FY 2010 Inspectional Observation Summaries

 

Number of 483s issued from the System* 

Inspections ending between 10/1/2009 12:00:00 AM and 9/30/2010 12:00:00 AM

* This table does not represent the complete set of 483's issued during the fiscal year as some 483's were manually prepared and not available in this format. The sum of 483's for all Product Areas will be greater than the actual Total 483's 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 483's 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)	529	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)	421	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, ***
	905	21 CFR 123.6(b)	327	HACCP plan implementation	You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, ***
	1306	21 CFR 110.20(b)(7)	315	Screening	Failure to provide adequate screening or other protection against pests.  Specifically, ***
	1422	21 CFR 110.20(b)(4)	307	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)	282	Buildings/sanitary	Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, ***
	1287	21 CFR 110.20(a)(1)	262	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)	256	Buildings/good repair	Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated.  Specifically, ***
	1525	21 CFR 123.11(c)	206	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, ***
	990	21 CFR 110.10(b)(3)	194	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, ***
	1554	21 CFR 110.35(a)	193	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, ***
	1695	21 CFR 110.80(b)(2)	191	Manufacturing conditions	Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].  Specifically, ***
	1701	21 CFR 110.80(b)(7)	189	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, ***
	6004	21 CFR 123.6(c)(4)	186	Monitoring - adequacy	Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit.  Specifically***
	904	21 CFR 123.6(b)	181	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, ***
	1405	21 CFR 110.10(b)(6)	178	Failure to wear	Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.  Specifically, ***
	1007	21 CFR 110.10(b)(9)	174	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, ***
	1427	21 CFR 110.20(b)(5)	174	Safety lighting and glass	Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food.  Specifically, ***
	959	21 CFR 123.6(c)(1)	170	Food safety hazards	Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.  Specifically, ***
	2386	21 CFR 110.80(a)(1)	167	Storage	Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, ***
	908	21 CFR 123.6(d)	165	Signed and dated	Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually].  Specifically, ***
	960	21 CFR 123.6(c)(2)	164	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, ***
	1424	21 CFR 110.20(b)(4)	163	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, ***
	961	21 CFR 123.6(c)(3)	155	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,
	963	21 CFR 123.6(c)(5)	154	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***
	1689	21 CFR 110.80	153	Reasonable precautions	All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
	1556	21 CFR 110.35(b)(2)	152	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, ***
	1562	21 CFR 110.35(d)	142	Failure to clean - general	Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food.  Specifically, ***
	2392	21 CFR 110.80(b)(1)	135	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, ***
	6008	21 CFR 123.8(a)(3)	131	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, ***
	1581	21 CFR 110.37(e)	128	Running water at suitable temperature	Hand-washing facilities lack running water of a suitable temperature.  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, ***
	1292	21 CFR 110.20(b)(1)	121	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, ***
	1597	21 CFR 110.37(b)(3)	116	As source of contamination	Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  Specifically, ***
	1005	21 CFR 110.10(b)(7)	112	Storage of personal items	Personal [clothing] [belongings] were stored  in an area where [food is exposed] [equipment or utensils are washed].  Specifically, ***
	1125	21 CFR 110.40(a)	112	Materials and workmanship	The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, ***
	945	21 CFR 123.12(a)(2)	110	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, ***
	6001	21 CFR 123.11(b)	109	Sanitation monitoring documentation	Your sanitation control records do not accurately document the conditions or practices observed at your firm.  Specifically***
	6020	21 CFR 123.9(a)	103	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, ***
	3661	21 CFR 110.37(e)(5)	94	Signs	Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, ***
	1006	21 CFR 110.10(b)(8)	93	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, ***
	3659	21 CFR 110.37(e)(3)	93	Hand drying	Lack of a sanitary towel service or suitable hand drying devices.  Specifically, ***
	1066	21 CFR 110.40(b)	92	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, ***
	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, ***
	1565	21 CFR 110.35(d)(3)	88	Non-food-contact surfaces (S)	Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination.  Specifically, ***
	933	21 CFR 123.8(a)(2)(ii)	87	Calibration - adequacy	Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, ***
	985	21 CFR 110.10(b)(1)	86	Suitable outer garments	Suitable outer garments are not worn  that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
