR 820.40(a)	12	Document review, approval documentation	The documentation of approval of documents does not include [the document approval date] [the signature of the approving official]. Specifically, ***
3264	21 CFR 820.250(b)	12	Sampling methods - Lack of or inadequate procedures	Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established. Specifically,***
3426	21 CFR 820.50(a)(1)	12	Documented evaluation	The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
14711	21 CFR 820.160(a)	12	Lack of or inadequate procedures for distribution	Procedures for control and distribution of finished devices have not been [adequately] established. Specifically,***
14715	21 CFR 820.30(d)	12	Design output - Lack of or inadequate procedures	Procedures for design output have not been [adequately] established. Specifically,***
2928	21 CFR 812.40	11	Sponsors' general responsibilities	For an investigational study, [qualified investigators were not selected] [investigators were not provided with the information they need to conduct an investigation properly] [proper monitoring was not ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a significant risk study] [reviewing IRBs were not promptly informed of significant new information about an investigation] [FDA was not promptly informed of significant new information about an investigation]. Specifically, ***
3206	21 CFR 820.50(b)	11	Approval, inadequate purchasing data	Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been [approved] [established] [adequately approved] [adequately established]. Specifically, ***
3175	21 CFR 820.186	10	QSR	The quality system record has not been [adequately] maintained Specifically ***
3372	21 CFR 820.198(d)	10	Records of MDR Investigation	Investigation records of MDR reportable complaints do not include required information. Specifically ***
3425	21 CFR 820.50(a)(1)	10	Evaluation and Selection, Suppliers, Contractors, etc.	Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, ***
3432	21 CFR 820.75(b)(2)	10	Documentation of validated process performance	There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date performed] [the individual performing the process] [the major equipment used] for a validated process. Specifically, ***
3668	21 CFR 820.20(c)	10	Management review dates	The results and/or dates of management reviews are not documented. Specifically, ***
14714	21 CFR 820.30(c)	10	Design input - Lack of or inadequate procedures	Procedures for design input have not been [adequately] established. Specifically,***
2269	21 CFR 820.20(a)	9	Quality policy and objectives	The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically, ***
3676	21 CFR 820.30(f)	9	Design verification - documentation	The design verification results, including [identification of the design] [method(s)] [the date] [the individual(s) performing the verification], were not [adequately] documented in the design history file. Specifically, ***
502	21 CFR 820.60	8	Identification procedures, Lack of or inadequate procedures	Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established. Specifically, ***
3139	21 CFR 820.140	8	Lack of or inadequate procedures for handling	Procedures for product handling have not been [adequately] established. Specifically,***
3434	21 CFR 820.75(c)	8	Documentation - review in response to changes or deviations	There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations. Specifically, ***
14721	21 CFR 820.70(g)(2)	8	Periodic equipment inspections	Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented]. Specifically, ***
633	21 CFR 803.17(a)(3)	7	Lack of System for Timely Submission of Reports	The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers]. Specifically, ***
635	21 CFR 803.17(b)(1)	7	Info evaluated to determine if event was reportable	The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable. Specifically, ***
2980	21 CFR 812.140(a)(1)	7	Investigator correspondence records inadequate	Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not all [accurate] [complete] [current]. Specifically, ***
3193	21 CFR 820.30(g)	7	Design validation - simulated testing	The design was not validated under actual or simulated use conditions. Specifically, ***
3203	21 CFR 820.40(b)	7	Document change records, maintained.	Records of changes to documents were not [adequately] maintained. Specifically, ***
3204	21 CFR 820.40(b)	7	Change records, content	Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective]. Specifically, ***
3266	21 CFR 820.86	7	Acceptance status	The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained]. Specifically, ***
3270	21 CFR 820.80(c)	7	Documentation	In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3674	21 CFR 820.30(d)	7	Design output - documentation	Design output was not [adequately] documented before release. Specifically, ***
3699	21 CFR 820.160(b)	7	Distribution records	Distribution records [were not maintained] [do not include or refer to the location of required information]. Specifically, ***
6802	21 CFR 807.21(a)	7	Annual registration	Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA]. Specifically, ***
14717	21 CFR 820.30(g)	7	Design validation - software validation documentation	Results of the validation of the device software were not [adequately] documented. Specifically, ***
2431	21 CFR 820.30(b)	6	Design plans- updated	Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, ***
3409	21 CFR 820.200(d)	6	Service reports	Service reports [are not documented] [do not include the required information]. Specifically, ***
3683	21 CFR 820.70(g)	6	Equipment Installation, Placement, Specified Requirements	The [appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured] [equipment used in the manufacturing process does not meet specified requirements]. Specifically, ***
4193	21 CFR 806.10(b)	6	Time to report - 10 days	A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal. Specifically, ***
2984	21 CFR 812.140(a)(3)(i)	5	Investigator records of informed consent inadequate	Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current]. Specifically, ***
2991	21 CFR 812.140(b)(1)	5	Sponsor correspondence records inadequate	Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current]. Specifically, ***
3198	21 CFR 820.40(b)	5	Document changes, review and approval, communication	Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval] [communicated to appropriate personnel in a timely manner]. Specifically, ***
3232	21 CFR 820.72(a)	5	Equipment suitability & capability	Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically, ***
3236	21 CFR 820.72(b)	5	Calibration procedures - content	Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, ***
3328	21 CFR 820.180(b)	5	Retention period	Required records are not retained for [the design and expected life of the device] [at least 2 years from the date of release of the device for commercial distribution]. Specifically, ***
14507	21 CFR 812.140(a)(3)(ii)	5	Investigator adverse effect records inadequate	Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current]. Specifically, ***
14523	21 CFR 812.43(c)	5	No investigator agreement	A signed investigator agreement was not obtained from each participating investigator . Specifically,***
2339	21 CFR 820.22	4	Quality Audit/Reaudit - documentation	The dates of quality [audits][reaudits] have not been documented. Specifically, ***
2985	21 CFR 812.140(a)(3)(ii)	4	Investigator records of relevant observations inadequate	Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the investigation] [all diagnostic test results] are not all [accurate] [complete] [current]. Specifically, ***
3111	21 CFR 820.70(f)	4	Buildings	Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product]. Specifically, ***
3155	21 CFR 820.181(a)	4	DMR device specifications	The device master record does not include or refer to the location of device software specifications. Specifically, ***
3312	21 CFR 820.120(d)	4	Mixups	Labeling and packaging operations were not controlled to prevent labeling mix-ups. Specifically, ***
3343	21 CFR 820.198(e)	4	Maintained	Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3682	21 CFR 820.70(d)	4	Implementing Personnel Procedures, Health, Cleanliness.	Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, ***
4208	21 CFR 806.20(a)	4	Records not kept	There is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,***
6800	21 CFR 807.20	4	Establishment not registered	An establishment for which registration is required has not been registered. Specifically, ***
7012	21 CFR 812.100	4	Investigator lack of control of investigational devices	Devices under investigation were not properly controlled. Specifically, ***
14719	21 CFR 820.30(h)	4	Incorrect translation to production specifications	The device design was not correctly translated into production specifications. Specifically, ***
733	21 CFR 803.50(b)(1)	3	Reporting Information Reasonably Known	An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, ***
2940	21 CFR 812.43(c)(4)(i)	3	No investigation agreement statement of commitment	A signed agreement that includes a statement of the investigator's commitment to conduct an investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations] [conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was not obtained from each participating investigator. Specifically, ***
3021	21 CFR 812.150(a)(1)	3	Investigator report of unanticipated adverse effects	A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB]. Specifically, ***
3049	21 CFR 812.150(b)(5)	3	Sponsor progress reports for significant risk study	Progress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs]. Specifically, ***
3200	21 CFR 820.40(a)	3	Document locations, Dissemination, etc.	Documents were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, ***
3237	21 CFR 820.72(b)	3	Remedial action	When test/measurement equipment was found to not meet accuracy and precision limits, [no] [inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any adverse effect on the device's quality]. Specifically, ***
3309	21 CFR 820.120(b)	3	Examination for accuracy	Labeling was not sufficiently examined by a designated individual for accuracy including [the correct expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional processing instructions] before release. Specifically, ***
3310	21 CFR 820.120(b)	3	DHR documentation of label release {see also 820.184}	The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner. Specifically, ***
4437	21 CFR 803.40(b)	3	Report of malfunction likely to cause death or injury	The importer failed to submit a report to the manufacturer on FDA Form 3500A within 30 days concerning information that one of the devices marketed by the importer has malfunctioned and that such device or a similar device marketed by the importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
6803	21 CFR 807.20(a)	3	Devices not listed	Devices for which listing is required have not been listed. Specifically, ***
14508	21 CFR 812.140(a)(4)	3	Investigator record of protocol deviations inadequate	Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,***
636	21 CFR 803.17(b)(2)	2	Reports and information documentation	The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, ***
640	21 CFR 803.18(a)	2	Event files--failure to establish	MDR event files have not been established and maintained. Specifically, ***
658	21 CFR 803.30(a)(2)	2	Report of Serious Injury Within 10 Days	The user facility did not submit FDA Form 3500A or electronic equivalent to the [known device manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility. Specifically, ***
2602	21 CFR 820.30(d)	2	Design output - review and approval	Design output was not [reviewed] [approved] before release. Specifically, ***
2949	21 CFR 812.46(a)	2	Sponsor securing investigator compliance	An investigator was not complying with the [signed agreement] [investigational plan] [requirements of the regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator was not promptly secured] [shipments of the investigational device to the investigator were not discontinued] [the investigator's participation in the investigation was not terminated]. Specifically, ***
2973	21 CFR 812.110(a)	2	Subject participation prior to study approval	Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
2992	21 CFR 812.140(b)(2)	2	Sponsor device shipment records inadequate	Records of shipment of an investigational device that include the [name and address of the consignee] [type and quantity of device] [date of shipment] [batch number or code mark] reports are not all [accurate] [complete] [current]. Specifically, ***
2993	21 CFR 812.140(b)(2)	2	Sponsor device disposition records inadequate	Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current]. Specifically, ***
3046	21 CFR 812.150(b)(4)	2	No 6-month sponsor reports of current investigators	Current lists of the names and addresses of all investigators participating in an investigation were not [always] submitted to FDA at six month intervals after FDA approval of the investigation. Specifically, ***
3063	21 CFR 812.140(a)(3)(iii)	2	Investigator records of exposure to device inadequate	Records of each subject's exposure to the device, including [the date and time of each use] [the use of any other therapy] are not all [accurate] [complete] [current]. Specifically, ***
3109	21 CFR 820.70(d)	2	Personnel requirements, Lack of or inadequate requirements	Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing]. Specifically, ***
3138	21 CFR 820.130	2	Packaging	Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution. Specifically, ***
3224	21 CFR 820.70(g)(2)	2	Periodic equipment inspection lack of or inadequate procedu	Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established. Specifically, ***
3230	21 CFR 820.70(i)	2	Validation of changes to automated process software	Changes to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance. Specifically, ***
3239	21 CFR 820.72(b)	2	Remedial action - documentation	Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3323	21 CFR 820.170(b)	2	Installer records	The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.
3346	21 CFR 820.200(b)	2	Analyzing service report	Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3347	21 CFR 820.200(c)	2	Service reports/MDRs/complaints	Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
3672	21 CFR 820.30(c)	2	Design input - review and approval	Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
4192	21 CFR 806.10(a)(2)	2	Report of violation of the Act (see 803.52(e)(9))	A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA. Specifically, ***
4211	21 CFR 806.20(b)(3)	2	Events	A description of the events that led to the correction or removal actions was not contained in the record. Specifically,***
4252	21 CFR 821.25(c)(3)	2	Quality assurance procedures: 6-month & annual audits	A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling [has not been established] [is not complete] [has not been followed]. Specifically,***
4430	21 CFR 803.18(d)(1)	2	Distributor responsibilities for records	Device complaint records are not [established] [maintained] by the device distributor, including any relevant [incident information] [information regarding the evaluation of the allegations]. Specifically, ***
4431	21 CFR 803.18(d)(1)	2	Distributor's device incident records	Device incident records kept by device distributors are not [prominently identified as such] [filed by device] [maintained in written form] [maintained in electronic form which is backed up]. Specifically, ***
4436	21 CFR 803.40(a)	2	Report of death, injury by marketed device	The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving information that one of its marketed devices may have caused or contributed to a [death] [serious injury]. Specifically, ***
9673	21 CFR 809.10(c)(2)(i)	2	Not exempt--lacks Research Use Only statement	A [shipment] [delivery] of an in vitro diagnostic product for an investigation which is not subject to part 812 is not exempt from the requirements for labels and accompanying labeling because all labeling does not bear the prominently placed statement "For Research Use Only. Not for use in diagnostic procedures". Specifically, ***
14516	21 CFR 812.25(e)	2	Sponsor's lack of written monitoring procedures	There are no written procedures for monitoring an investigational device study. Specifically,***
512	21 CFR 820.65	1	Traceability Lack of or inadequate {see also 820.120(e)}	Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been [adequately] established. Specifically, ***
621	21 CFR 803.11	1	Failure to use FDA Form 3500A	An MDR adverse event report was submitted on a form other than FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent. Specifically, ***
641	21 CFR 803.18(a)	1	Identification and filing of MDR Files	MDR event files have not been [prominently identified as such] [filed to facilitate timely access]. Specifically, ***
644	21 CFR 803.18(b)(1)(ii)	1	Files do not contain copies of MDR forms	MDR event files do not contain copies of all MDR forms and other information related to the event that was submitted to [FDA] [the manufacturer] [the importer] [the distributor] [other entities]. Specifically, ***
648	21 CFR 803.18(e)	1	MDR not evaluated per 820.162 and 820.198	A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding [Failure Investigations] [Complaint Files]. Specifically, ***
654	21 CFR 803.20(a)(2)	1	Sections G and H not completed by mfr.	The device manufacturer did not complete Sections G and H on the back side of FDA Form 3500A. Specifically, ***
735	21 CFR 803.50(b)(2)	1	Explanation of Incomplete Information	An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information. Specifically, ***
738	21 CFR 803.52(a)(1)	1	Patient Name or Other Identifier	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient name or other identifier. Specifically, ***
743	21 CFR 803.52(b)(1)	1	Adverse Event of Product Problem	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the adverse event or product problem. Specifically, ***
771	21 CFR 803.52(e)(1)	1	Contact Office Name and Address	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the [contact office name and address] [device manufacturing site]. Specifically, ***
773	21 CFR 803.52(e)(3)	1	Report Sources	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the report sources. Specifically, ***
778	21 CFR 803.52(f)(1)	1	Type of Reportable Event	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the type of reportable event. Specifically, ***
783	21 CFR 803.52(f)(6)	1	Evaluation Codes	An individual medical device manufacturer report submitted per FDA Form 3500A did not include in Block H the evaluation codes (including event codes, method of evaluation, result and conclusion codes). Specifically, ***
784	21 CFR 803.52(f)(7)	1	Remedial Action Taken	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was taken and type. Specifically, ***
2338	21 CFR 820.22	1	Quality audit - audit report review	Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically, ***
2930	21 CFR 812.42	1	Sponsor began study before IRB/FDA approval	[An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***
2933	21 CFR 812.43(a)	1	Investigator(s) not qualified	One or more investigators were selected who were not qualified by [training] [experience] to investigate a device. Specifically, ***
2935	21 CFR 812.43(b)	1	Sponsor shipped devices to unqualified person(s)	Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation. Specifically, ***
2937	21 CFR 812.43(c)(1)	1	No curriculum vitae in investigator agreement	The signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae. Specifically, ***
2952	21 CFR 812.46(b)(1)	1	No evaluation of unanticipated adverse effects	An evaluation of reported unanticipated adverse device effects was not conducted. Specifically,***
2966	21 CFR 812.66	1	No IRB notification of significant risk determination	The reviewing IRB did not notify [the investigator] [the sponsor] after determining that a device study, presented for approval as a non-significant risk device study, was actually a significant risk device study. Specifically, ***
2982	21 CFR 812.140(a)(2)(ii)	1	Investigator records of persons receiving devices inadequate	Records of persons who [received] [used] [disposed] of each device are not all [accurate] [complete] [current]. Specifically, ***
2994	21 CFR 812.140(b)(3)	1	Sponsor records of investigator agreements inadequate	Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
3007	21 CFR 812.140(d)	1	Record retention inadequate	Required records were not all maintained [during the investigation] [for a period of two years after the date on which an investigation was terminated or completed] [for a period of two years after the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol]. Specifically, ***
3027	21 CFR 812.150(a)(4)	1	Investigator non-emergency safety or soundness changes	In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] . Specifically, ***
3028	21 CFR 812.150(a)(4)	1	No approval for investigator change in non-emergency	Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation. Specifically, ***
3029	21 CFR 812.150(a)(4)	1	Investigator report of emergency use	The [sponsor] [reviewing IRB] was not notified [within five working days] of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency situation. Specifically, ***
3035	21 CFR 812.150(a)(7)	1	Investigator report in response to a request	Information about a device investigation that was [accurate] [complete] [current] was not provided upon request by [a reviewing IRB] [FDA]. Specifically, ***
3064	21 CFR 812.140(a)(4)	1	Investigator protocol records inadequate	Copies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***
3113	21 CFR 820.70(g)	1	Equipment design and installation	Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
3115	21 CFR 820.70(h)	1	Use and removal, Lack of or inadequate procedures	Procedures for the use and removal of manufacturing material have not been [adequately] established. Specifically, ***
3225	21 CFR 820.70(g)(3)	1	Adjustment	Inherent limitations or allowable tolerances [are not posted on or near] [are not readily available to personnel performing adjustments of] equipment requiring periodic adjustments. Specifically, ***
3332	21 CFR 820.184(e)	1	ID label, labeling	'The device history record does not include the primary identification label and labeling for each device. Specifically, ***
3380	21 CFR 820.198(e)(6)	1	Results of investigation	Records of complaint investigations do not include the [dates] [results] of the investigation. Specifically, ***
3383	21 CFR 820.198(g)	1	Foreign complaint files	'The manufacturer's formally designated complaint unit is located outside of the United States and complaint records are not reasonably accessible in the United States. Specifically, ***
3841	21 CFR 820.90(b)(2)	1	Product rework adverse effects {see also 820.184}	Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from rework upon the product. Specifically, ***
4200	21 CFR 806.10(c)(7)	1	Event description	The events that led to reporting and/or conducting the correction or removal actions were not described. Specifically,***
4203	21 CFR 806.10(c)(10)	1	Date of manufacture, dist., expiration	The report to FDA of the correction or removal of a device did not include the [date of manufacture] [date of distribution] [expiration date] [life expectancy]. Specifically,***
4204	21 CFR 806.10(c)(11)	1	Domestic & foreign consignees	The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject to correction or removal actions and number of devices distributed to each consignee were not reported. Specifically,***
4213	21 CFR 806.20(b)(5)	1	Records of communications	A copy of all communications regarding the correction or removal action was not contained in the record. Specifically,***
4228	21 CFR 821.25(a)	1	Written tracking program	An adequate written device tracking program was not [adopted] [established] [complete] [implemented] for each device subject to a tracking order. Specifically, ***
4248	21 CFR 821.25(b)	1	Records not current	Current records for each tracked device while in distribution for use were not [maintained] [complete] [up-to-date] [in accordance with written SOPs]. Specifically,***
6804	21 CFR 807.21(b)	1	Listing not updated	Existing device information changed, but the listing was not updated during [June] [December] (or earlier) as required. Specifically, ***
6805	21 CFR 807.25(b)	1	Device activities not reported	Device activities have not been reported to FDA. Specifically, ***
6808	21 CFR 807.26	1	Changes	FDA was not notified within 30 days of changes in [individual ownership] [corporate structure] [partnership structure] [location] of your registered establishment. Specifically, ***
6847	21 CFR 807.30(b)	1	Listing not updated or update not timely	Device listing information was not updated [in a timely manner]. Specifically, ***
9111	21 CFR 809.10(a)(4)	1	Hazard warnings/limiting statements	An in vitro diagnostic [product label] [outside container] [wrapper] does not bear [warnings appropriate to the hazard presented by the product] [appropriate limiting statements to the intended use of the product] as required. Specifically, ***
9176	21 CFR 809.20(b)	1	Compliance with GMP	In vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System Regulation. Specifically, ***
9670	21 CFR 809.10(a)(4)	1	"For IVD Use" statement	The [product label] [outside container] [wrapper] of an in vitro diagnostic product does not bear the statement "For In Vitro Diagnostic Use". Specifically, ***
14510	21 CFR 812.150(b)(6)	1	Sponsor notif. of rqst. to return/repair/dispose not timely	Notification to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device [was not made within 30 working days after the request] [did not state why the request was made]. Specifically, ***
14517	21 CFR 812.35(a)(1)	1	No approval for changes requiring prior approval	[FDA] [IRB] approval was not obtained for changes to an investigational plan that require prior approval. Specifically, ***