	6021	21 CFR 123.10	85	HACCP training or qualification	No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.  Specifically, ***
	3652	21 CFR 110.37(e)(1)	83	Suitable locations	Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.  Specifically, ***
	1402	21 CFR 110.10(b)(4)	82	Unsecured jewelry	Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers].  Specifically, ***
	3658	21 CFR 110.37(e)(2)	80	Hand cleaning and sanitizing preparations	Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, ***
	1698	21 CFR 110.80(b)(5)	77	Work-in-progress	Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, ***
	1429	21 CFR 110.20(b)(6)	76	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, ***
	12720	21 CFR 1.225	76	Not registered	Your food facility is not registered as required.  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, ***
	6005	21 CFR 123.6(c)(6)	71	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, ***
	1173	21 CFR 110.40(f)	69	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,***
	1571	21 CFR 110.35(d)(5)	67	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, ***
	1599	21 CFR 110.37(b)(5)	60	Backflow prevention	Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, ***
	1406	21 CFR 110.10(b)(6)	59	Effective use of hair restraint	Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner.  Specifically, ***
	901	21 CFR 123.6(a)	58	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, ***
	3643	21 CFR 110.10(b)(5)	58	Glove condition	Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.  Specifically, ***
	1426	21 CFR 110.20(b)(5)	57	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, ***
	1578	21 CFR 110.37(f)	57	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, ***
6018	21 CFR 123.7(a)	57	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,***
1598	21 CFR 110.37(b)(4)	56	Drainage	Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage.  Specifically, ***
9931	21 CFR 120.6(b)	55	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, ***
906	21 CFR 123.6(b)	54	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, ***
1067	21 CFR 110.40(c)	54	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, ***
1293	21 CFR 110.20(b)(2)	54	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, ***
6007	21 CFR 123.9(a)	54	Records entries - timing	Processing or other information was not [always] entered on your records at the time it was observed.  Specifically, ***
1702	21 CFR 110.80(b)(8)	51	Metal / extraneous materials	Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food.  Specifically, ***
4470	21 CFR 108.25(c)(2)	51	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, ***
1602	21 CFR 110.37(a)	49	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, ***
1596	21 CFR 110.37(b)(2)	46	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, ***
1696	21 CFR 110.80(b)(3)	46	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, ***
1709	21 CFR 110.80(b)(13)	46	Filling, assembling, packing controls	Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated.  Specifically, ***
3656	21 CFR 110.37(d)(3)	46	Self-closing doors	Toilet facilities lack self-closing doors.  Specifically, ***
1570	21 CFR 110.35(d)(5)	45	Safe and adequate for use	Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, ***
3654	21 CFR 110.37(d)(1)	45	Maintained	Failure to maintain toilet facilities in a sanitary condition.  Specifically, ***
2388	21 CFR 110.80(a)(5)	43	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, ***
913	21 CFR 123.8(a)(1)	41	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, ***
1289	21 CFR 110.20(a)(3)	41	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, ***
6015	21 CFR 123.6(c)(6)	41	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, ***
931	21 CFR 123.8(d)	40	Verification - recordkeeping	You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
1128	21 CFR 110.40(a)	38	Installation and maintenance of equipment (S)	Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces].  Specifically, ***
6006	21 CFR 123.6(c)(7)	38	Records values/observations	Your monitoring records do not contain the actual values and observations obtained during monitoring.  Specifically, ***
1763	21 CFR 110.35(b)(1)	36	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, ***
6010	21 CFR 123.8(a)(3)(i)	36	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, ***
3080	21 CFR 114.83	34	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, ***
3647	21 CFR 110.10(c)	34	Training of handlers and supervisors	Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].  Specifically, ***
1132	21 CFR 110.40(a)	32	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, ***
918	21 CFR 123.8(a)	31	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, ***
6019	21 CFR 123.8(a)(2)	31	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, ***
3086	21 CFR 114.100(b)	30	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, ***
1184	21 CFR 110.35(e)	28	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, ***
1403	21 CFR 110.10(b)(4)	28	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, ***
2393	21 CFR 110.80(b)(1)	28	Teardown equipment/thorough cleaning	Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, ***
9930	21 CFR 120.6(c)	28	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, ***
1130	21 CFR 110.40(a)	27	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, ***
932	21 CFR 123.7(d)	25	Corrective action documentation	You do not have records that document corrective actions that were taken.  Specifically, ***
2361	21 CFR 110.80	25	Testing	Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. 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, ***
3655	21 CFR 110.37(d)(2)	24	Good repair	Failure to keep toilet facilities in good repair.  Specifically, ***
1090	21 CFR 110.40(d)	23	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, ***
3073	21 CFR 114.80(a)(2)	23	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, ***
1129	21 CFR 110.40(a)	22	Food-contact - corrosion resistant	Lack of corrosion-resistant food contact surfaces.  Specifically, ***
3712	21 CFR 110.93	22	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, ***
1561	21 CFR 110.35(c)	21	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, ***
2384	21 CFR 110.80(a)(7)	21	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, ***
6009	21 CFR 123.8(a)(3)(iii)	21	Verification - record review - calibration	You did not review [some of] your calibration records within a reasonable time after the records were made.  Specifically, ***
6016	21 CFR 123.6(c)(7)	21	Records system	Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points.  Specifically, ***
1766	21 CFR 110.35(b)(1)	20	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, ***
2396	21 CFR 110.80(b)(6)	20	Conveyor transportation	Failure to take effective measures to protect food transported by conveyor from contamination.  Specifically, ***
3078	21 CFR 114.80(b)	20	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, ***
9941	21 CFR 120.8(a)	20	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, ***
12742	21 CFR 120.8(a)	20	HACCP plan not implemented	You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan.  Specifically, ***
986	21 CFR 110.10(b)(2)	19	Personal cleanliness	Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.  Specifically, ***
2385	21 CFR 110.80(a)(1)	19	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, ***
3071	21 CFR 114.80(a)(1)	19	Scheduled process	Acidified food is not manufactured in accordance with the scheduled process.  Specifically, ***
3657	21 CFR 110.37(d)(4)	19	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, ***
4479	21 CFR 108.25(e)	18	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, ***
6017	21 CFR 123.7(c)	18	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, ***
6022	21 CFR 123.12(c)	18	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, ***
2394	21 CFR 110.80(b)(6)	17	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, ***
9947	21 CFR 120.11(b)	17	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)	17	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, ***
3085	21 CFR 114.100(a)	16	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, ***
3660	21 CFR 110.37(e)(4)	16	Devices and fixtures	Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands.  Specifically, ***
4181	21 CFR 113.89	16	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, ***
4421	21 CFR 110.20(a)	16	Maintenance of grounds	Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, ***
6014	21 CFR 123.6(c)(2)	16	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,
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, ***  .  Specifically, ***
15797	21 CFR 111.553	15	Written procedures - product complaint	You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint.  Specifically, ***
950	21 CFR 123.12(d)	14	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, ***
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, ***
3075	21 CFR 114.80(a)(4)	14	Container testing	Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.  Specifically, ***
3662	21 CFR 110.37(e)(6)	14	Refuse receptacles	Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food.  Specifically, ***
9939	21 CFR 120.7(c)	14	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, ***
9955	21 CFR 120.11(a)(1)	14	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, ***
12745	21 CFR 120.8(b)(1)	14	HACCP plan - food hazards not listed	Your HACCP plan does not list all food hazards that are reasonably likely to occur.  Specifically, ***
1642	21 CFR 113.100(b)	13	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, ***
1708	21 CFR 110.80(b)(12)	13	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, ***
9958	21 CFR 120.12(c)	13	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, ***
15927	21 CFR 111.103	13	Written procedures - quality control operations	You did not [establish] [follow] written procedures for quality control operations.  Specifically, ***
1566	21 CFR 110.35(d)(4)	12	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, ***
3067	21 CFR 114.80(a)	12	Quality control procedures	Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard.  Specifically, "***
3645	21 CFR 110.10(d)	12	Supervision	Responsibility for assuring compliance with current good manufacturing practices relating to personnel  has not been assigned to competent supervisory personnel.  Specifically, ***
3663	21 CFR 110.40(e)	12	Lack of automatic control / alarm (S)	Lack of [an automatic control for regulating  temperature] [an automatic temperature alarm system] for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.  Specifically, ***
4515	21 CFR 108.35(c)(2)	12	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, ***
12747	21 CFR 120.8(b)(3)	12	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, ***
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, ***
975	21 CFR 123.9(b)(1)	11	Record retention	Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period.  Specifically, ***