17003	FDCA 501(a)	1	Medical Device Field Exam	During a field examination of medical device products at your facility the following [was] [were] observed:

Drugs

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Drugs	1105	21 CFR 211.22(d)	201	Procedures not in writing, fully followed	The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***
	1361	21 CFR 211.100(a)	128	Absence of Written Procedures	There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***
	3603	21 CFR 211.160(b)	124	Scientifically sound laboratory controls	Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***
	2027	21 CFR 211.192	123	Investigations of discrepancies, failures	There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***
	1112	21 CFR 211.25(a)	92	Training--operations, GMPs, written procedures	Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, ***
	1358	21 CFR 211.100(b)	90	SOPs not followed / documented	Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***
	1215	21 CFR 211.67(b)	89	Written procedures not established/followed	Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, ***
	1213	21 CFR 211.67(a)	86	Cleaning / Sanitizing / Maintenance	Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, ***
	1883	21 CFR 211.165(a)	76	Testing and release for distribution	Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. Specifically, ***
	3585	21 CFR 211.110(a)	70	Control procedures to monitor and validate performance	Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, ***
	2009	21 CFR 211.188	61	Prepared for each batch, include complete information	Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. Specifically, ***
	2026	21 CFR 211.192	60	Quality control unit review of records	Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Specifically, ***
	1274	21 CFR 211.68(a)	59	Calibration/Inspection/Checking not done	Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***
	1177	21 CFR 211.63	56	Equipment Design, Size and Location	Equipment used in the manufacture, processing, packing or holding ofdrug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, ***
	1914	21 CFR 211.166(a)	55	Lack of written stability program	There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***
	2419	21 CFR 211.198(a)	54	Complaint Handling Procedure	Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, ***
	4314	21 CFR 211.84(d)(2)	50	Reports of Analysis (Components)	Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***
	1133	21 CFR 211.25(a)	49	GMP Training Frequency	GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***
	4391	21 CFR 211.180(e)(2)	47	Items to cover on annual reviews	Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, ***
	9001	21 CFR 211.22(a)	46	Lack of quality control unit	There is no quality control unit. Specifically, ***
	1540	21 CFR 211.125(a)	45	Strict control not exercised over labeling issued	Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, ***
	2028	21 CFR 211.192	43	Extent of discrepancy, failure investigations	Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy]. Specifically, ***
	4352	21 CFR 211.160(b)(4)	41	Calibration - at intervals, written program, remedial action	The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]. Specifically, ***
	1787	21 CFR 211.80(a)	40	Procedures To Be in Writing	Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
	1111	21 CFR 211.25(a)	38	Training , Education , Experience overall	Employeesengaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***
	1890	21 CFR 211.165(e)	38	Test methods	The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***
	4576	21 CFR 211.192	38	No written record of investigation	Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, ***
	4389	21 CFR 211.198(a)	37	Procedures to be written and followed	Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***
	1809	21 CFR 211.160(a)	36	Following/documenting laboratory controls	Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
	4303	21 CFR 211.67 b)	35	Written procedures fail to include	Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation]. Specifically, ***
	4402	21 CFR 211.192	35	Written record of investigation incomplete	Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up. Specifically, ***
	1194	21 CFR 211.42(c)	34	Defined areas of adequate size for operations	The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
	1451	21 CFR 211.113(b)	33	Procedures for sterile drug products	Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***
	1943	21 CFR 211.180(e)(1)	33	Review of representative number of batches	Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, ***
	4340	21 CFR 211.142	33	Written warehousing procedures established/followed	Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***
	1450	21 CFR 211.113(a)	31	Procedures for non-sterile drug products	Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***
	2031	21 CFR 211.194(a)	30	Complete test data included in records	Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***
	1767	21 CFR 211.137(a)	29	Expiration date lacking	Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***
	1810	21 CFR 211.160(a)	29	Lab controls established, including changes	The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
	3565	21 CFR 211.58	29	Buildings not maintained in good state of repair	Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***
	3570	21 CFR 211.100(a)	27	Approval and review of procedures	Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit]. Specifically, ***
	4413	21 CFR 211.194(a)(8)	27	Second person sign off	Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards]. Specifically, ***
	1912	21 CFR 211.166(a)	26	Written program not followed	The written stability testing program is not followed. Specifically, ***
	3572	21 CFR 211.100(b)	26	Procedure Deviations Recorded and Justified	Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***
	4306	21 CFR 211.80(a)	26	Written Procedures Not Followed	Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
	3571	21 CFR 211.100(a)	25	Changes to Procedures Not Reviewed, Approved	Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
	1227	21 CFR 211.67(c)	24	Cleaning/maintenance records not kept	Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***
	1395	21 CFR 211.103	24	Actual vs. theoretical yields not determined	Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product. Specifically, ***
	1833	21 CFR 211.84(d)(1)	24	Identity Testing of Each Component	The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. Specifically, ***
	1975	21 CFR 211.182	24	Written records kept in individual logs	Written records of major equipment [cleaning] [maintenance] [use]are not included in individual equipment logs. Specifically, ***
	3602	21 CFR 211.160(a)	24	Deviations from laboratory control requirements	Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, ***
	3559	21 CFR 211.56(a)	22	Sanitation--buildings not clean, free of infestation	Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***
	1891	21 CFR 211.165(f)	21	Failing drug products not rejected	Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***
	1885	21 CFR 211.165(b)	20	Microbiological testing	Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***
	4342	21 CFR 211.142(b)	20	Storage under appropriate conditions	Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***
	4336	21 CFR 211.150	19	Written distribution procedure	Written distribution procedures are not [established] [followed]. Specifically, ***
	4372	21 CFR 211.188(b)(8)	18	Labeling control records including specimens or copies	Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. Specifically, ***
	8907	21 CFR 314.81(b)(1)(ii)	18	Contamination, chemical or physical change, deterioration	An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, ***
	1098	21 CFR 211.22(c)	17	Approve or reject procedures or specs	The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***
	1263	21 CFR 211.68(b)	17	Computer control of master formula records	Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, ***
	1448	21 CFR 211.111	17	Establishment of time limitations	Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***
	1452	21 CFR 211.113(b)	17	Validation lacking for sterile drug products	Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process. Specifically, ***
	1550	21 CFR 211.125(f)	17	Procedures Written and Followed	Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
	1926	21 CFR 211.166(b)	17	Adequate number of batches on stability	An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date. Specifically, ***
2007	21 CFR 211.186(a)	17	Signature and checking of records -- 2 persons	The master production and control records for each batch size of drug product are not[prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person]. Specifically, ***
3583	21 CFR 211.110(a)	17	Written in-process control procedures	Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch. Specifically, ***
3632	21 CFR 211.170(b)	17	Annual visual exams of drug products	Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. Specifically, ***
1626	21 CFR 211.130	16	Procedures are written, and followed	Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, ***
1920	21 CFR 211.166a)(3)	16	Valid stability test methods	The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***
2008	21 CFR 211.186(a)	16	Written procedures followed	Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, ***
1261	21 CFR 211.68(a)	15	Written calibration / inspection records not kept	Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. Specifically, ***
1270	21 CFR 211.68(b)	15	input/output verification	Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***
2619	21 CFR 211.198(b)(2)	15	Complaint Investigation/Follow-Up Findings	Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, ***
3616	21 CFR 211.165(d)	15	Acceptance criteria for sampling & testing	Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release. Specifically, ***
8911	21 CFR 314.81(b)(1)(ii)	15	Failure to meet specifications	An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application. Specifically, ***
1134	21 CFR 211.25(b)	14	Supervisor Training/Education/Experience	Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. Specifically, ***
1801	21 CFR 211.84(a)	14	Components withheld from use pending release	Each lot of [components] [drug product containers] [closures] is not withheldfrom use until the lot has been sampled, tested, examined, and released by the quality control unit. Specifically, ***
1942	21 CFR 211.180(e)	14	Records reviewed annually	Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. Specifically, ***
4357	21 CFR 211.166(a)	14	Results not used for expiration dates, storage cond.	Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***
4401	21 CFR 211.186(b)(9)	14	Complete instructions, procedures, specifications et. al.	Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***
1033	21 CFR 211.22(a)	13	Authority lacking to review records, investigate errors	The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***
3592	21 CFR 211.110(c)	12	In-process materials characteristics testing	In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, ***
3613	21 CFR 211.160(b)(4)	12	Establishment of calibration procedures	Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, ***
4315	21 CFR 211.84(d)(2)	12	Testing Each Component for Conformity with Specs	Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***
4353	21 CFR 211.160(b)(4)	12	Instruments, apparatus, et. al. not meeting specs	The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, ***
1495	21 CFR 211.122(a)	11	Written procedures describing in detail	There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, ***
1790	21 CFR 211.80(b)	11	Handling and Storage to Prevent Contamination	There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination. Specifically, ***
1844	21 CFR 211.84(d)(2)	11	Establish reliability of supplier's C of A	Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. Specifically, ***
2003	21 CFR 211.184(c)	11	Individual inventory record	Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associatedbatch or lot of drug product. Specifically, ***
3547	21 CFR 211.46(b)	11	Equipment for Environmental Control	Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, ***
4307	21 CFR 211.80(d)	11	Status of Each Lot Identified	Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected. Specifically, ***
6732	21 CFR 314.80(c)(1)(i)	11	Late submission of 15-day report	Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. Specifically, ***
1049	21 CFR 211.22(a)	10	Approve or reject components, products	The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products]. Specifically, ***
1136	21 CFR 211.25(c)	10	Inadequate number of personnel	The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
1162	21 CFR 211.28(a)	10	Protective Apparel Not Worn	Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***
1411	21 CFR 211.105(b)	10	Distinctive ID or code not recorded in batch record	The batch records do not record the distinctive [identification number] [code] [name of equipment] to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. Specifically, ***
1434	21 CFR 211.42(c)(10)(iv)	10	Environmental Monitoring System	Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***
1505	21 CFR 211.122(d)	10	Label storage access limited to authorized personnel	Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***
1722	21 CFR 211.134(a)	10	Correct labels during finishing operations	Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, ***
2567	21 CFR 211.198(a)	10	Adverse Drug Experience	Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent [serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***
4338	21 CFR 211.150(b)	10	Recall facilitation	A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established. Specifically, ***
4355	21 CFR 211.165(c)	10	Sampling and testing plans not followed	Written procedures for sampling and testing plans are not followed for each drug product. Specifically, ***
4400	21 CFR 211.186(b)(8)	10	Description of containers, labels, et. al.	Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling]. Specifically, ***
1169	21 CFR 211.42(a)	9	Buildings of Suitable Size, Construction, Location	Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations. Specifically, ***
1774	21 CFR 211.142(a)	9	Quarantine - actual practice	Drug products are not quarantined before being released by the quality control unit. Specifically, ***
2033	21 CFR 211.194(c)	9	Testing and standardization of standards et. al.	Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions]. Specifically, ***
3629	21 CFR 211.170(b)	9	Reserve samples identified, representative, stored	Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling]. Specifically, ***
4320	21 CFR 211.84(d)(6)	9	Microbiological Contamination Exam	Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use. Specifically, ***
6730	21 CFR 314.80(b)	9	Failure to develop written procedures	Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, ***
1086	21 CFR 211.22(b)	8	Adequate lab facilities not available	Adequate lab facilities for testing and approval or rejection of [components] [drug product containers] [closures] [packaging materials] [in-process materials] [drug products] are not available to the quality control unit. Specifically, ***
1454	21 CFR 211.115(a)	8	Reprocessing procedures not written or followed	Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not [written] [followed]. Specifically, ***
1633	21 CFR 211.130(d)	8	Examination of packaging and labeling	Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records]. Specifically, ***
1851	21 CFR 211.84(e)	8	Rejecting When Specifications Not Met	Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity. Specifically, ***
1886	21 CFR 211.165(c)	8	Sampling and testing plans not described	Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested]. Specifically, ***
2034	21 CFR 211.194(d)	8	Laboratory equipment calibration records	Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
3561	21 CFR 211.56(b)	8	Written sanitation procedures lacking	There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, ***
3639	21 CFR 211.204	8	Returned drug procedures in writing and followed	Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, ***
4302	21 CFR 211.56(b)	8	Written sanitation procedures not followed	Written procedures for sanitation are not followed. Specifically, ***
4351	21 CFR 211.160(b)(3)	8	Drug products - samples representative, identified properly	Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, ***
4378	21 CFR 211.188(b)(2)	8	Identity of major equipment and lines used	Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced. Specifically, ***
4382	21 CFR 211.198(b)(2)	8	Written record of complaint to include findings, follow-up	Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, ***
1802	21 CFR 211.84(b)	7	Representative Samples	Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, ***
1876	21 CFR 211.180(a), (b)	7	Record maintenance 1 year (except exempt OTC)	All records of[production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date. Specifically, ***
1917	21 CFR 211.166(a)(1)	7	Sample size - test intervals	The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, ***
2205	21 CFR 211.186(b)(9)	7	Manufacturing Instructions and Specifications	The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions]. Specifically, ***
2401	21 CFR 211.194(a)(4)	7	Complete Test Data	Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***
3582	21 CFR 211.105(a)	7	Identification of containers, lines, equipment	All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch]. Specifically, ***
4341	21 CFR 211.142(a)	7	Quarantine - written procedures	Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit. Specifically, ***
4368	21 CFR 211.188(b)(12)	7	Investigations made into any unexplained discrepancy	Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed. Specifically, ***
4369	21 CFR 211.188(b)(11)	7	Identification of persons involved, each significant step	Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced. Specifically, ***
4375	21 CFR 211.188(b)(5)	7	In-process and laboratory control results	Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced. Specifically, ***
4406	21 CFR 211.194(a)(2)	7	Suitability of testing methods verified	The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
1163	21 CFR 211.28(b)	6	Habits of good sanitation & health	Production personnel were not practicing good sanitation and health habits. Specifically, ***
1632	21 CFR 211.130(c)	6	Lot or control number assigned	The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. Specifically, ***
1777	21 CFR 211.150(b)	6	Distribution Recall System	The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary. Specifically, ***
1869	21 CFR 211.94(c)	6	Containers & Closures Clean, Sterilized, Pyrogen-free	Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use. Specifically, ***
1976	21 CFR 211.182	6	Specific information required in individual logs	Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, ***
1978	21 CFR 211.182	6	Personnel dating/signing equipment log	The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, ***
2569	21 CFR 211.198(b)	6	Maintenance of Complaint File	Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints. Specifically, ***
3550	21 CFR 211.46(c)	6	Exhaust systems inadequate to control air contamination	Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production. Specifically, ***
3557	21 CFR 211.52	6	Washing and toilet facilities are deficient	Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness]. Specifically, ***
3591	21 CFR 211.110(b)	6	In-process materials specifications	In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures where appropriate]. Specifically, ***
3623	21 CFR 211.170(a)	6	Active ingredient retained sample kept	A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained]. Specifically, ***
4325	21 CFR 211.110(a)	6	Control procedures fail to include the following	Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions]. Specifically,***
4328	21 CFR 211.122(a)	6	Written procedures not followed	Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, ***
4374	21 CFR 211.188(b)(6)	6	Inspection of packaging and labeling area	Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced. Specifically, ***
4412	21 CFR 211.194(a)(7)	6	Signatures and dates--person who performs test	Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed]. Specifically, ***
1079	21 CFR 211.22(a)	5	Contract drug products--lack of responsibility	The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company. Specifically, ***
1435	21 CFR 211.42(c)(10)(v)	5	Cleaning System	Aseptic processing areas are deficient regarding the system for cleaningand disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***
1630	21 CFR 211.130(b)	5	Unlabeled filled containers controls	Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of individual containers, lots or portions of lots. Specifically, ***
1797	21 CFR 211.82(a)	5	Examination on receipt, before acceptance	Each container or grouping of containers of [components] [drug product containers] [closures] is not examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container damage] [broken seals][contamination]. Specifically, ***
1842	21 CFR 211.84(d)(1)	5	Component identity verification	Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,***
1879	21 CFR 211.180(c)	5	Records not made readily available to FDA	Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection. Specifically, ***
2004	21 CFR 211.184(d)	5	Labeling: documentation of exam and review	There is no documentation of the examination and review of labels and labeling for conformity with [established specifications] [the assigning of a lot or control number]. Specifically, ***
2012	21 CFR 211.188(b)	5	Batch production and Batch Control Record Requirements	The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically, ***
2020	21 CFR 211.188(b)(8)	5	Labeling Control Records and Label Copies	The batch production and control records are deficient in that they do notinclude [complete labeling control records] [specimen] [copy] of labeling. Specifically, ***
2044	21 CFR 211.196	5	Distribution Record Requirements	Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, ***
2621	21 CFR 211.198(b)(3)	5	Reason for Not Conducting Complaint Investigation	Complaint records are deficient in that they do not document the reason and the individualmaking the decision not to conduct a complaint investigation. Specifically, ***
3445	21 CFR 211.65(a)	5	Equipment construction - reactive surfaces	Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Specifically, ***
4304	21 CFR 211.68(b)	5	Written record not kept of program and validation data	A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes. Specifically, ***
4324	21 CFR 211.110(b)	5	In-process materials specifications testing	Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, ***
4330	21 CFR 211.130(e)	5	Packaging line inspection documentation	Results of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, ***
4377	21 CFR 211.188(b(3)	5	Identification of eachcomponent or in-process material	Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced. Specifically, ***
4380	21 CFR 211.198(b)(3)	5	Determination not to conduct investigation of complaint	The written record did not include the [reason an investigation was found not to be necessary] [name of the responsible person making the determination not to conduct an investigation] when an investigation into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] was not conducted. Specifically, ***
4388	21 CFR 211.198(a)	5	Complaints reviewed by Quality Control Unit	Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need for an investigation of any unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications]. Specifically, ***
4418	21 CFR 211.42(b)	5	Adequate space lacking to prevent mix-ups and contamination	The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination. Specifically, ***
6728	21 CFR 314.80(b)	5	Failure to review ADE information	Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers]. Specifically, ***
1224	21 CFR 211.67(b)(6)	4	Cleaning SOP/inspection	Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, ***
1388	21 CFR 211.101(d)	4	Component addition checked by 2nd person	Each component is not added to a batch by one person and verified by a second person. Specifically, ***
1396	21 CFR 211.42(c)(2)	4	Rejected Material Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition. Specifically,***
1498	21 CFR 211.122(b)	4	Labeling and packaging improperly approved/released	Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, ***
1541	21 CFR 211.125(b)	4	Examination of issued labels	Labeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records. Specifically, ***
1725	21 CFR 211.134(c)	4	Examinations documented	The results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, ***
1728	21 CFR 211.87	4	Retest of approved components/containers/closures	Approved [components] [drug product containers] [closures] are not retested or reexamined as appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to conditions that might have an adverse effect]with subsequent approval or rejection by the quality control unit. Specifically, ***
1768	21 CFR 211.137(b)	4	Storage conditions	Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, ***
2420	21 CFR 211.198(a)	4	Quality Control Review	Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit. Specifically, ***
3553	21 CFR 211.48(a)	4	Plumbing System Defects	The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, ***
3569	21 CFR 211.89	4	Quarantine of Rejected Components et. al.	Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
4317	21 CFR 211.84(d)(3)	4	Certificates of Testing (Containers, Closures)	Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals]. Specifically, ***
4359	21 CFR 211.170(a)(1), (b)(1)	4	Retention time of reserve samples, in general	Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product.