1288	21 CFR 110.20(a)(2)	11	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, ***
2389	21 CFR 110.80(a)(5)	11	Identify rework	Failure to identify material scheduled for rework as such. Specifically, ***
3082	21 CFR 114.89	11	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, ***
4296	21 CFR 110.80(a)(5)	11	Temperature and humidity	Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated.  Specifically, ***
4464	21 CFR 108.25(c)(1)	11	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, ***
6012	21 CFR 123.8(a)(3)(iii)	11	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, ***
9928	21 CFR 120.12(b)	11	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, ***
9932	21 CFR 120.6(a)	11	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, ***
12721	21 CFR 1.234	11	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, ***
12746	21 CFR 120.8(b)(2)	11	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, ***
15858	21 CFR 111.75(a)(1)(i)	11	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, ***
938	21 CFR 123.9(c)	10	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, ***
1060	21 CFR 123.11(a)	10	SSOP(S)	You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).  Specifically, ***
1601	21 CFR 110.37(a)	10	Safe and adequate sanitary quality	Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.  Specifically, ***
1697	21 CFR 110.80(b)(4)	10	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, ***
3062	21 CFR 114.10	10	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, ***
4475	21 CFR 108.25(c)(3)(i)	10	Process adherence	Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
9919	21 CFR 120.10(a)	10	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, ***
12734	21 CFR 120.12(a)	10	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, ***
12744	21 CFR 120.8(b)(4)	10	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, ***
15532	21 CFR 111.255(b)	10	Batch record - complete	Your batch production record did not include complete information relating to the production and control of each batch.  Specifically, ***
15642	21 CFR 111.455(a)	10	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, ***
15762	21 CFR 111.205(a)	10	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, ***
1196	21 CFR 110.10(a)	9	Employees with illness,  lesions, contamination source	Employees  who 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, ***
1316	21 CFR 113.87(c)	9	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, ***
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, ***
1711	21 CFR 110.80(b)(15)	9	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, ***
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, ***
6002	21 CFR 123.11(b)	9	Sanitation corrections	You did not correct sanitation deficiencies in a timely manner.  Specifically,***
15494	21 CFR 111.25(c)	9	Procedures - equipment - cleaning, sanitizing	You  did 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, ***
972	21 CFR 123.8(a)(1)	8	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)	8	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,***
1290	21 CFR 110.20(a)(4)	8	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, ***
1529	21 CFR 113.89	8	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, ***
1641	21 CFR 113.100(b)	8	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 of  the process] [before shipment or release for distribution] to determine [completeness of the records] [whether product was processed as specified by the scheduled process].  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, ***
3877	21 CFR 113.60(c)	8	Coding - required elements	The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed]  [period during which packed].  Specifically, ***
4179	21 CFR 113.83	8	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, ***
15410	21 CFR 111.14(b)(2)	8	Personnel - records - training	You did not make and keep documentation of training.  Specifically, ***
15763	21 CFR 111.205(a)	8	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, ***
15862	21 CFR 111.75(a)(2)	8	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, ***
16042	21 CFR 111.503	8	Written procedures - returned dietary supplement	You did not [establish] [follow] written procedures for when a returned dietary supplement is received.  Specifically, ***
899	21 CFR 123.16	7	Process controls	Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
1330	21 CFR 113.100(a)	7	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, ***
1665	21 CFR 110.80(a)(2)	7	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	7	Supervisory competence	The function of supervising overall sanitation of the plant has not been designated to  the supervision of  one or more competent individuals assigned responsibility for this function.  Specifically, ***
2427	21 CFR 110.80(b)(9)	7	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, ***
9943	21 CFR 120.8(a)	7	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)	7	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, ***
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, ***
15659	21 CFR 111.475(b)(1)	7	Written procedures - holding; distributing	You did not make and keep written procedures for holding and distributing operations.  Specifically, ***
15839	21 CFR 111.70(e)	7	Specifications - identity, purity, strength, composition	You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement.  Specifically, ***
15869	21 CFR 111.75(c)	7	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, ***
1329	21 CFR 113.100(a)	6	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, ***
1428	21 CFR 110.20(b)(6)	6	Adequate ventilation	Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food.  Specifically, ***
1471	21 CFR 113.83	6	Scheduled processes not established	Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing.  Specifically, ***
1487	21 CFR 113.87(b)	6	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, ***
2887	21 CFR 113.40(j)	6	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, ***
3072	21 CFR 114.80(a)(1)	6	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)	6	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, ***
3090	21 CFR 114.100(d)	6	Product distribution	Records identifying initial distribution of finished product are not maintained.  Specifically, ***
3650	21 CFR 110.35(d)(1)	6	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)	6	Cross contamination	Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing.  Specifically, ***
3857	21 CFR 113.60(a)	6	Record of visual closure examination	Failure to record observations of visual closure examinations performed by a qualified person during production.  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, ***
12733	21 CFR 120.11(a)(1)(iv)(C)	6	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, ***
12743	21 CFR 120.8(b)(4)	6	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, ***
15302	21 CFR 120.11(a)(2)	6	Calibration, testing - no records	You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
15498	21 CFR 111.27(d)	6	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, ***
15641	21 CFR 111.453	6	Written procedures - holding	You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, ***
15853	21 CFR 111.73	6	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, ***
15861	21 CFR 111.75(a)(2)(ii)(A)	6	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, ***
15897	21 CFR 111.83(a)	6	Reserve sample - collect, hold	You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.  Specifically, ***
17004	FDCA 402(a)	6	Food Field Exam	During a field examination of food products at your facility the following [was] [were] observed:
929	21 CFR 123.8(b)	5	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, ***
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, ***
976	21 CFR 123.9(b)(2)	5	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, ***
1040	21 CFR 113.10	5	Operators	Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems] are not under the operating supervision of a person that has attended  and satisfactorily completed, a school approved by the Commissioner.  Specifically, ***
1045	21 CFR 113.10	5	Supervisors	Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility.   Specifically, ***
1639	21 CFR 113.100(b)	5	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, ***
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, ***
2301	21 CFR 129.80(f)	5	Bacteriological contamination of containers and closures (S)	You do not  take 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)	5	Washing and cleaning	Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.  Specifically, ***
2391	21 CFR 110.80(a)(6)	5	Thawed appropriately	Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated.  Specifically, ***
3644	21 CFR 110.10(b)(5)	5	Impermeable (S)	Gloves used for food handling are not impermeable.  Specifically,  ***
3881	21 CFR 113.60(d)	5	Post process handling - automatic equipment design (S)	Automatic equipment used to handle filled containers is not designed or operated so as to preserve the can seam or other container closure integrity.  Specifically, ***
4519	21 CFR 108.35(c)(3)(i)	5	Process adherence	Failure to process each low-acid canned food in conformity with at least the scheduled process. 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, ***
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, ***
15401	21 CFR 111.12(b)	5	Personnel - quality control operations	You have not identified personnel to be responsible for your quality control operations.  Specifically, ***
15402	21 CFR 111.12	5	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, ***
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, ***
15443	21 CFR 111.15(b)(2)	5	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, ***
15454	21 CFR 111.16	5	Written procedures - pest control	You did not [establish] [follow] written procedures for pest control.  Specifically, ***
15550	21 CFR 111.260(j)	5	Batch record - manufacture	Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, ***
15723	21 CFR 111.365(i)	5	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, ***
15736	21 CFR 111.353	5	Manufacturing operations - written procedures	You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, ***
15928	21 CFR 111.103	5	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, ***
16013	21 CFR 111.140(b)(1)	5	Records - quality control operations; responsibilities	You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, ***
977	21 CFR 123.9(b)(3)	4	Records stored at another location	You did not immediately return your records for official review upon demand.  Specifically, ***
1255	21 CFR 129.20(a)	4	Bottling room separation	The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.  Specifically, ***
1473	21 CFR 113.83	4	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.