4403	21 CFR 211.194(b)	4	Test method modification records do not include	Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method]. Specifically, ***
4404	21 CFR 211.194(a)(1)	4	Sample identification and other information	Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing]. Specifically, ***
4410	21 CFR 211.194(a)(5)	4	Calculations performed are in the records	Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, ***
6829	21 CFR 314.80(c)(2)	4	Failure to report non-alert ADEs	Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report. Specifically, ***
8906	21 CFR 314.81(b)(1)(i)	4	Mix-up	An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another article. Specifically, ***
1174	21 CFR 211.42(b)	3	Product flow through building is inadequate	The flowof [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination. Specifically, ***
1207	21 CFR 211.65(b)	3	Substances That Come in Contact	Substances required for equipment operations such as lubricants and coolants come in contact with [components] [drug product containers] [closures] [in-process materials] [drug product] so as to alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements. Specifically, ***
1371	21 CFR 211.101(a)	3	Batches Formulated to less than 100%	Written production and control procedures include batches formulated with the intent to provide less than100 percent of the labeled or established amount of active ingredient. Specifically, ***
1430	21 CFR 211.42(c)(10)(i)	3	Floors, walls, ceiling surfaces	Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***
1433	21 CFR 211.42(c)(10)(iii)	3	Air Supply	Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, ***
1496	21 CFR 211.122(a)	3	Sampling/testing of labeling/packaging materials	Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product. Specifically, ***
1506	21 CFR 211.122(e)	3	Destruction of obsolete labeling	Obsolete or outdated labels, labeling and packaging materials are not destroyed. Specifically, ***
1636	21 CFR 211.130(e)	3	Packaging line inspection before use	Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations. Specifically, ***
1637	21 CFR 211.130(e)	3	Packaging line inspection after use	Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed. Specifically, ***
1776	21 CFR 211.150(a)	3	Distribution of oldest approved drugs	The oldest approved stock of drug products are not distributed first and there is no justification for this practice. Specifically,***
1796	21 CFR 211.80(d)	3	Identification of Each Lot in Each Shipment	Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures]. Specifically, ***
1823	21 CFR 211.84(c)(4)	3	Top/Middle/Bottom container sampling	Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. Specifically, ***
1849	21 CFR 211.84(d)(6)	3	Objectionable microbiological contamination	Each lot of a [component] [drug product containers] [closures] liable to objectionablemicrobiological contamination is deficiently subjected to microbiological tests before use. Specifically,***
1852	21 CFR 211.94(a)	3	Reactive/Additive/Absorptive Containers/Closures	Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements. Specifically, ***
1868	21 CFR 211.94(b)	3	Protection from external factors	Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. Specifically, ***
1928	21 CFR 211.166(c)(1)	3	Homeopathic drugs, assessment of stability	There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use]. Specifically, ***
1933	21 CFR 211.167(a)	3	Sterility/pyrogens - test methods written, followed	Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ***
2032	21 CFR 211.194(b)	3	Test method modification records not maintained	Complete records are not maintained of any modification of an established method employed in testing. Specifically, ***
2035	21 CFR 211.194(e)	3	Stability testing records notincluded	Laboratory records do not include complete records of all stability testing performed. Specifically, ***
2399	21 CFR 211.194(a)(2)	3	Laboratory Test Method Verification	Verification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records]. Specifically, ***
2406	21 CFR 211.194(a)(8)	3	Identification of Person Performing Review of Lab Records	Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy. Specifically, ***
4343	21 CFR 211.160(b)(1)	3	Incoming lots - conformance to written specs-	Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of drug products. Specifically, ***
4344	21 CFR 211.160(b)(1)	3	Sampling and testing procedures described	Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, ***
4347	21 CFR 211.160(b)(2)	3	In process materials - conformance to written specs	Laboratory controls do not include a determination of conformance to writtenspecificationsfor in-process materials. Specifically, ***
4349	21 CFR 211.160(b)(2)	3	In-process samples representative, identified properly	Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, ***
4373	21 CFR 211.188(b)(7)	3	Actual yield, % of theoretical yield	The batch production and control records do not include a statement of the [actual yield] [percentage of theoretical yield] at appropriate stages of processing for each batch of drug product produced. Specifically, ***
4376	21 CFR 211.188(b)(4)	3	Weights and measures of components used	Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced. Specifically, ***
4379	21 CFR 211.188(b)(1)	3	Dates not included for each significant step	Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, ***
4399	21 CFR 211.186(b)(7)	3	Theoretical yield statement including percentages	Master production and control records lack a statement of theoretical yield [including the maximum and minimum percentages of theoretical yield beyond which investigation is required]. Specifically, ***
4409	21 CFR 211.194(a)(4)	3	Data secured in course of each test	Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested]. Specifically, ***
4414	21 CFR 211.204	3	Record information maintained	Records of returned drug products are not maintained. Specifically, ***
6823	21 CFR 314.80(c)	3	Failure by applicant to report ADE	Adverse drug experience information has not been reported to FDA. Specifically, ***
6831	21 CFR 314.80(c)(2)	3	Late submission of quarterly safety reports	Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, ***
6832	21 CFR 314.80(c)(2)	3	Late submission of annual safety reports	Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. Specifically, ***
8912	21 CFR 314.81(b)(2)	3	Timely submission	An annual report was not submitted [each year] [within 60 days of the anniversary date of U. S. approval of the application] to the FDA division responsible for reviewing the application. Specifically, ***
1168	21 CFR 211.34	2	Consultant Records	Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, ***
1220	21 CFR 211.67(b)(3)	2	Cleaning SOPs/instructions	Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance. Specifically, ***
1223	21 CFR 211.67(b)(5)	2	Cleaning SOPs/equipment protection	Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use. Specifically, ***
1251	21 CFR 211.42(c)(1)	2	Incoming material area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. Specifically, ***
1256	21 CFR 211.68(b)	2	Backup file not maintained	Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***
1393	21 CFR 211.103	2	Yield calculations not verified by 2nd person	Yield calculations are not performed by one person and independently verified by a second person. Specifically, ***
1418	21 CFR 211.42(c)(7)	2	Quarantined Drug Products Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release. Specifically, ***
1421	21 CFR 211.42(c)(10)	2	Aseptic Processing Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically,***
1436	21 CFR 211.42(c)(10)(vi)	2	Equipment to control conditions	Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, ***
1503	21 CFR 211.122(c)	2	Records not kept for each shipment	Records are not maintained for each shipment received of each different labeling and packaging material. Specifically, ***
1545	21 CFR 211.125(c)	2	Label reconciliation discrepancies evaluation/investigation	Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated]. Specifically, ***
1546	21 CFR 211.125(d)	2	Destruction of excess labels with lot numbers	Excess labeling bearing lot or control numbers is not destroyed. Specifically, ***
1629	21 CFR 211.130(a)	2	Prevention of cross contamination, mix-ups	There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination. Specifically, ***
1724	21 CFR 211.134(b)	2	Representative samples after completion	Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations. Specifically, ***
1726	21 CFR 211.86	2	Rotation of components/containers/closures	There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first. Specifically, ***
1803	21 CFR 211.84(b)	2	Representative Samples Criteria	The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, ***
1843	21 CFR 211.84(d)(2)	2	Component written specification	Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically,***
1874	21 CFR 211.180(a),(b)	2	Record maintenance 3 years (exempt OTC drugs)	Records for all [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of OTC drug product which is exempt from expiration dating are not maintained for 3 years after distribution of the last lot of drug product. Specifically, ***
1918	21 CFR 211.166(a)(2)	2	Stability sample storage conditions described	The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, ***
1922	21 CFR 211.166(a)(4)	2	Testing in same container - closure system	The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed. Specifically, ***
1932	21 CFR 211.167(a)	2	Sterility/pyrogen-free testing	Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements. Specifically, ***
1958	21 CFR 211.180(f)	2	Responsible firm officials notified in writing	Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, ***
2005	21 CFR 211.184(e)	2	Records of disposition of rejected material	Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling]. Specifically, ***
2011	21 CFR 211.188(a)	2	Accurate reproduction	The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed]. Specifically, ***
2200	21 CFR 211.186(b)(4)	2	Variation in the Amount of Components Used	The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form. Specifically, ***
3555	21 CFR 211.48(b)	2	Drains--Size, Back-siphonage Prevention	Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer]. Specifically, ***
3562	21 CFR 211.56(c)	2	Written procedures lacking for use of pesticides etc.	Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products]. Specifically, ***
3581	21 CFR 211.101(d)	2	Verification of component addition	Each component is not added to the batch by one person and verified by a second person.. Specifically, ***
3594	21 CFR 211.110(d)	2	Rejected in-process materials not quarantined	Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
3604	21 CFR 211.160(b)(1)	2	Determination of conformance	Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not made for each lot within each shipment of [components] [drug product containers] [closures] [labeling] used in the manufacture, processing, packing or holding of drug products. Specifically, ***
3630	21 CFR 211.170(b)	2	Drug product reserve containers	Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product]. Specifically, ***
3640	21 CFR 211.204	2	Returned drug products identified and held	Returned drug products are not [identified as such] [held]. Specifically, ***
3641	21 CFR 211.204	2	Record information inclusions	Records of returned drug products do not include the [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity] [date of disposition] [ultimate disposition]. Specifically, ***
4305	21 CFR 211.68(b)	2	Backup data not assured as exact and complete	Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***
4310	21 CFR 211.84(c)(3)	2	Sterile Equipment, Aseptic Techniques in sample collecting	Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample. Specifically, ***
4311	21 CFR 211.84(c)(4)	2	Compositing of Sub Samples	Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing. Specifically, ***
4316	21 CFR 211.84(d)(3)	2	Testing Containers & Closures Conformity with Specs	Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, ***
4323	21 CFR 211.115(a)	2	Reprocessing procedures lack steps to be taken	Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics. Specifically, ***
4329	21 CFR 211.122(b)	2	Rejection of unapproved labeling/packaging materials	Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable. Specifically, ***
4346	21 CFR 211.160(b)(1)	2	Retesting when subject to deterioration	Procedures designed to assure conformance to written specifications do not require appropriate retesting of [components] [drug product containers] [closures] subject to deterioration. Specifically, ***
4348	21 CFR 211.160(b)(2)	2	In-process materials - sampling, testing procedures	Laboratory controls do not include a description of [sampling] [testing] procedures for in-process materials. Specifically, ***
4350	21 CFR 211.160(b)(3)	2	Drug products-sampling procedures/specifications	Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, ***
4356	21 CFR 211.166(b)	2	Tentative expiration date	Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the appropriate expiration date determined. Specifically, ***
4360	21 CFR 211.170(b)	2	Reserve drug product sample quantity - all tests	The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product. Specifically, ***
4366	21 CFR 211.188(a)	2	Accurate reproduction included	Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed. Specifically, ***
4367	21 CFR 211.188(b)(13)	2	Examinations for correct labeling	Batch production and control records do not include results of examinations made of packaged and labeled products for correct labeling. Specifically, ***
4370	21 CFR 211.188(b)(10)	2	Records of any sampling performed	Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced. Specifically, ***
4387	21 CFR 211.198(a)	2	Reporting of adverse drug experience to FDA	Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration. Specifically, ***
4415	21 CFR 211.204	2	Returned drug products with doubt cast as to safety et. al.	Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters]. Specifically, ***
6705	21 CFR 310.305(c)	2	Failure to report	Adverse drug experience information has not been reported to FDA. Specifically, ***
6736	21 CFR 314.80(c)(1)(ii)	2	Submission of report follow-up	Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as requested by FDA] concerning post marketing 15-day reports. Specifically, ***
6825	21 CFR 314.80(c)(1)(iii)	2	Non-applicant reports to applicant	You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected.However, you did not submit each report to the applicant [within five calendar days of your receipt of the information]. Specifically, ***
6833	21 CFR 314.80(c)(2)(ii)	2	Incomplete periodic safety report	Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences]. Specifically, ***
10022	21 CFR 310.305(a)	2	Failure to develop written procedures	Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of postmarketing adverse drug experiences. Specifically, ***
1159	21 CFR 211.28(a)	1	Clothing appropriate for duties performed	Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, ***
1164	21 CFR 211.28(c)	1	Unauthorized Personnel in Limited Access Areas	Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas. Specifically, ***
1219	21 CFR 211.67(b)(2)	1	Cleaning SOPs/schedules	Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
1266	21 CFR 211.42(d)	1	Penicillin processing area notkept separate	The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use. Specifically,***
1384	21 CFR 211.101(c)	1	Weighing/measuring/subdividing operations	Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, ***
1413	21 CFR 211.42(c)(5)	1	Mfg / Processing Operations Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, ***
1419	21 CFR 211.42(c)(8)	1	Released Drug Products Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release. Specifically,***
1431	21 CFR 211.42(c)(10)(ii)	1	Temperature / Humidity Controls	Aseptic processing areas are deficient regarding [temperature] [humidity]controls. Specifically, ***
1449	21 CFR 211.111	1	Deviations of production time limits	Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, ***
1456	21 CFR 211.115(b)	1	Reprocessing/quality control unit	Reprocessingwasperformed without the [review] [approval] of the quality control unit. Specifically, ***
1507	21 CFR 211.122(f)	1	Gang printed labeling	Gang-printed labeling used for [different drug products] [different drug strengths of the same drug product] [different net contents of the same drug product] are not adequately differentiated by size, shape or color. Specifically, ***
1509	21 CFR 211.122(h)	1	Printing devices	Printing devices used to imprint labeling upon the drug product [unit label] [case] arenot monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
1791	21 CFR 211.80(c)	1	Storage off Floor, Spaced Suitably	Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection]. Specifically, ***
1794	21 CFR 211.80(d)	1	Disposition recorded by lot identification	The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, ***
1804	21 CFR 211.84(c)(1)	1	Containers cleaned before sampling	Procedures designed for sample collection of incoming components do not indicate that the containers of components selected shall be cleaned where necessary, by appropriate means. Specifically, ***
1845	21 CFR 211.84(d)(3)	1	Container/Closure Written Test Procedure	Drug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance withappropriate written procedures. Specifically, ***
1927	21 CFR 211.166(b)	1	Accelerated stability studies	Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies. Specifically, ***
1939	21 CFR 211.167(c)	1	Controlled release test methods written, followed	Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed]. Specifically, ***
1957	21 CFR 211.180(e)(2)	1	Review of problem drugs	The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product. Specifically, ***
1977	21 CFR 211.182	1	Dedicated equipment: records part of batch record	The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record. Specifically, ***
1979	21 CFR 211.182	1	Chronological Order of Equipment Log Entries	The entries in the equipment cleaning and use logs are not in chronological order. Specifically, ***
2001	21 CFR 211.184(b)	1	Component Test Records	The [component] [drug product container] [closure] [labeling] records do not include the [results of tests or examinations performed] [the conclusions derived from tests or examinations performed]. Specifically, ***
2014	21 CFR 211.188(b)(2)	1	Identification of Equipment and Lines	The batch production and control records are deficient in that they do notinclude the identity of major [equipment] [lines] used. Specifically, ***
2015	21 CFR 211.188(b)(3)	1	Identification of Components and In-Process Materials	The batch production and control records are deficient in that they do not include specific identification of each [batch of component] [in-process material] used. Specifically, ***
2017	21 CFR 211.188(b)(5)	1	In-Process and Laboratory Control Results	The batch production and control records are deficient in that they do notinclude [in-process] [laboratory] control results. Specifically, ***
2019	21 CFR 211.188(b)(7)	1	Documentation of Actual Yield and Theoretical Yield	The batch production and control records are deficient in that they do notinclude a statement of the [actual yield] [percentage of theoretical yield]. Specifically, ***
2022	21 CFR 211.188(b)(10)	1	Documentation of Sampling Performed	The batch production and control records are deficient in that they do not include documentation of sampling performed. Specifically, ***
2203	21 CFR 211.186(b)(7)	1	Theoretical Yield and Percentages	The master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum] [maximum] [yield percentages]. Specifically, ***
2400	21 CFR 211.194(a)(3)	1	Statement of Sample Weights and Measures	Laboratory records are deficient in that they do not include a statement of the [weight] [measure] of the sample used for testing. Specifically, ***
2402	21 CFR 211.194(a)(5)	1	Testing Calculations	Laboratory records are deficient in that they do not include all calculations performed during testing. Specifically, ***
2572	21 CFR 211.198(b)	1	Complaint File Location	Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing site nor were they readily available from their off-site location. Specifically, ***
2618	21 CFR 211.198(b)(1)	1	Complaint Record required information	Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
2620	21 CFR 211.198(b)(2)	1	Complaint Record at Location of Investigation	Complaint records are deficient in that they are not maintained at the establishment where the investigation occurred. Specifically, ***
3545	21 CFR 211.44	1	Adequate lighting not provided	Adequate lighting is not provided in all areas. Specifically, ***
3548	21 CFR 211.46(c)	1	Air filtration system lacking in production area	The production area air supply lacks an appropriate air filtration system. Specifically, ***
3551	21 CFR 211.46(d)	1	Penicillin air handling systems not kept separate	Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate from those for other drug products for human use. Specifically, ***
3563	21 CFR 211.56(c)	1	Rodenticides et. al. registration and usage	Rodenticides, insecticides and fungicides are not [registered] [used] in accordance with the Federal Insecticide, Fungicide, andRodenticide Act (7 U. S.C. 135). Specifically, ***
3573	21 CFR 211.101(b)	1	Measured components for manufacturing	Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, ***
3588	21 CFR 211.110(a)(3)	1	Mixing adequacy	The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity. Specifically, ***
3597	21 CFR 211.122(g)(3)	1	Visual inspection	The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for [100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling] [examination to be performed by one person and independently verified by a second person]. Specifically, ***
3605	21 CFR 211.160(b)(1)	1	Specification description of sample/testing	The specifications for components, drug product containers or closures and labeling are deficient in that they do not include a description of the [sampling plan] [testing procedures]. Specifically, ***
3606	21 CFR 211.160(b)(1)	1	Retesting	The specifications for [components] [drug product containers] [closure] are deficient in that they do not include appropriate retesting requirements. Specifically, ***
3607	21 CFR 211.160(b)(2)	1	Acceptance of in-process materials	Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials. Specifically, ***
3608	21 CFR 211.160(b)(2)	1	Sampling/testing of in-process materials	The specifications for in-process materials are deficient in that they do not include a description of the [sampling plan] [testing procedures] for in-process materials. Specifically, ***
3610	21 CFR 211.160(b)(3)	1	Drug product sample	Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, ***
3615	21 CFR 211.160(b)(4)	1	Test devices not meeting specifications	Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used. Specifically, ***
3631	21 CFR 211.170(b)	1	Investigation of reserve sample deterioration	Evidence of reserve drug product sample deterioration was not[investigated] [recorded and maintained with other stability data]. Specifically, ***
3638	21 CFR 211.182	1	Lots on dedicated equipment are sequential	Lots or batches of a product produced on dedicated equipment, and not entered into individual equipment logs, [do not follow in numerical order] [are not manufactured in numerical sequence]. Specifically, ***
4313	21 CFR 211.84(c)(6)	1	Containers Marked to Show Samples Taken	Containers from which samples have been taken are not marked to show that samples have been taken from them. Specifically, ***
4321	21 CFR 211.101(b)	1	Identification of new containers	For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number]. Specifically, ***
4327	21 CFR 211.122(c)	1	Records fail to include	Records kept for each different labeling and packaging material shipment fail to include [the receipt] [results of examination or testing] [a statement of whether the shipment was accepted or rejected]. Specifically, ***
4337	21 CFR 211.150(a)	1	Distribution of oldest stock first	Distribution procedures do not include a procedure whereby the oldest approved stock of a drug product is distributed first. Specifically, ***
4345	21 CFR 211.160(b)(1)	1	Samples (various types) representative, identified properly	Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified]. Specifically, ***
4362	21 CFR 211.170(a)(3), (b)(3)	1	Retention time for exempt OTC drug products	Reserve samples for [active ingredients in OTC drug products] [OTC drug products] which are exempt from bearing an expiration date are not retained for 3 years after the lot or batch of drug product is distributed. Specifically, ***
4364	21 CFR 211.176	1	Failing to test for penicillin cross-contamination	Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin. Specifically, ***
4371	21 CFR 211.188(b)(9)	1	Description of containers and closures	Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced. Specifically, ***
4384	21 CFR 211.198(b)	1	Records maintained for 3 years (exempt OTC drugs)	Written complaint file records for OTC drugs lacking expiration dating because they meet the criteria for exemption, are not maintained for 3 years after distribution of the drug product. Specifically, ***
4394	21 CFR 211.186(b)(3)	1	Components complete listing	The master production and control records do not include a complete list of components [designated by names or codes sufficiently specific to indicate any special quality characteristics]. Specifically, ***
4395	21 CFR 211.186(b)(4)	1	Weight or measure of each component	The master production and control records lack an accurate statement of the [weight][measure] of each component [using the same weight system for each component]. Specifically, ***
4398	21 CFR 211.186(b)(6)	1	Weight or measure at stages of processing	The master production and control records lack a statement of theoretical weight or measure at appropriate stages of processing. Specifically, ***
4405	21 CFR 211.194(a)(2)	1	Statement of methods and data	Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested]. Specifically, ***
4408	21 CFR 211.194(a)(3)	1	Weight or measure of sample	Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate. Specifically, ***
4416	21 CFR 211.204	1	Reprocessed returned drug products	Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity. Specifically, ***
6735	21 CFR 314.80(c)(1)(ii)	1	Failure to investigate serious, unexpected events	Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, ***
6838	21 CFR 314.80(e)(1)	1	Failure to report post-marketing study ADEs	Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience. Specifically, ***
6842	21 CFR 314.80(i)	1	Failure to maintain records	Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period. Specifically, ***
8914	21 CFR 314.81(b)(2)(iv)(b)	1	Mfg and control changes not requiring a supplemental app.	An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented. Specifically, ***
8922	21 CFR 314.81(b)(2)(viii)	1	Post marketing study status report for other studies	An annual report did not include a status report for all post marketing studies being performed by, or on behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii). Specifically, ***
8935	FDCA 760(b)(1)	1	Failure of responsible person to report AE (non-RX Drug)	Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, ***
8938	FDCA 760(c)(1)	1	Timing of AE report submission (non-RX drugs)	An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS within 15 business days of receipt of the report.