1500	21 CFR 113.89	4	Evaluation by process authority	Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  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, ***
1643	21 CFR 113.100(c)	4	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)	4	MIG thermometer not used as reference	The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
1670	21 CFR 110.80(a)(4)	4	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, ***
1761	21 CFR 129.80(a)	4	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, ***
1812	21 CFR 129.80(c)	4	Testing of cleaning/sanitizing solutions	You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, ***
1945	21 CFR 129.80(d)	4	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, ***
2362	21 CFR 110.80	4	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, ***
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, ***
3653	21 CFR 110.37(d)	4	Readily accessible	Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, ***
3823	21 CFR 113.40(b)(1)	4	Records of calibration (S)	Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test].  Specifically, ***
15550	21 CFR 111.260(j)	5	Batch record - manufacture	Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, ***
15723	21 CFR 111.365(i)	5	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, ***
15736	21 CFR 111.353	5	Manufacturing operations - written procedures	You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, ***
15928	21 CFR 111.103	5	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, ***
16013	21 CFR 111.140(b)(1)	5	Records - quality control operations; responsibilities	You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, ***
977	21 CFR 123.9(b)(3)	4	Records stored at another location	You did not immediately return your records for official review upon demand.  Specifically, ***
1255	21 CFR 129.20(a)	4	Bottling room separation	The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.  Specifically, ***
1473	21 CFR 113.83	4	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.
1500	21 CFR 113.89	4	Evaluation by process authority	Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  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, ***
1643	21 CFR 113.100(c)	4	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)	4	MIG thermometer not used as reference	The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
1670	21 CFR 110.80(a)(4)	4	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, ***
1761	21 CFR 129.80(a)	4	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, ***
1812	21 CFR 129.80(c)	4	Testing of cleaning/sanitizing solutions	You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, ***
1945	21 CFR 129.80(d)	4	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, ***
2362	21 CFR 110.80	4	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, ***
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, ***
3653	21 CFR 110.37(d)	4	Readily accessible	Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, ***
3823	21 CFR 113.40(b)(1)	4	Records of calibration (S)	Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test].  Specifically, ***
15744	21 CFR 111.210(h)(2)	4	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)	4	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, ***
15761	21 CFR 111.205(b)(1)	4	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, ***
15790	21 CFR 111.403	4	Written procedures - labeling operations	You did not [establish] [follow] written procedures for labeling operations.  Specifically, ***
15819	21 CFR 111.55	4	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, ***
15825	21 CFR 111.65	4	Quality control - quality, dietary supplement	You did not implement quality control operations to ensure the quality of the dietary supplement.  Specifically,  ***
15830	21 CFR 111.70(b)(2)	4	Specifications-component purity, strength, composition	You did not establish component specifications for [purity] [strength] [composition].  Specifically, ***
15872	21 CFR 111.75(c)(3)	4	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, ***
15951	21 CFR 111.110(c)	4	Quality control operations - tests, examinations; results	Your quality control operations did not include reviewing and approving the results of required [tests] [examinations].  Specifically, ***
16083	21 CFR 111.35(b)(6)	4	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, ***
1303	21 CFR 113.81(f)	3	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, ***
1353	21 CFR 129.35(a)(3)(i)	3	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, ***
1379	21 CFR 129.35(a)(4)(iv)	3	Compliance with standards	Finished bottled water does not comply with bottled water quality standards.  Specifically, ***
1483	21 CFR 113.87(a)	3	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, ***
1534	21 CFR 113.100(b)	3	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, ***
1559	21 CFR 110.35(c)	3	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, ***
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, ***
1651	21 CFR 113.40(a)(1)	3	Thermometer calibration	Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy.  Specifically, ***
1734	21 CFR 113.40(a)(2)	3	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, ***
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, ***
1806	21 CFR 129.80(b)(1)	3	Records of mechanical washers	You do not keep records of [inspection and conditions found] [physical maintenance] [performance] for mechanical washers.  Specifically, ***
2056	21 CFR 123.28(a)	3	HACCP plan	Your HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved source.  Specifically, ***
3859	21 CFR 113.60(a)	3	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, ***
3865	21 CFR 113.60(a)(1)	3	Corrective actions following teardown examinations	Failure to note corrective actions taken following teardown examination of double seam cans.  Specifically, ***
3874	21 CFR 113.60(b)	3	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, ***
3875	21 CFR 113.60(b)	3	Cooling water - residual sanitizer (S)	No measurable residual of the cooling water sanitizer at the water discharge point of the container cooler.  Specifically, ***
3892	21 CFR 113.60(a)	3	Regular observations for gross closure defects	Failure to make regular observations for gross closure defects during production runs.  Specifically ***
4465	21 CFR 114.100(c)	3	Process deviations - action to rectify	Failure to record the action taken to rectify a departure from a scheduled process.  Specifically, ***
9946	21 CFR 120.11(b)	3	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, ***
9953	21 CFR 120.11(a)(1)(iv)(A)	3	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, ***
9981	21 CFR 120.12(b)(4)	3	Records - actual values	Your records do not [always] contain the actual values and observations obtained during monitoring.  Specifically, ***
15382	21 CFR 111.8	3	Written procedures - personnel qualifications	You did not [establish] [follow] written procedures for determining personnel qualification requirements.  Specifically, ***
15409	21 CFR 111.14(b)(1)	3	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)	3	Physical plant - clean and sanitary	You did not maintain your physical plant in a clean and sanitary condition.  Specifically, ***
15453	21 CFR 111.16	3	Written procedures - cleaning	You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, ***
15458	21 CFR 111.20(d)(1)(i)	3	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, ***
15491	21 CFR 111.25	3	Equipment - procedures	You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, ***
15492	21 CFR 111.25(a)	3	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, ***
15531	21 CFR 111.255(a)	3	Batch record - every batch	You did not prepare a batch production record every time you manufactured a batch of dietary supplement.  Specifically, ***
15534	21 CFR 111.255(c)	3	Batch record - each step	You did not perform each step in the production of a batch, according to the master production record.  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, ***
15570	21 CFR 111.153	3	Written procedures - components	You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, ***
15572	21 CFR 111.153	3	Written procedures - labels	You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, ***
15604	21 CFR 111.165(b)	3	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?	3	Product received - quarantine	You did not quarantine received product.  Specifically, ***
15675	21 CFR 111.315(b)	3	Sampling plans; establish, follow	You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, ***
15747	21 CFR 111.210(g)	3	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,
15759	21 CFR 111.205(b)(2)	3	Master manufacturing record - controls, procedures	Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,  ***
15778	21 CFR 111.415(b)	3	Dietary supplement - protect, contamination	You did not protect manufactured dietary supplements from contamination during [filling] [assembling] [packaging] [labeling] operations.  Specifically, ***
15791	21 CFR 111.403	3	Written procedures -packaging operations	You did not [establish] [follow] written procedures for packaging operations.  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, ***
15829	21 CFR 111.70(b)(1)	3	Specifications - component identity	You did not establish an identity specification for each component.  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, ***
15842	21 CFR 111.70(f)	3	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, ***
15883	21 CFR 111.75(i)	3	Corrective action plan	You did not establish a corrective action plan to use when an established specification is not met.  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, ***
15935	21 CFR 111.105(d)	3	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, ***
15944	21 CFR 111.105(i)	3	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, ***
15984	21 CFR 111.123(a)(8)	3	Quality control - finished batch, distribution	Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution.  Specifically, ***
16057	21 CFR 111.535(b)(1)	3	Records - returned dietary supplement: written procedures	You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.  Specifically, ***