10021	21 CFR 314.98(a)	1	(Flag to indicate ANDA applicant)	(DO NOT PRINT ON FDA 483. This cite is to be used as a flag to indicate that the recipient of an FDA 483 involving ADE reporting is the applicant for one or more approved ANDAs, as opposed to approved NDAs.No specifics text is required for this cite.)

Bioresearch Monitoring

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Bioresearch monitoring	7560	21 CFR 312.60	137	FD-1572, protocol compliance	An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***
	7530	21 CFR 312.62(b)	95	Case history records- inadequate or inadequate	Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***
	7281	21 CFR 56.108(a)(1)	36	Initial and continuing reviews	The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
	7318	21 CFR 56.115(a)(2)	34	Minutes of IRB meetings	Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***
	7498	21 CFR 312.66	23	Unanticipated problems	Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***
	7526	21 CFR 312.62(a)	22	Accountability records	Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***
	7334	21 CFR 56.115(a)(5)	21	List of members	A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***
	7562	21 CFR 312.60	15	Informed consent	Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests] . Specifically, ***
	7227	21 CFR 50.27(a)	13	Consent form not approved/signed/dated	Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject’s legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***
	7278	21 CFR 56.107(e)	13	Conflict of interest	The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest. Specifically, ***
	7290	21 CFR 56.108(c)	13	Members present for review	For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***
	7482	21 CFR 312.50	12	General responsibilities of sponsors	Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***
	7552	21 CFR 312.66	12	Changes in research	Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***
	7517	21 CFR 312.66	10	Initial and continuing review	Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***
	7293	21 CFR 56.109(f)	9	Continuing review	The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year]. Specifically, ***
	7317	21 CFR 56.115(a)(1)	9	Copies of all research proposals and related documents	Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects]. Specifically, ***
	7335	21 CFR 56.115(a)(6)	9	Written procedures per 56.108(a) and (b)	Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***
	7342	21 CFR 56.108(b)(2)	8	Prompt reporting of noncompliance	The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with theses regulations or the requirements or determinations of the IRB. Specifically, ***
	7368	21 CFR 56.108(a)2)	8	More frequent reviews, verification of no changes	The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, ***
	7371	21 CFR 56.108(a)(1)	8	Reporting findings and actions to investigator/institution	The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution]. Specifically, ***
	7391	21 CFR 50.25(a)(5)	8	Confidentiality, FDA inspection of records	There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically, ***
	7654	21 CFR 56.110(b)	8	Research not eligible for expedited review	The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year]. Specifically, ***
	7231	21 CFR 50.20	7	Consent not obtained, exceptions do not apply	Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***
	7286	21 CFR 56.108(b)(1)	7	Prompt reporting of unanticipated problems	The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others. Specifically, ***
	4007	21 CFR 58.130(a)	6	Conduct: in accordance with protocol	Not all nonclinical laboratory studies were conducted in accordance with the protocol. Specifically, ***
	7209	21 CFR 50.25(a)(1)	6	Procedures, identification of those which were experimental	The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***
	7321	21 CFR 56.110(c)	6	Method to keep members advised	The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***
	3914	21 CFR 58.31(f)	5	Management: personnel understand their functions	Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***
	3920	21 CFR 58.33(c)	5	Study director: unforeseen circumstances	The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***
	7343	21 CFR 56.108(b)(3)	5	Reporting of suspension/termination	The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval . Specifically, ***
	7479	21 CFR 312.56(a)	5	Monitoring investigations	Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***
	3931	21 CFR 58.35(b)(5)	4	QAU: authorize deviations from protocols or SOPs	The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation. Specifically, ***
	3957	21 CFR 58.81(a)	4	SOPs: laboratory methods	The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***
	7305	21 CFR 56.110(b)(2)	4	Minor changes	The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature. Specifically, ***
	7316	21 CFR 56.115(a)(4)	4	Copies of IRB/CI correspondence	Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***
	7320	21 CFR 56.109(e)	4	IRB approvals/disapprovals - general	The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity. Specifically, ***
	7337	21 CFR 56.115(b)	4	Retention of records	Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***
	7480	21 CFR 312.50	4	Ensuring compliance with plan and protocol	Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***
	7520	21 CFR 312.64(b)	4	Safety reports	Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***
	7543	21 CFR 312.61	4	Unauthorized recipients (investigator)	A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. Specifically, ***
	3902	21 CFR 58.29(a)	3	Personnel: education, training, experience	Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***
	3912	21 CFR 58.31(d)	3	Management: testing of test and control articles	Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. Specifically, ***
	3918	21 CFR 58.33(a)	3	Study director: follow study protocol	The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***
	3919	21 CFR 58.33(b)	3	Study director: all data recorded and verified	The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***
	3932	21 CFR 58.35(b)(6)	3	QAU: review final study report	The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***
	3960	21 CFR 58.81(b)	3	SOPs: required	Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals]. Specifically, ***
	4035	21 CFR 58.190(a)	3	Archives: data, documentation, specimens	Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***
	7274	21 CFR 56.107(a)	3	At least five members with varying backgrounds	The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution]. Specifically, ***
	7319	21 CFR 56.115(a)(3)	3	Records of continuing review	Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
	7339	21 CFR 56.108(a)(4)	3	Changes in approved research	The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB approval had already been given, would not be initiated without IRB review and approval (except where necessary to eliminate apparent immediate hazards to the human subjects).
	7353	21 CFR 50.52	3	Factors required for approval	The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being. However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55]. Specifically, ***
	7369	21 CFR 56.109(h)	3	Children as subjects	The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50 Subpart D, "Additional Safeguards for Children in Clinical Investigations." Specifically, ***
	7378	21 CFR 50.27(a)	3	Copy of consent form not provided	A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent. Specifically, ***
	7388	21 CFR 50.25(a)(2)	3	Reasonably foreseeable risks or discomforts	The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***
	7527	21 CFR 312.62(a)	3	Unused drug disposition (investigator)	Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions]. Specifically, ***
	7531	21 CFR 312.62(c)	3	Record retention	Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***
	7652	21 CFR 56.113	3	Reporting	The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***
	3909	21 CFR 58.31(a)	2	Management: designating the study director	Testing facility management failed to designate a study director before each study was initiated. Specifically, ***
	3917	21 CFR 58.33	2	study director: overall study responsibility	The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control. Specifically, ***
	3922	21 CFR 58.33(e)	2	Study director: follow GLP regulations	The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
	3924	21 CFR 58.35(a)	2	QAU: monitor facilities, etc.	The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***
	3926	21 CFR 58.35(b)(1)	2	QAU: maintain a master schedule	The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***
	3953	21 CFR 58.63(a)	2	Equipment: inspection, cleaning and maintenance	Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
	3954	21 CFR 58.63(a)	2	Equipment: calibration	Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***
3955	21 CFR 58.63(b)	2	Equipment: maintenance SOPs	The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate. Specifically, ***
3956	21 CFR 58.63(c)	2	Equipment: maintenance records	Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***
3958	21 CFR 58.81(a)	2	SOPs: authorization and documentation of deviations	Not all deviations from standard operating procedures in a study were authorized by the study director and documented in the raw data. Specifically, ***
3977	21 CFR 58.90(g)	2	Animal care: analysis of feed and water	Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***
4025	21 CFR 58.185(a)(9)	2	Final report: circumstances affecting data qual., integrity	The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***
7304	21 CFR 56.110(b)(1)	2	No more than minimal risk	The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects. Specifically, ***
7328	21 CFR 56.111(b)	2	Vulnerable subject safeguards	The IRB approved the conduct of research in a situation where some or all of the subjects were likely to be vulnerable to coercion or undue influence, but did not determine that additional safeguards had been included in the study to protect the rights and welfare of those subjects. Specifically, ***
7340	21 CFR 56.108(a)(3)	2	Prompt reporting of changes	The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity. Specifically, ***
7363	21 CFR 50.55(f)	2	Documentation of permission by parents or guardian	Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27. Specifically, ***
7370	21 CFR 56.111(c)	2	Children as subjects	The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D. Specifically, ***
7392	21 CFR 50.25(a)(7)	2	Whom to contact	The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and research subjects' rights] [in the event of a research-related injury to the subject]. Specifically, ***
7393	21 CFR 50.25(a)(8)	2	Participation; refusal and discontinuance	The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled]. Specifically, ***
7411	21 CFR 312.53(c)(1)	2	Investigator statement (FDA 1572)	Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***
7453	21 CFR 312.56(b)	2	Investigator non-compliance	An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***
7456	21 CFR 312.57(d)	2	Bioequivalence samples	Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were not [retained] [released to FDA upon request as required by 21 CFR Part 320.138]. Specifically, ***
7518	21 CFR 312.64(d)	2	Financial info	Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor. Specifically, ***
7634	21 CFR 312.7(a)	2	Promotion of Investigational Drug	Representations were made in a promotional context that the investigational drug is [safe] [effective] for the purposes for which it is under investigation. Specifically, ***
7656	21 CFR 56.108(c)	2	Approval from a majority of members present	For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present. Specifically, ***
7666	21 CFR 50.20	2	Understandable language	The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***
3900	21 CFR 58.10	1	Notifying contractor of GLP status	Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations. Specifically, ***
3903	21 CFR 58.29(b)	1	Personnel: summary of training, job description	The testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically, ***
3911	21 CFR 58.31(c)	1	Management: assure there is a QAU	Testing facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations. Specifically, ***
3915	21 CFR 58.31(g)	1	Management: QAU findings to study director	Testing facility management failed to assure that any deviations from FDA GLP regulations reported by the quality assurance unit were communicated to the study director and corrective actions were taken and documented. Specifically, ***
3923	21 CFR 58.33(f)	1	Study director: transfer of data to archives	The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***
3927	21 CFR 58.35(b)(2)	1	QAU: maintain copies of all protocol	The quality assurance unit failed to maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. Specifically, ***
3929	21 CFR 58.35(b)(3)	1	QAU: problems affecting study integrity	The quality assurance unit failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity. Specifically, ***
3930	21 CFR 58.35(b)(4)	1	QAU: submit periodic status reports	The quality assurance unit failed to periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. Specifically, ***
3938	21 CFR 58.43(a)	1	Facility: adequate number of animal rooms or areas	The testing facility does not have a sufficient number of animal rooms or areas, as needed, to assure proper [separation of species or test systems] [isolation of individual projects] [quarantine of animals] [routine or specialized housing of animals]. Specifically, ***
3949	21 CFR 58.47(b)	1	Facility: article storage separate from test system	The testing facility does not provide storage areas for the test and control article and test and control mixtures [separate from areas housing the test systems] [adequate to preserve the identity, strength, purity, and stability of the articles and mixtures]. Specifically, ***
3951	21 CFR 58.51	1	Facility: archives	Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***
3952	21 CFR 58.61	1	Equipment: appropriate design and adequate capacity	Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically, ***
3961	21 CFR 58.81(c)	1	SOPs: availability	Not all laboratory areas have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Specifically, ***
3962	21 CFR 58.81(d)	1	SOPs: historical file	A historical file of standard operating procedures, and all revisions, including the dates of such revisions, was not maintained. Specifically, ***
3964	21 CFR 58.83	1	Reagents: outdated	Deteriorated or outdated reagents and solutions were used. Specifically, ***
3983	21 CFR 58.105(a)	1	Test article: characterization	The identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately defined and documented. Specifically, ***
3989	21 CFR 58.107	1	Test article: handling	Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***
3993	21 CFR 58.120(a)	1	Protocol: approved	Not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study. Specifically, ***
4012	21 CFR 58.130(e)	1	Conduct: date and sign	Not all data entries were dated on the date of entry and signed or initialed by the person entering the data. Specifically, ***
4016	21 CFR 58.185(a)	1	Final report: non-existent	A final report was not prepared for each nonclinical laboratory study. Specifically, ***
4017	21 CFR 58.185(a)(1)	1	Final report: name, address, dates	The final study report did not include the name and address of the facility performing the study and the dates on which the study was initiated and completed. Specifically, ***
4028	21 CFR 58.185(a)(12)	1	Final report: reports of individual scientists	The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study.
4032	21 CFR 58.185(c)	1	Final report: corrections or additions	'Not all corrections or additions to a final report were in the form of an amendment by the study director. Specifically, ***
4036	21 CFR 58.190(b)	1	Archives: orderly storage, expedient retrieval	Archives failed to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Specifically, ***
4037	21 CFR 58.190(b)	1	Archives: conditions of storage	Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time period of their retention and the nature of the [documents] [specimens]. Specifically, ***
4041	21 CFR 58.190(e)	1	Archives: indexing, expedient retrieval	Not all material retained or referred to in the archives was indexed to permit expedient retrieval. Specifically, ***
4042	21 CFR 58.195(b)	1	Archives: retention for appropriate time	Not all required documentation records, raw data, and specimens pertaining to a nonclinical laboratory study were retained in the archives for the appropriate time. Specifically, ***
4049	21 CFR 58.195(h)	1	Archives: notification of FDA of transfer	The Food and Drug Administration was not notified in writing of the transfer of all raw data, documentation, and other required material pertaining to a nonclinical laboratory study when the laboratory facility went out of business. Specifically, ***
7276	21 CFR 56.107(c)	1	One scientific and one non-scientific member	The IRB does not include [at least one member whose primary concerns are in the scientific area] [at least one member whose primary concerns are in nonscientific areas]. Specifically, ***
7277	21 CFR 56.107(d)	1	One non-affiliate member	The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***
7279	21 CFR 56.107(f)	1	Invited individual allowed to vote with IRB	The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB. Specifically, ***
7297	21 CFR 56.109(b)	1	Information given to subjects	The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent. Specifically, ***
7298	21 CFR 56.109(a)	1	Authority of the IRB	he IRB does not have the authority to [approve] [require modifications in] [disapprove] all research activities covered by the regulations. Specifically, ***
7309	21 CFR 56.111(a)(1)	1	Risks minimized by sound research design	The IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were consistent with sound research design and which did not unnecessarily expose subjects to risk. Specifically, ***
7323	21 CFR 56.111(a)(3)	1	Selection of subjects equitable	The IRB approved the conduct of research, but did not determine that the selection of subjects was equitable. Specifically, ***
7324	21 CFR 56.111(a)(4)	1	Informed consent sought	The IRB approved the conduct of research, but did not determine that informed consent would be sought from each prospective subject or the subject's legally authorized representative, to the extent required by 21 CFR 50. Specifically, ***
7325	21 CFR 56.111(a)(5)	1	Informed consent documented	The IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented. Specifically, ***
7372	21 CFR 56.115(b)	1	Access to records	Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the FDA. Specifically, ***
7376	21 CFR 56.109(e)	1	IRB disapprovals not involving IC exception	When the IRB disapproved proposed research, it did not [notify the investigator in writing] [provide a statement of reasons for the decision] [give the investigator an opportunity to respond in person or in writing]. Specifically, ***
7380	21 CFR 50.27(b)(2)	1	Short form: IRB approval of oral presentation	The IRB did not approve a written summary of what was to be said to the subject or the subject's legally authorized representative, in a situation where a short form written consent document was prepared. Specifically, ***
7381	21 CFR 50.27(b)(2)	1	Short form: Summary copy not signed/given	In a situation where a short form written consent document was prepared, a copy of the summary of what was to be said to the subject or the subject's legally authorized representative [was not signed by the witness] [was not signed by the person actually obtaining the consent] [was not given to the subject or the subject's legally authorized representative (in addition to a copy of the short form)]. Specifically, ***
7384	21 CFR 50.25(b)(1)	1	Statement of risks	The informed consent document did not contain a statement that the test article or procedure might involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. Specifically, ***
7387	21 CFR 50.25(a)(1)	1	Statement of research, purpose, duration of participation	The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation]. Specifically, ***
7390	21 CFR 50.25(a)(4)	1	Alternate procedures, courses of treatment	There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***
7405	21 CFR 56.109(f)	1	Authority to observe consent process and research	The IRB does not have the authority to observe or have a third party observe the consent process and the research. Specifically, ***"
7410	21 CFR 312.53(a)	1	Investigator selection	Investigators who were not qualified by training and experience as appropriate experts were selected to investigate a drug. Specifically, ***
7483	21 CFR 312.55(b)	1	New observations, adverse effects and risks	Not all participating investigators were [promptly] informed of new observations discovered by or reported to the sponsor [with respect to adverse effects and safe use]. Specifically, ***
7488	21 CFR 312.59	1	Records of unused drug disposition	Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57. Specifically, ***
7507	21 CFR 312.52(a)	1	Transfer of obligations	Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, ***
7545	21 CFR 312.120(c)	1	Foreign clinical trials	Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the ``Declaration of Helsinki''] [the laws and regulations of the country in which the research was conducted]. Specifically, ***
7546	21 CFR 312.64(d)	1	Financial info update	Updated financial information was not provided to the study sponsor when relevant changes occurred during [the course of the investigation] [the year following completion of the study]. Specifically, ***
7558	21 CFR 312.57(c)	1	Record retention requirement	Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically, ***
7629	21 CFR 312.56(c)	1	Annual report	Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically, ***
7635	21 CFR 312.7(b)	1	Commercial distribution of an investigational drug	The investigational new drug was [commercially distributed] [test marketed]. Specifically, ***
7636	21 CFR 312.7(d)	1	Charging for Investigational Drugs	Charges were made for the investigational drug without the prior written approval of FDA. Specifically, ***
7659	21 CFR 50.25(a)(6)	1	Compensation, medical treatment in event of injury	For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained]. Specifically, ***
7664	21 CFR 50.20	1	Circumstances of obtaining consent	The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***
7678	21 CFR 56.106(a)	1	IRB for CI's regulated under 505(i) or 520(g)	An individual authorized to act on the behalf of an IRB reviewing clinical investigations regulated by FDA under [section 505(i)] [section 520(g)] of the FDC act has not submitted registration information
7682	21 CFR 56.106(b)(1)	1	Senior officer (IRB overseer) information	Registration information does not include the [name] [mailing address] [phone number] [facsimile number] [electronic mail address] of the senior officer of the institution operating the IRB who is responsible for overseing activities performed by the IRB. Specifically, ***
7692	21 CFR 56.106(e)	1	Changes in contact or chairperson information	The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change. Specifically, ***

Veterinary medicine

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Veterinary medicine	4185	FDCA 402(a)(4)	167	Record keeping	Treatment records were not [maintained] [complete]. Specifically,***
	4093	21 CFR 530.11(d)	107	Tissue residue	Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling. Specifically, ***
	7001	FDCA 402(a)(4)	83	Drug inventory	You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, ***
	1360	FDCA 501(a)(5)	44	Expired drugs	Expired drug(s) were observed in the drug storage area. Specifically, ***
	13509	FDCA 402(a)(4)	39	Identity of animals	Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the animal(s) that you [purchased] [transported] and delivered for [sale] [consignment] at [an auction yard] [a slaughter plant]. Specifically, ***
	4182	FDCA 501(a)(5)	38	Extra label use w/o veterinary client-patient relationship	Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship. Specifically, ***
	4298	21 CFR 530.11(a)	31	Rx not followed	Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment] [route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary directions]. Specifically, ***
	4097	21 CFR 530.20(a)(2)(iv)	25	Tissue residue	Causing an illegal residue in a food-producing animal of an approved human or animal drug through [prescribing the use of] [using] the drug contrary to its labeling, and failing to take appropriate measures to assure that [assigned timeframes for withdrawal were met] [no illegal residue would occur]. Specifically, ***
	1442	FDCA 402(a)(4)	23	Records review prior to slaughter	Failure to systematically review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed. Specifically, ***
	1366	21 CFR 530.11(a)	22	Dosage level	Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
	13521	21 CFR 530.41(a)	21	Drugs prohibited for extralabel use in food producing animal	A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing animal(s). Specifically, ***
	4186	FDCA 402(a)(4)	20	System for administration of drugs	Failure to have a system to control administration of drug treatments to your animals. Specifically, ***
	13508	FDCA 402(a)(4)	15	Medication status of animals	Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and delivered for [sale] [consignment] at[an auction yard] [a slaughter plant]. Specifically, ***
	1362	21 CFR 530.11(a)	14	Species or class	Administration of an approved human or animal drug to a [species of animal] [class of animal] for which the drug was not labeled, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
	1373	21 CFR 530.11(a)	14	Route of administration	Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous] [subcutaneous] [topical] [intramammary] [intrauterine], which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
	1389	21 CFR 530.11(a)	11	Withdrawal period	Administration of an approved animal drug contrary to the labeling, without benefit of a valid veterinarian-client-patient relationship, in that pre-slaughter withdrawal time was not observed. Specifically, ***
	1446	FDCA 402(a)(4)	11	Hospital pen	Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
	1457	FDCA 402(a)(4)	10	Feeding colostrum	Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
	1811	21 CFR 225.58(b)(1)	9	Three assays per year	Periodic assays are not performed during the calendar year on at least three representative samples of medicated feeds requiring a medicated feed mill license, for each drug or drug combination used. Specifically, ***
	4094	21 CFR 530.11(b)	8	Use in animal feed	An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
	1376	21 CFR 530.11(a)	7	Frequency and duration	Administration of an approved animal drug [more frequently] [for a longer time period] than specified in the labeling, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
	1493	21 CFR 225.30(b)(4)	7	Calibration of scales and metering devices	Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation] [as frequently as necessary] to insure their accuracy. Specifically, ***
	1765	21 CFR 225.42(b)(6)(i) - (v)	7	Information required	Daily inventory records for each drug used do not include [the quantity of drug on hand at the beginning and end of the work day] [the amount of each drug used, sold, or otherwise disposed of] [the batches or production runs of medicated feed in which each drug was used] [information concerning any semiprocessed intermediate mix to be used in a medicated feed] [the action taken to reconcile any discrepancies in the inventory record]. Specifically, ***
	2076	21 CFR 225.102(b)(1)	6	Elements of the MRF	The Master Record File does not contain [the name of the medicated feed] [the name and weight percentage or measure of each drug or drug combination and each nondrug ingredient to be used in manufacturing a stated weight of medicated feed] [a copy or description of the label that will accompany the medicated feed] [manufacturing instructions or reference thereto that have been determined to yield a properly mixed medicated feed of the specified formula for each medicated feed produced][appropriate control directions including the collection of samples for specified laboratory assays] [the basis for estimating quantity produced, where actual yield cannot be accurately determined when finished feed is stored in bulk]. Specifically, ***
	4183	FDCA 501(a)(5)	6	Frequency of administration	Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed]. Specifically, ***
	4184	FDCA 501(a)(5)	6	Conditions of use	Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
	4545	21 CFR 225.120	6	Vermin and pest infestation	Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***
	4111	21 CFR 530.12(c)	5	Directions for use	Failure to provide labeling containing directions for use as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
	4132	21 CFR 589.2000(d)(1)	5	Protein blenders, feed manufacturers, distributors	Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***
	1482	21 CFR 225.30(b)(1)	4	Capability to produce a medicated feed	Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, ***
	4131	21 CFR 589.2000(c)(1)(i)	4	Renderers	Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***
	4552	21 CFR 225.142	4	Adequate procedures for Type A and Type B articles	Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory control (receipt and use)] of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds. Specifically, ***
	13567	21 CFR 589.2001(c)(2)(iv)	4	Label "Do not feed to animals"	Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals". Specifically,***
	1575	21 CFR 225.42(b)(4)	3	Integrity and identity	Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***
	1782	21 CFR 225.42(b)(7)	3	Daily comparison, actual vs theoretical	A daily comparison is not made between the actual amount of drug used and the theoretical amount of drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds manufactured. Specifically, ***
	4100	21 CFR 530.20(a)(2)(iii)	3	Identity of treated animals	Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed or dispensed an approved human or animal drug contrary to the drug's labeling. Specifically, ***
	4541	21 CFR 225.42(b)	3	Adequate procedures established	Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid in assuring their identity, strength, quality and purity when incorporated into products. Specifically, ***
	4542	21 CFR 225.102((a)	3	Lack of Production Record(s)	Failure to have production record(s) for specific products which include the complete history of each batch or production run. Specifically, ***
	4557	21 CFR 225.158	3	Investigation and corrective action	Results of laboratory assays of drug components indicated that medicated feed was not in accord with the permissible limits, and no [investigation] [corrective action] was implemented immediately. Specifically, ***
	4560	21 CFR 225.165	3	Establishment and use of adequate procedures	Adequate procedures are not [established] [used] for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds. Specifically, ***
	13534	21 CFR 511.1(b)(7)(ii)	3	Records: Maintenance	Complete records of the investigation were not maintained. Specifically, ***
	13569	21 CFR 589.2001(c)(2)(vi)	3	Tracking records: establish, maintain, make available	Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed. Specifically,***
	1466	21 CFR 225.20(b)(2)	2	Maintained in clean and orderly condition	Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
	1760	21 CFR 225.42(b)(6)	2	Lot number or shipment I.D. number	The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification number]. Specifically, ***
	1821	21 CFR 225.58(b)(1)	2	First batch assay	No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license. Specifically, ***
	1850	21 CFR 225.58(d)	2	Assay results out of specification	Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective action] when assay results show medicated feeds [not in accord with label specifications] [not within permissible assay limits]. Specifically,***
	1951	21 CFR 225.80(b)(1)	2	Receipt, handling, and storage	The [labels] [labeling] [placards] are not [received] [handled] [stored] in a manner to prevent mix-ups and assure correct labeling is employed for the medicated feed. Specifically, ***
	1955	21 CFR 225.80(a)	2	Appropriate labeling for medicated feed	Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the article is safe and effective for its intended purpose. Specifically, ***
	2075	21 CFR 225.102(b)(1)	2	Preparation of MRF	AMaster Record File providing the complete procedure for manufacturing a specific productis not [prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***
	2098	21 CFR 225.102(b)(4)	2	Discrepancies investigated, reported	When significant discrepancies were noted on the batch production records, there was a failure to [institute an investigation immediately] [describe the corrective action taken on the production record]. Specifically, ***
	4454	21 CFR 225.20(a)	2	Facilities features	The features of the facility necessary for the proper manufacture of medicated feeds fail to provide for [ease of access to structures and equipment for routine maintenance] [ease of cleaning of equipment and work areas] [facilities to promote personal hygiene] [structural conditions for control of vermin and pests] [adequate space for the orderly receipt and storage of drugs and feed ingredients] [adequate space for the controlled flow of materials through the processing and manufacturing operations] [equipment necessary for the accurate packaging and delivery of a medicated feed of specified labeling and composition]. Specifically, ***
	13532	21 CFR 511.1(b)(7)(ii)	2	Records: Test article accountability	Complete records of the receipt and disposition of each shipment or delivery of the test article were not maintained by the investigator. Specifically, ***
	13541	FDCA 501(a)(5)	2	Use of veterinary prescription drugs without a prescription	Administration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. Specifically, ***
	13566	21 CFR 589.2001(c)(2)(iii)	2	Cross contamination of cattle materials	Failure to provide for measures to avoid cross-contamination by use of [separate equipment] [separate containers] once cattle materials prohibited in animal feed have been separated from other cattle materials. Specifically,***
	13568	21 CFR 589.2001(c)(2)(v)	2	Marking with readily detected agent	Failure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with an agent that can be readily detected on visual inspection. Specifically,***
	13574	21 CFR 589.2001(c)(3)(i)	2	Adequacy of records from firms supplying segregated material	Records concerning suppliers which have segregated cattle materials prohibited for use in feed fail to demonstrate [that such suppliers have adequate procedures in place to effectively exclude prohibited cattle materials] [certification or other documentation which includes a description of the segregation procedures] [documentation that the segregation procedures were in place prior to supplying any cattle material] [records of periodic review of the supplier's certification or other documentation] [documentation of an alternative method acceptable to FDA for verifying that the suppliers have effectively excluded cattle materials prohibited in animal feed]. Specifically,***
	1254	21 CFR 225.10(b)(1)	1	Training	Employees involved in the manufacture of medicated feeds lack an understanding of the manufacturing or control operations which they perform. Specifically, ***
	1262	21 CFR 225.10(b)(2)	1	Evaluation and supervision of employees	Failure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds. Specifically, ***
	1447	FDCA 402(a)(4)	1	Feeding areas	Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids. Specifically, ***
	1469	21 CFR 225.20(b)(3)	1	Pest access minimized	The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
	1638	21 CFR 225.42(b)(5)	1	Elements of receipt record	Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's lot number or other identifying number] [date of receipt] [condition of the drug when received] [return of any damaged drugs] for each lot of drug received. Specifically, ***
	1744	21 CFR 225.42(b)(6)	1	Daily inventory record kept	Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***
	1826	21 CFR 225.58(b)(1)	1	Alternatetesting of drugs in combination	Where only one drug is assayed in a medicated feed containing a combination of drugs, there was a failure to test a different drug from the one(s) previously tested during the calendar year. Specifically,***
	1923	21 CFR 225.65(b)	1	Reasonable and effective procedures followed	All equipment that comes in contact with [active drug components] [feeds in process] [finished medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed. Specifically, ***
1925	21 CFR 225.65(b)(2)	1	Flush material handling	Material used for cleanout by flushing is not properly [identified] [stored] [used in a manner] to prevent unsafe contamination of other feeds. Specifically, ***
1930	21 CFR 225.65(b)(3)	1	Sequential production	Sequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs. Specifically, ***
2074	21 CFR 225.102(a)	1	Lack of MRF	Failure to have aMaster Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product. Specifically, ***
2093	21 CFR 225.102(b)(2)(i)-(iv)	1	Elements of production record(s)	Production record(s) fail to include [the product identification] [the date of production] [a written endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of drug components used] [the theoretical quantity of medicated feed to be produced] [the actual quantity of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based on the basis for the estimate in the MRF]. Specifically, ***
2097	21 CFR 225.102(b)(4)	1	Daily review of production records	The batch production records are not checked by a responsible individual at the end of the working day to determine whether all required production steps have been performed. Specifically, ***
2189	21 CFR 225.110(b)(1)	1	Distribution record elements	Distribution record(s) for medicated feeds fail to include the [date of shipment] [name and address of purchaser] [quantity shipped] [name of the medicated feed] [lot, control number, date of manufacture, or other suitable identification]. Specifically, ***
2247	21 CFR 226.20	1	Insecticides and fungicides produced in same work areas	The work areas and equipment used for [production] [packaging] [labeling] [storage] of Type A medicated articles and their components are also used for the production, mixing or storageof finished or unfinished [insecticides] [fungicides] [rodenticides] [pesticides or their components]. Specifically, ***
2414	21 CFR 226.80(a)(4)	1	Lot number on label	Packaging and labeling operations fail to provide assurance that Type A medicated articles are labeled with lot or control numbers that permit determination of the history of the batch. Specifically, ***
4099	21 CFR 530.20(a)(2)(ii)	1	Extended withdrawal period	A substantially extended withdrawal period, supported by appropriate scientific information, was not established for the use of an approved drug in a food-producing animal, in an extralabel manner. Specifically, ***
4101	21 CFR 530.20(a)(1)	1	Approved drug available	Failure to determine that an approved animal drug was clinically ineffective for its intended use in a food-producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the drug's labeling. Specifically, ***
4108	21 CFR 530.12(a)	1	Name and address - drug dispensed by veterinarian	Failure to provide labeling showing the name and address of the prescribing veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4109	21 CFR 530.12(a)	1	Name and address - drug dispensed by pharmacist	Failure to provide labeling showing the [name of the prescribing veterinarian] [name and address of the dispensing pharmacist] for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4110	21 CFR 530.12(b)	1	Names of active ingredients	Failure to provide labeling showing the established name of each active ingredient for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4113	21 CFR 530.12(e)	1	Withdrawal, withholding, or discard time	Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4137	21 CFR 589.2000(d)(1)	1	Maintaining records	Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution. Specifically, ***
4138	21 CFR 589.2000(d)(1)	1	Records available for inspection	Failure to make copies of records maintained pursuant to 21 CFR 589.2000(c)(1)(ii) available for inspection and copying by FDA. Specifically, ***
4146	21 CFR 589.2000(e)(1)	1	Written clean-out procedures	Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***
4297	21 CFR 226.42(a)	1	Components receiving, testing, handling, et. al.	Drug components used in the manufacture and processing of Type A medicated articles are not [received] [examined or tested] [stored] [handled] [controlled] in a manner to maintain the [integrity] [identification] of such articles. Specifically, ***
4453	21 CFR 225.10(b)(1)	1	Employees lack understanding	All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment]. Specifically, ***
4547	21 CFR 225.130	1	Cleanliness, inspection, cleanout	Equipment for producing medicated feeds of intended potency and purity is not [maintained in a reasonably clean and orderly manner] [designed, constructed, installed and maintained so as to facilitate inspection and use of cleanout procedures]. Specifically, ***
4548	21 CFR 225.130	1	Scales and metering devices	The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose. Specifically, ***
4553	21 CFR 225.142	1	Packaged Type A and Type B designated areas	The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers]. Specifically, ***
4555	21 CFR 225.142	1	Use in accord with directions	All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***
4564	21 CFR 225.180	1	Bagged or bulk deliveries	All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used. Specifically, ***
13533	21 CFR 511.1(b)(7)(ii)	1	Records: Retention - investigator	Complete records of the investigation were not retained for two years by the investigator after termination of the investigation or approval of the new animal drug application. Specifically, ***
13539	21 CFR 511.1(b)(4)	1	No NCIE submitted	A Notice of Claimed Investigational Exemption for a New Animal Drug (NCIE) was not submitted prior to the shipment of that drug for clinical testing. Specifically, ***
13558	21 CFR 589.2001(c)(1)	1	Cattle 30 months and older used in feed	Animal feed or feed ingredients are manufactured from, processed with, or otherwise contain material prohibited material from cattle not inspected and passed for human consumption that are 30 months of age or older and from which brains and spinal cords were not [effectively removed] [effectively excluded]. Specifically,***
13565	21 CFR 589.2001(c)(2)(ii)	1	Renderer's maintaining adequate written procedures	Failure to maintain adequate written procedures specifying how the process of [removing the brain and spinal cord from cattle not inspected and passed for human consumption] [separating animals based on whether or not they are 30 months of age or older] is carried out. Specifically,***
13571	21 CFR 589.2001(c)(3)(i)	1	Records:establish, maintain, make available	Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, cattle materials prohibited in animal feed. Specifically,***
13576	21 CFR 589.2001(e)	1	Inspection records retention	Failure to keep for a minimum of 1 year, records required to be made availabe for inspection and copying by the FDA. Specifically,***
13578	21 CFR 589.2001(c)(1)	1	Comply with 589.2001	Failure to comply with all applicable requirements in the regulations regarding cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy (BSE). Specifically,***

Biologics

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Biologics	76	21 CFR 606.100(b)	145	Maintained and followed	Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises]. Specifically, ***
	98	21 CFR 606.100(c)	56	Thorough investigations	Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications]. Specifically,***
	9225	21 CFR 606.171	38	Biological product deviation report	Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred]. Specifically, ***
	154	21 CFR 606.160(a)(1)	24	Concurrent documentation	Records are not concurrently maintained with the performance of each significant step in the [collection] [processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components so that all steps can be clearly traced. Specifically, ***
	160	21 CFR 606.160(a)(1)	21	Person performing, test results, interpretation	Records fail to [identify the person performing the work] [include dates of the various entries] [show test results] [include interpretation of the results] [show the expiration date assigned to specific products] [be as detailed as necessary] so as to provide a complete history of the work performed. Specifically, ***
	4425	21 CFR 606.60(a)	20	Equipment observed, standardized, calibrated	Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as prescribed in the SOP Manual. Specifically, ***
	67	21 CFR 606.65(e)	19	Following manufacturer's instructions	Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, ***
	15030	21 CFR 606.60(b)	18	Equipment calibration frequency	Equipment used in the [collection][processing][compatibility testing][storage and distribution] of blood and blood components is not observed, standardized and calibrated with at least the frequency required. Specifically, ***
	155	21 CFR 606.160(b)	17	Required records	Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***
	31	21 CFR 606.20(b)	16	Qualifications of responsible personnel	The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components are not adequate in [number] [educational background] [training and experience, including professional training as necessary]to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess. Specifically, ***
	94	21 CFR 606.100(b)(15)	13	Schedules and procedures for equipment & calibration	The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration. Specifically, ***
	9044	21 CFR 600.10(b)	13	Personnel capabilities	Failure to assure that personnel have [capabilities commensurate with] [the necessary training in] [necessary experience in] [a thorough understanding of] the operations which they perform. Specifically, ***
	159	21 CFR 606.160(a)(1)	11	Legibility and indelibility	Records are [illegible] [not indelible]. Specifically, ***
	78	21 CFR 606.100(c)	10	Record review prior to release	All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product. Specifically, ***
	208	21 CFR 640.3(a)(1)	9	Donor suitability procedures not followed	Failure to [follow] [maintain] [maintain on the premises] standard procedures and methods for determining the suitability of a donor as a source of blood. Specifically, ***
	12203	21 CFR 606.170(a)	8	Adverse Reaction- Reports of Investigations	Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically,
	89	21 CFR 606.100(b)(10)	7	Controlling storage temperatures	The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagentsSpecifically, ***
	93	21 CFR 606.100(b)(14)	7	QC procedures for supplies and reagents	The standard operating procedure fails to include a written description of the quality control procedures for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing]. Specifically, ***
	9243	21 CFR 630.6(a)	7	Notification	Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on suitability criteria]. Specifically, ***
	12202	21 CFR 606.170(a)	7	Adverse Reaction - Investigations	A thorough investigation of each reported adverse reaction was not made. Specifically,
	41	21 CFR 606.40(a)(1)	5	Provide space for examination	Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors. Specifically, ***
	57	21 CFR 606.60(a)	5	Maintain and clean equipment	Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood products [in a clean and orderly manner] [so as to facilitate cleaning and maintenance]. Specifically, ***
	251	21 CFR 640.25(b)	5	Quality control	Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for [platelet count] [pH of not less than 6.0 measured at the storage temperature of the unit] [actual plasma volume]. Specifically, ***
	9089	21 CFR 600.14(c)	5	When to report	Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***
	9220	21 CFR 606.100(b)(20)	5	Donor notification	The standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial attempt at donor notification fails]. Specifically, ***
	77	21 CFR 606.100(b)	4	Written SOPs available for use by personnel	Failure to make available written procedures for use by personnel in the areas where the procedures are performed. Specifically, ***
	80	21 CFR 606.100(b)(1)	4	Donor criteria	The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria. Specifically, ***
	117	21 CFR 606.121(f)	4	Labeling of blood products unsuitable for transfusion	Failure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with ["NOT FOR TRANSFUSION"] [the reason the unit is considered unsuitable]. Specifically, ***
	150	21 CFR 606.151(e)	4	Procedures to maintain records of emergency transfusions	Records [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including complete documentation justifying the emergency action]. Specifically, ***
	161	21 CFR 606.160(a)(2)	4	Determination of lot numbers and supplies	Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product. Specifically, ***
	165	21 CFR 606.170(a)	4	Adverse reaction - Maintenance of Reports	Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of [blood collection] [transfusion]. Specifically, ***
	224	21 CFR 640.4(f)	4	Arm preparation	The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, ***
	9235	21 CFR 630.6(c)	4	Documentation	Failure to [document that you have successfully notified a deferred donor] [document that you have made reasonable attempts to notify a deferred donor]. Specifically, ***
	215	21 CFR 640.3(b)(6)	3	Qualifications of donor - disease transmissible by blood	Failure to determine whether each donor is free from any disease transmissible by blood as determined by history and examinations. Specifically, ***
	218	21 CFR 640.3(c)(2)	3	History of viral hepatitis - close contact	An individual was used as a source of Blood who had a history of close contact within twelve months of donation with an individual having viral hepatitis. Specifically, ***
	227	21 CFR 640.4(h)	3	Storage temperatures after collection	After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius] [transported from the donor clinic to the processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius]. Specifically, ***
	246	21 CFR 640.25(a)	3	Storage temps./agitation	Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius]. Specifically, ***
	3248	21 CFR 640.63(a)	3	Determining donor suitability	Failure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision]. Specifically, ***
	3443	21 CFR 610.47	3	Notification of transfusion recipients	Failure to [notify the attending physician of a recipient of a lookback unit] [make a minimum of three attempts within 8 weeks to notify the recipient of a lookback unit in the event the physician does not inform the recipient] [notify recipient's legal representative or relative] [document notifications of lookback units]. Specifically, ***
	9086	21 CFR 600.14(a)(1)	3	Who must report - manufacturer	Failure to submit [a] biological deviation [report] [reports]. Specifically, ***
	9236	21 CFR 630.6(b)(1)	3	Deferred or not suitable	Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral]. Specifically, ***
	9256	21 CFR 610.41	3	Donor Deferral	Failure to defer a donor who tested reactive [by a screening test for evidence of infection due to a communicable disease agent] [for a serological test for syphilis] from further donations of human blood and blood components. Specifically, ***
	32	21 CFR 606.20(c)	2	Exclusion of certain persons	Failure to exclude persons whose presence can adversely affect the safety and purity of the products from areas where the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components is conducted. Specifically, ***
	35	21 CFR 606.40	2	Clean & orderly	Failure to maintain facilities in a clean and orderly manner. Specifically, ***
	61	21 CFR 606.60(a)	2	Provide proper equipment to meet requirements	Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606. Specifically, ***
	81	21 CFR 606.100(b)(2)	2	Donor qualifying tests & measurements	The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining acceptability. Specifically, ***
	91	21 CFR 606.100(b)(12)	2	Criteria for suitability of reissue of returned blood	The standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for reissue. Specifically, ***
	92	21 CFR 606.100(b)(13)	2	Procedures to relate blood from donor to final disposition	The standard operating procedure fails to include a written description of the procedures used for relating a unit of blood or blood component from the donor to its final disposition. Specifically, ***
	95	21 CFR 606.100(b)(16)	2	Labeling procedures to avoid labeling mix-ups	The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups]. Specifically, ***
	143	21 CFR 606.140(b)	2	Provisions to monitor lab test procedures & instruments	Failure to establishadequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments. Specifically, ***
	157	21 CFR 606.160(d)	2	Retention period	Failure to retain records [for 5 years after therecords of processing have been completed] [for 6 months after the latest expiration date for the individual product] [indefinitely where there is no expiration date]. Specifically, ***
	158	21 CFR 606.160(e)	2	Unsuitable donors	A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed. Specifically, ***
	205	21 CFR 640.3(f)	2	Donations in less than eight weeks	A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b). Specifically, ***
	253	21 CFR 640.25(b)(4)	2	Corrective action	Failure to [take immediate corrective action] [maintain a record of corrective action] when the quality control testing for platelets does not meet the prescribed requirements. Specifically, ***
	255	21 CFR 640.31	2	Donor suitability	Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
	376	21 CFR 640.120	2	Alternative procedures	Failure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components] [blood products]. Specifically, ***
	3245	21 CFR 640.61	2	Explanation of hazards	Failure to explain to the prospective Source Plasma donor [by a qualified physician] the [hazards of the plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor is hyperimmunized]. Specifically, ***
	9076	21 CFR 600.12(a)	2	Maintenance- concurrence	Records are not made [concurrently with the performance] of each step in the [manufacture] [distribution] of products. Specifically, ***
	9219	21 CFR 606.100(b)(20)	2	Donor deferral	The standard operating procedure fails to include a written description of the donor deferral process. Specifically, ***
	9240	21 CFR 630.6(d)(1)	2	Physician notification	Failure to provide to an autologous donor's referring physician [information that the autologous donor is deferred based on the results of tests for evidence of infection due to communicable disease agents, and the reason for that decision] [the types of donation of blood and blood components that the autologous donor should not donate in the future] [the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral] [results of any supplemental tests]. Specifically, ***
	9241	21 CFR 630.6(a)	2	Supplemental results	Failure to [attempt to obtain the results of supplemental testing prior to notifying a donor of a deferral] [notify a donor of the results of supplemental testing]. Specifically, ***
	9288	21 CFR 640.21	2	Suitability of donor	All [plasmapheresis] [plateletpheresis] donors did not meet the criteria for suitability. Specifically, **
	36	21 CFR 606.40	1	Suitable size, construction, etc.	Failure to provide facilities ofsuitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper operations. Specifically, ***
	38	21 CFR 606.40(b)	1	Adequate lighting, ventilation, and screening	Failure to provide adequate [lighting] [ventilation] [screening of open windows and doors]. Specifically, ***
42	21 CFR 606.40(a)(2)	1	Provide space for blood withdrawal	Failure to provide adequate space for the withdrawal of blood from donors with minimal [risk of contamination] [exposure to activities and equipment unrelated to blood collection]. Specifically, ***
43	21 CFR 606.40(a)(3)	1	Provide space for storage of blood & blood products	Failure to provide adequate space for the storage of blood or blood components pending completion of tests. Specifically, ***
54	21 CFR 606.40(d)(2)	1	Provide adequate disposal of blood & blood components	Failure to provide for safe and sanitary disposal for blood and blood components not suitable for use or distribution. Specifically, ***
63	21 CFR 606.65	1	Safe, sanitary, orderly storage	Failure to store all supplies and reagents used in the [collection][processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner. Specifically, ***
75	21 CFR 606.100(a)	1	SOP compliance	Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically, ***
82	21 CFR 606.100(b)(3)	1	Preparation of phlebotomy site	The standard operating procedure fails to include written descriptions of solutions and methods used to prepare the site of phlebotomy to give maximum assurance of a sterile container of blood. Specifically, ***
88	21 CFR 606.100(b)(9)	1	Written methods for investigating adverse reactions	The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions. Specifically, ***
108	21 CFR 606.120(c)	1	Legibility of labels	Failure to utilize clear and legible labeling. Specifically, ***
114	21 CFR 606.121(c)(1)	1	Proper name of product	The container label fails to include the [proper name] [modifier(s)] of the product in a prominent position. Specifically, ***
119	21 CFR 606.121(h)	1	Labeling requirements for emergency shipment	Failure to include [the statement, “FOR EMERGENCY USE ONLY BY __________”] [results of any tests prescribed under the regulations and completed] [tests prescribed under the regulations and not completed] on blood or blood components shipped in an emergency prior to completion of required tests. Specifically, ***
142	21 CFR 606.140(a)	1	Establishment of spec., standards, and test procedures	Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective. Specifically, ***
163	21 CFR 606.165(b)	1	Distribution records - content	Distribution records fail to contain information to readily facilitate identification of[the name and address of the consignee] [the date and quantity delivered] [the lot number of the unit(s)] [the date of expiration or date of collection] [the name of the recipient for crossmatched blood and blood components]. Specifically, ***
167	21 CFR 606.170(b)	1	Adverse reaction - fatality	A confirmed, fatal complication of [blood collection] [transfusion]was not [reported as soon as possible] [submitted in writing within 7 days after the fatality] to the Director, Office of Compliance, Center for Biologics Evaluation and Research by the [collecting facility in the event of a donor reaction] [facility that performed the compatibility tests in the event of a transfusion reaction]. Specifically, ***
206	21 CFR 640.3(a)	1	Donor suitability determined by unqualified person	Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a person under his supervision and trained in determining suitability. Specifically, ***
207	21 CFR 640.3(a)	1	Donor suitability not performed on day of collection	Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection. Specifically, ***
236	21 CFR 640.5(e)	1	Testing - inspection	Failure to [visually inspect blood during storage and immediately prior to issue for] [prevent issuance of blood found to have] abnormal color, physical appearance, or indication or suspicion of microbial contamination. Specifically, ***
238	21 CFR 640.11(a)	1	General requirements - storage	Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, ***
272	21 CFR 640.34(b)	1	Fresh Frozen Plasma - storage requirements	Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma, in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder. Specifically, ***
291	21 CFR 640.56(d)	1	Potency level - corrective action	Failure to [take immediate corrective action] [maintain records of corrective action] when the average potency level of antihemophilic factor in the containers is less than 80 units. Specifically, ***
300	21 CFR 640.67	1	Laboratory tests	Failure to test each unit of Source Plasma for evidence of infectious due to communicable disease agents. Specifically, ***
333	21 CFR 640.64(e)	1	Prevention of contamination	The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, ***
335	21 CFR 640.65(b)(1)(i)	1	Serological test	Failure to draw from each donor [on the day of the first medical exam or plasmapheresis] [at least every 4 months] a sample of blood tested for [syphilis] [total plasma or serum protein determination] [serum protein electrophoresis or equivalent test]. Specifically, ***
338	21 CFR 640.65(b)(2)(i)	1	Physician review of four month sample	Failure of the physician or physician substitute to [review] [sign] the [plasma or serum protein electrophoresis data] [collection records] within 21 days after the sample was drawn. Specifically, ***
3244	21 CFR 640.61	1	Written consent	Failure to obtain written consent of prospective Source Plasma donors. Specifically, ***
3252	21 CFR 640.63(a)	1	Determination not made on day of collection	Determination of the suitability of Source Plasma donors was not made on the day of collection. Specifically, ***
3254	21 CFR 640.63(b)(3)	1	Certification of good health	Failure of the examining physician to certify [on an appropriate form] that each donor is in good health and suitable for [plasmapheresis] [immunization]. Specifically, ***
3258	21 CFR 640.63(d)	1	Unreliable answers	Failure to consider as unsuitable any donor who does not appear to be providing reliable answers to medical history questions. Specifically, ***
3441	21 CFR 610.46(b)	1	Further testing and notification of results	As part of lookback procedures when a donor had tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise had been determined to be unsuitable when tested in accordance with the regulations, you failed to [perform] [notify consignees of the results of] a licensed, more specific test for HIV on the donor's blood within 30 days after the repeatedly reactive test. Specifically, ***
3452	21 CFR 601.12(b)	1	Major changes to an approved application	Failure to [submit a supplement] [receive supplement approval from FDA] prior to distributing product made using the change. Specifically, ***
3543	21 CFR 610.46(a)(1)	1	Quarantine and notification	When a donor tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise was determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action within 72 hours to [institute a quarantine] [notify your consignee(s) for the purpose of instituting a quarantine] of [whole blood] [blood components] [source plasma] [source leukocytes] collected from the donor. Specifically, ***
9078	21 CFR 600.12(a)	1	Maintenance- tracing	Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced. Specifically, ***
9087	21 CFR 600.14(a)(1)	1	Who must report - receiving information	Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed biological product subject to biological product deviation reporting. Specifically, ***
9097	21 CFR 600.15	1	Blood & Blood Components	Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 °C or colder] [Cryoprecipitated AHF at -18 °C or colder] [Liquid Plasma at 1 to 10 °C] [Plasma at -18 °C or colder] [Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the labeled range] [Red Blood Cells between 1 and 10 °C] [Red Blood Cells, Frozen at -65 °C or colder] [Source Plasma at -5 °C or colder] [Source Plasma Liquid at 10 °C or colder] [Whole Blood as required]. Specifically, ***
9223	21 CFR 606.160(b)(6)	1	Required records - transfusion reaction and complaints	Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up. Specifically, ***
9234	21 CFR 630.6(c)	1	Notification w/in 8 weeks	Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation. Specifically, ***
9262	21 CFR 610.40(b)	1	Approved screening tests	Blood or blood components were not tested for evidence of infection due to communicable disease agents [using screening tests that the FDA has approved for such use][in accordance with the manufacturer's instructions]. Specifically, ***
9264	21 CFR 610.40(d)(4)	1	Autologous donation - label	Failure to label autologous donations with the [name of the donor] [identifying information of the donor] [appropriate caution statement]. Specifically, ***
9269	21 CFR 610.40(h)	1	Shipment/use of reactive units, units from deferred donors	Human blood or blood components that were [reactive by a screening test] [collected from a donor with a previous record of a reactive screening test] for evidence of a communicable disease agent were [shipped] [used] without meeting the exceptions set forth at 21 CFR 610.40(h)(2). Specifically, ***
9297	21 CFR 640.52	1	Collection	Failure to ensure that source material is collected using appropriate methods. Specifically, ***
9314	21 CFR 640.65(b)(2)(i)	1	Physician review of results	Failure to have the accumulated laboratory data reviewed by a qualified licensed physician within 21 days after the sample was drawn to determine whether or not the donor may continue in the program. Specifically, ***
9315	21 CFR 640.65(b)(3)	1	Donor identification	Failure to establish a system that positively identifies each donor and relates such donor directly to his [blood] [accumulated records and laboratory data]. Specifically, ***
9560	21 CFR 660.32	1	Same as for whole blood	Blood for reagent red blood cells is not collected from peripheral donors as prescribed under applicable sections of the regulation for the collection of whole blood. Specifically, ***

Parts 1240 and 1250

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Parts 1240 and 1250	7036	21 CFR 1250.67	49	Prevention of contamination	Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps] [faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking] [culinary] water. Specifically, ***
	6560	21 CFR 1250.32(a)	33	Contamination	Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***
	7053	21 CFR 1250.75(b)	26	Sanitary sewers or alternative methods	Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***
	7032	21 CFR 1250.63	22	Prevention of the spread of communicable diseases	Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable diseases. Specifically, ***
	6558	21 CFR 1250.30(d)	21	Plumbing design, installation, maintenance	Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***
	6579	21 CFR 1250.38(a)	18	Suitable design and construction	Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***
	6570	21 CFR 1250.33(c)	16	Storage and handling after bactericidal treatment	Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse. Specifically, ***
	6564	21 CFR 1250.33(a)	14	Maintained in good repair	Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair. Specifically, ***
	6569	21 CFR 1250.33(b)	12	Equipment kept clean	Failure to keep all equipment clean. Specifically, ***
	6581	21 CFR 1250.38(b)	11	Soap, sanitary towels, water	Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, ***
	6593	21 CFR 1250.42(b)	9	Connections easily cleanable, located and protected	Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply. Specifically, ***
	6552	21 CFR 1250.28	7	Handling to avoid contamination	Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination. Specifically, ***
	6554	21 CFR 1250.30(a)	7	Ventilation and lighting	Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, ***
	6555	21 CFR 1250.30(a)	7	Clean and free from flies, rodents, and other vermin	Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin]. Specifically, ***
	6549	21 CFR 1250.27	6	Storage of perishables	Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving. Specifically, ***
	6572	21 CFR 1250.34	6	Thermometers	Failure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, ***
	6591	21 CFR 1250.42(a)	6	Backflow protection	A water system not protected against backflow. Specifically, ***
	6585	21 CFR 1250.39	5	Containers - close-fitting covers	Garbage containers lack close-fitting covers. Specifically, ***
	7051	21 CFR 1250.75(a)	5	Contamination of passenger stations	Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, ***
	6565	21 CFR 1250.33(a)	4	Adequate facilities for cleaning, bactericidal treatment	Adequate facilities are not provided for the [cleaning] [bactericidal treatment] of [multiuse eating and drinking utensils] [equipment used in the preparation of food and beverages]. Specifically, ***
	7030	21 CFR 1250.62	4	Submittal of construction plans	Failure to submit plans for the [construction] [major reconstruction] of sanitation facilities at servicing areas to FDA for review. Specifically, ***
	7041	21 CFR 1250.70(a)	4	Adequate and readily accessible	Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained] [cleaned]. Specifically, ***
	6561	21 CFR 1250.32(b)	3	Clean hands	Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, ***
	6567	21 CFR 1250.33(b)	3	Cleaning of multiuse eating and drinking utensils	Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse eating and drinking utensils after each use. Specifically, ***
	6580	21 CFR 1250.38(b)	3	Signs	Signs directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such employees]. Specifically, ***
	6584	21 CFR 1250.39	3	Containers - watertight, readily cleanable, non-absorbent	Garbage containers are not [watertight] [readily cleanable] [non-absorbent]. Specifically, ***
	6566	21 CFR 1250.33(a)	2	Indicating thermometer for hot water	Hot water is used as the bactericidal agent for [multiuse eating and drinking utensils] [equipment used in the preparation of food and beverages], but no [adequate] indicating thermometer [suitably located] is provided to determine the hot water temperature. Specifically, ***
	7037	21 CFR 1250.67	2	Outlets for non-potable water	Outlets for non-potable water have not been provided with fittings different from those provided for outlets for potable water. Specifically, ***
	7118	21 CFR 1250.90	2	Clean condition	Toilet and lavatory [equipment] [spaces] not maintained in a clean condition. Specifically, ***
	6508	21 CFR 1240.61(a)	1	Not pasteurized	Milk or milk product in final package form for direct human consumption has not been pasteurized or made from dairy ingredients that have all been pasteurized. Specifically, ***
	6515	21 CFR 1240.65	1	Lack of permit	Psittacine birds are being [transported] [offered for transportation] in interstate commerce without the shipment being accompanied by a required permit from the State health department of the State of destination. Specifically, ***
	6531	21 CFR 1250.22	1	Clean, wholesome, free from spoilage	Not all [food] [drink] served onboard is [clean] [wholesome] [free from spoilage]. Specifically, ***
	6557	21 CFR 1250.30(c)	1	Water supply	Water [of satisfactory sanitary quality] [under head of pressure] [adequate in amount and temperature] is not easily accessible to all rooms in which [food is prepared] [utensils are cleaned]. Specifically, ***
	6563	21 CFR 1250.33(a)	1	Easily cleaned, self-draining	Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are constructed so as to be [easily cleaned] [self-draining]. Specifically, ***
	6582	21 CFR 1250.38(c)	1	Maintained in clean condition	Failure to maintain toilet rooms in a clean condition. Specifically, ***
	6588	21 CFR 1250.41	1	Submittal of construction plans	Failure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review. Specifically, ***
	6590	21 CFR 1250.42(a)	1	Complete and closed	A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically, ***
	7034	21 CFR 1250.65	1	Pooling	Drainage at places where water or food supplies are loaded into or removed from conveyances is inadequate to prevent pooling. Specifically, ***
	7039	21 CFR 1250.67	1	Bulk ice	Equipment used to [store] [wash] [handle] [deliver] bulk ice intended for [the cooling of drinking water or other beverages] [food preservation purposes] is not [constructed so as not to become a factor in the transmission of communicable diseases] [used for no other purposes]. Specifically, ***
	7054	21 CFR 1250.75(b)	1	Soil cans and removable containers	Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use. Specifically, ***
	7055	21 CFR 1250.75(b)	1	Equipment for cleaning and flushing	Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and waste carts] is [not designed so as to prevent backflow into the water line] [used for a purpose connected with the handling of food, water, or ice]. Specifically, ***
	7060	21 CFR 1250.79(c)	1	Daily emptying and cleaning	Garbage cans are not [emptied daily] [thoroughly washed before being returned for use]. Specifically, ***
	7090	21 CFR 1250.82(e)	1	Backflow prevention - general	Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, ***
	7092	21 CFR 1250.82(f)	1	Cleaning, disinfecting, flushing	Failure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases. Specifically, ***
	7112	21 CFR 1250.87	1	Labeling of faucets	Systems for wash water do not meet the requirements of a potable water system, and not all faucets are labeled "Unfit for drinking."Specifically, ***
	7120	21 CFR 1250.95	1	Infestation by flies, mosquitoes, fleas, lice, other insects	Failure to prevent, through generally accepted methods of control, an infestation by [flies] [mosquitoes] [fleas] [lice] [insects known to be vectors in the transmission of communicable diseases]. Specifically, ***

Human Tissue for Transplantation

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Human tissue for transplantation	12221	21 CFR 1271.47(a)	30	Procedures for all steps	Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12336	21 CFR 1271.180(a)	17	Procedures to meet core CTGP	Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12229	21 CFR 1271.50(a)	13	Determination based on screening and testing	HCT/P donors were not determined to be eligible based on the results of donor screening and testing. Specifically, ***
	12277	21 CFR 1271.75(a)(1)	11	Risk factors, clinical evidence	Donors were not screened by a review of relevant medical records for [risk factors][clinical evidence] of communicable disease agents and diseases. Specifically, ***
	12230	21 CFR 1271.50(a)	10	Responsible person to determine, document	The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on results of donor screening and donor testing. Specifically, ***
	12247	21 CFR 1271.55(d)(2)	10	Accurate, indelible, legible	Donor eligibility records are not [accurate] [indelible] [legible]. Specifically, ***
	12282	21 CFR 1271.75(d)	9	Donors with risks not determined ineligible	Donors were not determined to be ineligible that had [risk factors or clinical evidence of communicable disease agents] [communicable disease risks associated with xenotransplantation]. Specifically, ***
	12310	21 CFR 1271.160(a)	9	All core requirements covered in program	A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12457	21 CFR 1271.320(a)	8	Procedures re complaints	Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12492	21 CFR 1271.85(a)	8	Infection with communicable disease agents	Donors were not tested for evidence of infection with communicable disease agents. Specifically, ***
	12213	21 CFR 1271.47(a)	7	Donor eligibility procedures	Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12416	21 CFR 1271.260(e)	7	Storage temperatures recorded, maintained	Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
	12437	21 CFR 1271.270(a)	7	Records incomplete	Records [did not identify the person performing the work] [did not show the dates of entries] [were not detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P involved]. Specifically, ***
	12223	21 CFR 1271.47(b)	6	Review and approval of procedures	Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
	12399	21 CFR 1271.230(a)	6	Process validation procedures	Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12222	21 CFR 1271.47(a)	5	Design of procedures to ensure compliance	Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically, ***
	12369	21 CFR 1271.200(b)	5	Procedures inadequate	Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
	12433	21 CFR 1271.265(f)	5	Return to inventory--procedures	Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned to inventory were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12489	21 CFR 1271.90(b)(1)	5	Autologous use only--labeling	HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only. Specifically, ***
	15020	21 CFR 1271.200(e)	5	Documentation of maintenance and cleaning	Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained. Specifically, ***
	12225	21 CFR 1271.47(d)	4	Departures: recording and justifying	Departures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified]. Specifically, ***
	12238	21 CFR 1271.55(b)(1)	4	Statement re: certified testing lab	The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services. Specifically, ***
	12288	21 CFR 1271.80(c)	4	Manufacturer instructions not followed	Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions. Specifically, ***
	12290	21 CFR 1271.80(d)(1)	4	Reactive tests--not determined ineligible	Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible. Specifically, ***
	12325	21 CFR 1271.160(b)(6)	4	Deviations--evaluation, cause, corrective action	Investigation of deviations related to coreCGTP requirements did not include [a review and evaluation of the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the deviation and prevent recurrence]. Specifically, ***
	12371	21 CFR 1271.200(a)	4	Cleaned, sanitized per established schedules	Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]according to established schedules. Specifically, ***
	12435	21 CFR 1271.270(a)	4	Records maintained concurrently	Records were not maintained concurrently with the performance of each step. Specifically, ***
	12453	21 CFR 1271.290(e)	4	Documenting disposition of each HCT/P	A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if any]. Specifically, ***
	12246	21 CFR 1271.55(d)(1)(iii)	3	Documentation--determination, by whom, date	Documentation of [the donor-eligibility determination] [the responsible person who made the donor-eligibility determination] [the date of the donor-eligibility determination] was not maintained. Specifically, ***
	12283	21 CFR 1271.75(e)	3	Abbreviated procedure	The abbreviated donor screening procedure [was used for donors who had no complete donor screening procedure in the previous six months] [did not determine and document changes in the donor's medical history that would make the donor ineligible]. Specifically, ***
	12311	21 CFR 1271.160(b)(1)	3	Ensuring appropriate core requirements followed	The quality program has not ensured that appropriate procedures related to core CGTP requirements were[established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [approved] [revised]. Specifically, ***
	12326	21 CFR 1271.160(c)	3	Quality audits performed periodically	Periodic quality audits of activities related to core CGTP requirements have not been performed. Specifically, ***
	12351	21 CFR 1271.190(d)(1)	3	Procedures for cleaning, sanitation	Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
	12354	21 CFR 1271.190(d)(2)	3	Documentation of activities	Documentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
	12365	21 CFR 1271.195(d)	3	Documentation not maintained	Documentation of environmental control and monitoring activities was not maintained. Specifically, ***
	12370	21 CFR 1271,200(c)	3	Calibration procedures and schedules (general)	The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing] were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12381	21 CFR 1271.210(d)(2)	3	Verification elements	Documentation of the verification of [supplies] [reagents] did not include [test results] [a certificate of analysis from the vendor]. Specifically, ***
	12438	21 CFR 1271.270(b)	3	Management system re: core CGTPs	A records management system relating to core CGTP requirements was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12231	21 CFR 1271.50(b)(1)	2	Donor screening standards	Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk factors for infection due to communicable disease agents] [clinical evidence of infection due to communicable disease agents] [risk factors associated with xenotransplantation]. Specifically, ***
	12232	21 CFR 1271.50(b)(2)	2	Donor testing not negative for CD agents	Donor testing of HCT/P donors considered eligible was not negativeor nonreactive for relevant communicable disease agents. Specifically, ***
	12236	21 CFR 1271.55(a)(2)	2	Eligibility statement--basis of determination	After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing. Specifically, ***
	12237	21 CFR 1271.55(a)(3)	2	Summary--records used to make determination	After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination. Specifically, ***
	12239	21 CFR 1271.55(b)(2)	2	Listing and interpretation of CD tests performed	The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed. Specifically, ***
	12240	21 CFR 1271.55(b)(3)	2	Name and address on summary	The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination. Specifically, ***
	12242	21 CFR 1271.55(c)	2	Name and personal info on accompanying records	The accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor]. Specifically, ***
	12252	21 CFR 1271.60(a)	2	Completion of eligibility determination	HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination. Specifically, ***
	12257	21 CFR 1271.60(c)(2)	2	Records stating determination not completed	HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the donor-eligibility determination had not been completed. Specifically, ***
	12287	21 CFR 1271.80(c)	2	Kits not FDA approved, specifically labeled	Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests] [were not specifically labeled for cadaveric specimens when such a test was available and cadaveric specimens were used]. Specifically, ***
	12301	21 CFR 1271.150(c)(1)(iii)	2	Ensurane of compliance	You did not ensure that establishment(s) thatby contract, agreement or arrangement, perform manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the initiation of the contract, agreement of arrangement] [applicable CGTP requirements after information became available that suggested the establishment was no longer in compliance]. Specifically, ***
	12322	21 CFR 1271.160(b)(4)	2	Training of personnel	The quality program has not ensured the proper training and education of personnel involved in core GTP activities. Specifically, ***
	12332	21 CFR 1271.170(b)	2	Qualifications lacking	Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions. Specifically, ***
	12387	21 CFR 1271.220(a)	2	Causing contamination, increasing risks	HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during processing] [that does not increase the risk of introduction, transmission, or spread of communicable disease]. Specifically, ***
	12405	21 CFR 1271.250(a)	2	Controlling the labeling of HCT/Ps	Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
	12411	21 CFR 1271.260(a)	2	Contamination, mix ups, improper release	Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made available for distribution]. Specifically, ***
	12421	21 CFR 1271.265(a)	2	Acceptance criteria designed to prevent CD	Incoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria designed to prevent communicable disease transmission. Specifically, ***
	12425	21 CFR 1271.265(c)(1)	2	Release of HCT/Ps by responsible person	Aresponsible person did not [document] [date] the determination that an HCT/P is available for distribution. Specifically, ***
	12432	21 CFR 1271.265(e)	2	Documentation elements for activities	Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include [identification of the HCT/P and the establishment that supplied the HCT/P] [activities performed and the results of each activity] [date(s) of activity] [quantity of HCT/P subject to the activity] [disposition of the HCT/P (identity of consignee)]. Specifically, ***
	12436	21 CFR 1271.270(a)	2	Accurate, indelible, legible	Records were not [accurate] [indelible] [legible]. Specifically, ***
	12443	21 CFR 1271.270(d)	2	Retention time (10 year rules)	Records were not retained for the appropriate length of time,[10 years after their creation] [at least 10 years after the date of administration of a particular HCT/P] [at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of administration is not known] [10 years after the appropriate disposition of archived specimens of dura mater]. Specifically, ***
	12493	21 CFR 1271.90(b)	2	Eligibility not required--warning labels	HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements. Specifically, ***
	12494	21 CFR 1271.85(c)	2	Reproductive cells or tissues	Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for communicable diseases of the genitourinary tract. Specifically, ***
	12496	21 CFR 1271.85(b)(2)	2	SOP for release; reactive for CMV	A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically. ***
	15019	21 CFR 1271.160(d)	2	Computer software verification	The performance of computer software has not been verified. Specifically, ***
	15025	21 CFR 1271.85(b)(2)	2	Cytomegalovirus (CMV)	Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to cytomegalovirus (CMV). Specifically, ***
12241	21 CFR 1271.55(b)(4)	1	Reasons for ineligibility on summary	The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for theineligibility. Specifically, ***
12243	21 CFR 1271.55(d)(1)	1	Documentation maintained (general)	Documentation was not maintained after the donor-eligibility determination was complete. Specifically, ***
12244	21 CFR 1271.55(d)(1)(i)	1	Documentation of CD testing and labs	Documentation of [the results and interpretation of all relevant testing for communicable disease agents][the name and address of the communicable disease testing laboratory or laboratories] was not maintained. Specifically, ***
12245	21 CFR 1271.55(d)(1)(ii)	1	Results, interpretation of CD screening	Documentation of [the results] [the interpretation] of all donor screening for communicable diseases was not maintained. Specifically, *
12248	21 CFR 1271.55(d)(2)	1	Information, English or translated-authenticity	Information on [the identity] [the relevant medical records] of donors of HCT/Ps were [not in English] [not retained and translated to English] [not accompanied by a statement of authenticity by the translator that specifically identifies the translated document]. Specifically, ***
12250	21 CFR 1271.55(d)(4)	1	Ten year retention	Records pertaining to HCT/Ps were not retained [at least 10 years after the date of administration] [at least 10 years after the date of distribution, disposition, or expiration, whichever was latest when the date of administration of the HCT/P was unknown]. Specifically, ***
12255	21 CFR 1271.60(c)	1	Shipped but not kept in quarantine	HCT/Ps shipped prior to the completion of the donor-eligibility determination were not kept in quarantine during shipment. Specifically, ***
12270	21 CFR 1271.65(a)	1	Improper release prevention--storage, I.D.	HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release. Specifically, ***
12272	21 CFR 1271.65(b)(2)	1	Labeled re: biohazard, risks, test results	HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning of the reactive test results]. Specifically, ***
12279	21 CFR 1271.75(b)	1	Risk factors, leukocyte-rich cells or tissues	Donors of leukocyte-rich cells or tissues were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of cell-associated communicable disease agents and diseases. Specifically, ***
12281	21 CFR 1271.75(c)	1	Reproductive cells/tissues-Chlamydia, Neisseria	Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of [Chlamydia trachomatis] [Neisseria gonorrhea]. Specifically, ***
12320	21 CFR 1271.160(b)(3)	1	Actions verified, short and long term solutions	Corrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and compliance with CGTP] [did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence]. Specifically, ***
12321	21 CFR 1271.160(b)(3)	1	Problem description, disposition, date et. al.	Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the nature of the problem] [the description of the corrective action] [the date of the corrective action]. Specifically, ***
12323	21 CFR 1271.160(b)(5)	1	Monitoring systems	The quality program has not established and maintained appropriate monitoring systems. Specifically, ***
12334	21 CFR 1271.170(c)	1	Trained or re-trained as necessary	Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities. Specifically, ***
12337	21 CFR 1271.180(a)	1	Design adequate to bar spread of CD's	Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and spread through the use of HCT/Ps. Specifically, ***
12338	21 CFR 1271.180(b)	1	Review and approval-responsible person	Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
12340	21 CFR 1271.180(d)	1	Adopted from another organization	Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations]. Specifically, ***
12342	21 CFR 1271.190(a)	1	Size, construction, location--prevent mix-ups etc.	Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups]. Specifically, ***
12353	21 CFR 1271.190(d)(1)	1	Description of methods, schedule	Facility cleaning and sanitation procedures did not describe [the cleaning methods to be used] [the schedule for cleaning]. Specifically, ***
12361	21 CFR 1271.195(b)	1	Periodic inspection	Environmental control systems are not periodically inspected to verify adequate and proper function. Specifically, ***
12364	21 CFR 1271.195(c)	1	Monitoring-microorganisms where appropriate	Environmental conditions were not monitored for microorganisms. Specifically, ***
12372	21 CFR 1271.200(c)	1	Calibrated per established schedules	Equipment used for [inspection] [measuring] [testing] was not calibratedaccording to established schedules. Specifically, ***
12373	21 CFR 1271.200(d)	1	Inspected routinely	Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules]. Specifically, ***
12375	21 CFR 1271.210(a)	1	Use prior to verification	Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease. Specifically, ***
12378	21 CFR 1271.210(d)(1)	1	Receipt documentation maintained	Documentation of the receipt of [supplies] [reagents] was not maintained. Specifically, ***
12379	21 CFR 1271.210(d)(1)	1	Receipt documentation elements	The documentation for the receipt of [supplies] [reagents] did not include [the type] [the quantity] [the manufacturer] [the lot number] [the date of receipt] [the expiration date]. Specifically, ***
12382	21 CFR 1271.210(d)(3)	1	Lot documentation maintained	Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained. Specifically, ***
12385	21 CFR 1271.150(c)(2)	1	Responsibility for review before distribution	HCT/Ps were determined to meet all release criteria and made available for distribution without review of [manufacturing] [tracking] records to determine that all applicable requirements were met. Specifically, ***
12395	21 CFR 1271.225	1	Verification/validation	Process changes were not [validated] [verified]to ensure the change does not cause an adverse impact elsewhere in operations. Specifically, ***
12398	21 CFR 1271.230(a)	1	Validation & approval--established procedures	Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures. Specifically, ***
12402	21 CFR 1271.230(c)	1	Changes to validated process	A validated process that was changed was not [reviewed] [evaluated] [revalidated]. Specifically, **
12412	21 CFR 1271.260(b)	1	Storage temperatures appropriate	HCT/Ps were not stored at appropriate temperatures. Specifically, ***
12413	21 CFR 1271.260(c)	1	Expiration date factors	HCT/Ps were not assigned an expiration date based on [type of HCT/P] [processing, including method of preservation] [storage conditions] [packaging]. Specifically, ***
12417	21 CFR 1271.260(e)	1	Periodic review of temperatures	Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits. Specifically, ***
12419	21 CFR 1271.265(a)	1	Evaluation--microorganisms, damage	Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination]. Specifically, ***
12422	21 CFR 1271.265(b)	1	Shipment of HCT/Ps - pre-established criteria	HCT/Ps shipped as pre-distribution shipments [within your establishment] [between establishments] which do not meet the criteria for being available for distribution were not determined and documented to have met pre-established criteria designed to prevent communicable disease transmission. Specifically, ***
12424	21 CFR 1271.265(c)(1)	1	Release criteria verified, documented	Release criteria were not [verified] [documented] to have been met through a review of manufacturing and tracking records before HCT/Ps were made available for distribution. Specifically, ***
12429	21 CFR 1271.265(d)	1	Shipping conditions appropriate	Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, ***
12431	21 CFR 1271.265(e)	1	Procedures and release criteria	Procedures includingrelease criteria for activities relating tothe [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
12446	21 CFR 1271.290(a)	1	HCT/Ps not tracked	HCT/Ps are not tracked [to facilitate the investigation of transmission of communicable disease] [to take corrective actions]. Specifically, ***
12447	21 CFR 1271.290(b)	1	Establishing a system	A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
12458	21 CFR 1271.320(b)	1	Designated complaint file	Complaints received were not maintained in a file designated for complaints. Specifically, ***
12460	21 CFR 1271.320(c)	1	Review and evaluation, report to FDA	Complaints were not reviewed and evaluated to determine [if the complaint is related to an HCT/P deviation or adverse reaction] [whether a report to FDA is required]. Specifically, ***
12468	21 CFR 1271.350(a)(1)	1	Investigation of adverse reactions	Adverse reactions involving a communicable disease related to HCT/Ps were not investigated. Specifically, ***
12490	21 CFR 1271.85(b)(1)	1	Cell-associated CD	Donors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases. Specifically, ***
15026	21 CFR 1271.85(c)	1	Reproductive cells or tissues-cell-associated CD	Donors of viable, leukocyte-rich reproductive cells or tissues were not tested for cell-associated communicable diseases or cytomegalovirus (CMV). Specifically, ***

Radiological Health

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Radiological health	5007	21 CFR 1002.13	10	Failure to submit	You did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, ***
	5032	21 CFR 1010.2(b)	5	Certification label or tag	A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible] [readily accessible to view when the product is fully assembled for use]. Specifically, ***
	5044	21 CFR 1010.3(a)(2)	5	ID label lacks place, month & year of manufacture	An identification label fails to provide the [place] [month] [year] of manufacture. Specifically, ***
	5200	21 CFR 1040.10(h)(1)(iv)	5	User info - list controls, etc.	The manufacturer did not provide or cause to be provideda listing of [all controls] [all adjustments] [all procedures for operation and maintenance] [the warning: "Caution --- use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure."]. Specifically, ***
	5158	21 CFR 1040.10(f)(6)(i)	4	Beam attenuator	A laser system classified as a [Class II] [Class III] [Class IV] laser system was not provided with one or more permanently attached means, other than laser energysource switches, electrical supply main connectors, or the key-actuated master control, capable of preventing access by any part of the human body to all laser and collateral radiation in excess of the accessible emission limits of Class I and table VI. Specifically, ***
	5203	21 CFR 1040.10(h)(2)(i)	4	Reproduction of affixed information	The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets] [descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation] [the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to be affixed to the product. Specifically, ***
	5700	21 CFR 1002.10	4	Failure to submit, distinct marking	You did not submit a required product report [distinctly marked "Radiation Safety Product Report of (your name)"] prior to the introduction of the product into commerce. Specifically, ***
	5151	21 CFR 1040.10(f)(4)	3	Key control	Each laser system classified as a Class IIIb or Class IV] laser product [did not incorporate a[key-actuated master control] [did not have a removable key] [was operable when the key was removed.]Specifically, ***
	5205	21 CFR 1040.10(h)(2)(ii)	3	Precautions and protective procedures	Adequate instructions for service adjustments and service procedureswere not provided or caused to be provided for each laser model, including [clear warnings and precautions to be taken to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits specified in the CFR] [protective procedures for service personnel to avoid exposure to levels of laser and collateral radiation known to be hazardous for each procedure or sequence of procedures to be accomplished]. Specifically, ***
	5012	21 CFR 1003.10(a)	2	FDA not notified of defect or noncompliance	You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled] [imported] [distributed]. Specifically, ***
	5029	21 CFR 1005.25(a)	2	Failure to designate US agent for process service	A permanent resident of the United States was not designated as the manufacturer's agent prior to offering electronic products for importation. Specifically, ***
	5153	21 CFR 1040.10(f)(5)(ii)	2	Emission indicator - Class IIIb & IV	An emission indicator [was not incorporated in each laser system classified as a Class IIIb or Class IV laser product, which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I] [which signals sufficiently prior to emission of such radiation, to allow appropriate action to avoid exposure to the laser radiation]. Specifically, ***
	5170	21 CFR 1040.10(g)(2)(iii)	2	Class IIIb "Danger" label	Each Class IIIb laser product does not have affixed a label[bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID DIRECT EXPOSURE TO BEAM" in the position specified in the regulation] [bearing the wording "CLASS IIIb LASER PRODUCT" in the position specified in the regulation]. Specifically, ***
	5197	21 CFR 1040.10(h)(1)(i)	2	User information, adequate instructions	Adequate instructions for each laser product were not provided or caused to be provided for [assembly] [operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits specified in the regulations] [a maintenance schedulenecessaryto keep the product in compliance with the standard]. Specifically, ***
	5199	21 CFR 1040.10(h)(1)(iii)	2	Legible reproductions	Legible reproductions of all labels and hazard warnings required by the regulations [were not affixed to the laser product] [were not provided with the laser product] [did notinclude the information required for positions 1, 2, and 3 of the logotype specified in the CFR]. Specifically, ***
	5468	21 CFR 1020.30(j)	2	Mandatory warning on control panel	The required warning statement "Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed" [is not present on the control panel containing the main power switch] [is not legible and accessible to view]. Specifically, ***
	5802	21 CFR 1002.13	2	Lack of required elements	An annual report which you submitted did not [summarize the contents of the records required by 21 CFR 1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period ending on June 30 preceding the due date of the report]. Specifically, ***
	5005	21 CFR 1002.11	1	Failure to submit	You did not submit a required supplemental report, prior to the introduction of the product into commerce, for a new or modified model within a model or chassis family. Specifically, ***
	5008	21 CFR 1002.20(a)	1	Failure to report	You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you. Specifically, ***
	5013	21 CFR 1003.10(b)	1	Dealers, distributors, purchasers not notified	You did not notify [all of] the [dealers] [distributors] [purchasers] [subsequent transferees] of an electronic product which [was defective] [failed to comply with an applicable Federal standard] . Specifically, ***
	5019	21 CFR 1004.1	1	CAP not submitted	In a situation where an electronic product you have manufactured [fails to comply with an applicable Federal standard] [has a defect subject to the notification requirements of 21 CFR 1003.10(b)], you have not submitted a plan to the Secretary to [bring the product into conformity with the standard] [remedy the defect] without charge (including reimbursement of any transportation expenses), replace the product with a like or equivalent one which [complies with the standard] [is free of defects relating to safety of its use], or refund the cost of the product to the purchaser. Specifically, ***
	5034	21 CFR 1010.2(c)	1	Certification not based on adequate test/testing program	Certification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices]. Specifically, ***
	5043	21 CFR 1010.3(a)(1)	1	ID label lacks name and address	An identification label failed to provide the name and address of the [manufacturer] [individual or company under whose name the product was sold]. Specifically, ***
	5045	21 CFR 1010.3(a)(2)(i)	1	ID label manufacturing location code key not revealed to FDA	The key to the code for the place of manufacture, used on an identification label, has not been revealed to FDA. Specifically, ***
	5046	21 CFR 1010.3(a)(2)(ii)	1	Manufacture date abbreviated or unapproved date coding	The date of manufacture provided on the identification label is [not clear and legible] [abbreviated] [not stated in the prescribed manner]. Specifically, ***
	5141	21 CFR 1040.10(e)(1)	1	Certification tests inadequate	The tests on which certification is based failed to account for [all errors and statistical uncertainties in the measurement process][increases in emission and degradation in radiation safety with age]. Specifically, ***
	5143	21 CFR 1040.10(f)(1)	1	Protective housing	Each laser product is not provided with a protective housing that prevents human access during operations to laser and collateral radiation that exceeds the limits of Class I and table VI, respectively, wherever and whenever such human access is not necessary for the product to perform its intended function(s). Specifically, ***
	5146	21 CFR 1040.10(f)(2)(iii)(a)	1	No multiple safety interlock	A laser product was not provided with either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing, when failure of a single interlock allowed human access to a level of laser radiation in excess of the accessible emission limits of Class IIIa. Specifically, ***
	5150	21 CFR 1040.10(f)(3)	1	Remote interlock connector	Each laser system classified as a Class IIIb or Class IV laser product [was not incorporated with a readily available remote interlock connector having an electrical potential difference of no greater than 130 root-mean-square volts between terminals.] [had no means to prevent, when the terminals of the connector are not electrically joined, human access to all laser and collateral radiation from the laser product in excess of the accessible emission limits of Class I and table VI.]Specifically, ***
	5152	21 CFR 1040.10(f)(5)(i)	1	Emission indicator - Class II & IIIa	An emission indicator was not incorporated in each laser system classified as a Class II or Class IIIa laser product that provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I. Specifically, ***
	5167	21 CFR 1040.10(g)(1)(ii)	1	Class II "Caution" label	Each Class II laser product does not have affixed a label [bearing the wording "LASER RADIATION--DO NOT STARE INTO BEAM" in the position specified in the regulation] [bearing the wording CLASS II LASER PRODUCT" in the position specified in the regulation]. Specifically, ***
	5171	21 CFR 1040.10(g)(3)	1	Class IV "Danger" label	Each Class IV laser product does not have affixed a label[bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation]. Specifically, ***
	5173	21 CFR 1040.10(g)(5)(i)	1	Aperture label - laser radiation	The warning statement "AVOID EXPOSURE---Laser radiation is emitted from this aperture" was not affixed in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the accessible emission limits of Class I and table VI of Section 1040.10(d). Specifically, ***
	5174	21 CFR 1040.10(g)(5)(ii)	1	Aperture label wording - collateral EM radiation	The following label on the laser product was not affixed in close proximity to each aperture through which is emitted accessible collateral radiation in excess of the accessible emission limits of Class I and table VI of Section 1040.10(d): "AVOID EXPOSURE --- Hazardous electromagnetic radiation is emitted from this aperture". Specifically, ***
	5180	21 CFR 1040.10(g)(6)(iv)	1	NIPH label wording - Class IIIb	Labels regarding Class IIIb accessible laser radiation which [are visible on the protective housing prior to displacement or removal of such portions of the protective housing] [are visible on the product in close proximity to the opening created by removal or displacement of such portions of the protective housing] [include the wording: "DANGER --- Laser radiation when open.AVOID DIRECT EXPOSURE TO BEAM."] were not provided for noninterlocked protective housings. Specifically, ***
	5192	21 CFR 1040.10(g)(8)(i)	1	Label wording for invisible radiation	The word "radiation" was not preceded with the word "invisible" when the laser or collateral radiation referred to on the [warning label] [aperture label] [noninterlocked protective housing label] [defeatably interlocked protective housing label] invisible. Specifically, ***
	5217	21 CFR 1040.20(c)(2)(iii)	1	Timer interval error - greater than 10 percent	A timer interval had an error greater than 10% of the maximum timer interval of the product. Specifically, ***
	5218	21 CFR 1040.20(c)(2)(iv)	1	Timer resetting and causing resumption of radiation emission	The timer was able to automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlampproduct was terminated. Specifically, ***
	5234	21 CFR 1040.20(d)(3)(v)	1	False and misleading/prohibited statements	The label for the sunlamp product contained [statements] [illustrations]which [are false or misleading] [are prohibited by Part 1040]. Specifically, ***
	5240	21 CFR 1040.20(e)(1)(v)	1	Repair/compatible replacement instructions	The users' instructions for the sunlamp product do not contain instructions for [obtaining repairs] [obtaining recommended replacement components and accessories which are compatible with the product] including [compatible protective eyewear] [ultraviolet lamps] [timers] [reflectors] [filters] the proper use of which will result in continued compliance with the standard . Specifically, ***
	5465	21 CFR 1020.30(h)(4)(i)	1	leakage technique factors, beam limiting device	A statement of the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices, for which you state compatibility, was not provided to the users or to others upon request at cost,Specifically, ***
	5472	21 CFR 1020.30(k)	1	Compliance measurements--diagnostic source assembly	Compliance for radiation leakage from the diagnostic source assembly was not determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. Specifically, ***
	5670	21 CFR 1040.10(h)(2)(ii)	1	Reproductions of warnings	Adequate instructions for service adjustments and service procedureswere not provided or caused to be provided for each laser model, including legible reproductions of required labels and hazard warnings. Specifically, ***
	5694	21 CFR 1002.10(d)	1	Description of function, op. characteristics, uses	A product report did not describe the [function] [operational characteristics affecting radiation emission] [intended and known uses of each model] of the listed product. Specifically, ***
	5697	21 CFR 1002.10(a)	1	Identification of listed product	A product report did not [clearly] identify which product was the subject of the report. Specifically, ***
	5749	21 CFR 1020.33(f)(1)	1	CT conditions of operation indicated prior to scan	The CT conditions of operation to be used during a scan or scan sequence are not indicated prior to initiation of the scan or scan sequence. Specifically, ***
	5763	21 CFR 1020.33(c)(3)	1	Performance data for CT conditions of operation - incomplete	Performance data for the CT conditions of operation used to provide the information required by 21 CFR 1020.33(c)(2)(i) [are incomplete] [inaccurate]. Specifically, ***
	5765	21 CFR 1020.33(c)(2)(ii)	1	CTDI for conditions of operation which vary exposure	The computed tomography dose index (CTDI) in the center location of the dosimetry phantom is not provided to users for each selectable condition of operation that varies either the rate or duration of x-ray exposure. Specifically, ***
	5767	21 CFR 1020.33(c)(2)(i)(c)	1	CTDI at 90, 180, 270 degrees	The computed tomography dose index (CTDI) is not provided to users for locations along lines parallel to the axis of rotation and 1.0 cm interior to the surface of the phantom, at positions [90] [180] [270] degrees from the position specified in 21 CFR 1020.33(c)(2)(i)(b). Specifically, ***
	5784	21 CFR 1010.2(b)	1	Certification other than by tag or label	Certification of a product is not in conformance with [the manner prescribed in an applicable standard] [the alternate means approved by FDA]. Specifically, ***
	5811	21 CFR 1002.30(a)(1)	1	Quality control procedures	You have not [established] [maintained] records containing a description of quality control procedures with respect to electronic product radiation safety. Specifically, ***
	5903	21 CFR 1020.30(c)	1	Combination of two or more components	Prior written authorization to certify a combination of two or more components when installed into a diagnostic x-ray system was not obtained from CDRH. Specifically, ***
	5907	21 CFR 1020.30(d)(1)	1	Report of assembly submitted within 15 days	A completedreport of assembly regarding certified components installed in a diagnostic x-ray system was not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation protection] within 15 days following the completion of the assembly. Specifically, ***
	5911	21 CFR 1020.30(h)(2)(i)	1	Tube housing assembly mandatory information	Statements for each tube housing assembly of [the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the tube housing assembly manufacturer states compatibility] [the minimum filtration permanently in the useful beam expressed as millimeters of aluminum equivalent] [the peak tube potential at which the aluminum equivalent was obtained] were not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]Specifically, ***
	5914	21 CFR 1020.30(h)(3)(i)	1	Rated line voltage, range (x-ray control + generator)	A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current was not providedto [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***
	5915	21 CFR 1020.30(h)(3)(ii)	1	Maximum line current (x-ray control + generator)	A statement of the maximum line current of the x-ray system based on the maximum input voltage and output current characteristics of the tube housing assembly compatible with rated output voltage and rated current characteristics of the x-ray control and associated high-voltage generator was not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***
	5919	21 CFR 1020.30(h)(3)(v)	1	Generator rating and duty cycle	A statement of the generator rating and duty cycle was not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***
	5921	21 CFR 1020.30(h)(3)(vi)	1	Fixed technique factors--max deviation from nominal	In the case of fixed technique factors, a statement of the maximum deviation from the nominal fixed value of each factor was not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***
	5923	21 CFR 1020.30(h)(3)(viii)	1	Measurement criteria for technique factors	A statement describing the measurement criteria for all technique factors used was not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***
	5924	21 CFR 1020.30(h)(4)(i)	1	Beam limiting devices--leakage technique factors	Leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the beam-limiting device manufacturer states compatibility are not provided for each variable-aperture beam-limiting device to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically, ***