16070	21 CFR 111.35(b)(2)	3	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, ***
16071	21 CFR 111.35(b)(3)	3	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, ***
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, ***
1093	21 CFR 110.40(g)	2	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)	2	Lack of instruction/reporting of health conditions	Personnel with  adverse health conditions are not instructed to report to their supervisors.  Specifically, ***
1277	21 CFR 129.20(d)	2	Enclosed room for container washing and sanitizing	You do not [wash] [sanitize] containers for bottled drinking water in an enclosed room.  Specifically, ***
1294	21 CFR 110.20(b)(3)	2	Outdoor fermentation	Proper precautions to protect food in outdoor bulk fermentation vessels cannot be taken because of deficiencies in plant [construction] [design].  Specifically, ***
1331	21 CFR 113.100(a)(1)	2	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, ***
1351	21 CFR 129.35(a)(3)(i)	2	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, ***
1394	21 CFR 129.37(a)	2	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, ***
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, ***
1533	21 CFR 113.100(b)	2	RTC identification	Recording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed].  Specifically ***
1595	21 CFR 110.37(b)(1)	2	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, ***
1648	21 CFR 113.40(a)(1)	2	No MIG thermometer	Failure to install a mercury-in glass thermometer on each retort.  Specifically, ***
1735	21 CFR 113.40(a)(2)	2	Unauthorized adjustment	There was no means to prevent unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
1757	21 CFR 113.40(a)(8)	2	Observable	Failure to install bleeders so that the operator can observe that they are functioning properly.  Specifically, ***
1944	21 CFR 129.80(d)	2	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, ***
2115	21 CFR 113.40(b)(8)	2	Drain valve	Failure to install a [nonclogging] [water tight] drain valve [with screened openings].  Specifically, ***
2142	21 CFR 113.40(b)(1)	2	No MIG thermometer	Failure to install a mercury-in glass thermometer on each retort.  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, ***
2272	21 CFR 129.80(e)	2	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, ***
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, ***
2274	21 CFR 129.80(g)(1)	2	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, ***
2321	21 CFR 113.40(c)(2)	2	Unauthorized adjustment	There was no means of preventing unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
2367	21 CFR 129.80(a)	2	Effective treatment	Your treatment of product water is not done in such a manner as to be effective in accomplishing the intended purpose.  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, ***
2848	21 CFR 113.40(g)(1)(i)(b)	2	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, ***
2870	21 CFR 113.40(g)(1)(ii)(e)	2	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 ***
2901	21 CFR 113.40(i)	2	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)	2	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,  ***
3083	21 CFR 114.89	2	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, ***
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, ***
3093	21 CFR 114.89	2	Process deviation evaluation - record	Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations].  Specifically, ***
3648	21 CFR 110.20(a)(4)	2	Neighboring grounds	Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control.  Specifically, ***
3709	21 CFR 110.80(a)(1)	2	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, ***
4530	21 CFR 114.100(c)	2	Process deviations - product disposition	Failure to record the disposition of product involved in a departure from a scheduled process.  Specifically, ***
6011	21 CFR 123.8(a)(3)(ii)	2	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, ***
9921	21 CFR 120.10(b)	2	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, ***
9929	21 CFR 120.12(b)(4)	2	Records - information not entered when observed	Processing and other information is not [always] entered on your records at the time it is observed.  Specifically, ***
9964	21 CFR 120.25	2	Finished product not analyzed for E.coli	You do not [always] analyze your finished juice product for biotype I Escherichia coli.   Specifically, ***
12703	21 CFR 129.80(a)	2	Product samples	You do not take product water samples after processing and prior to bottling.  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, ***
12717	21 CFR 129.80(h)	2	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)	2	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, ***
15001	21 CFR 113.60(a)	2	Corrective actions	When a teardown examination revealed gross closure defects, [adequate] corrective action was not taken.  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, ***
15338	21 CFR 80.38(a)	2	Label with certified lot number	Immediately after notification that a batch of color additive has been certified, the person requesting certification did not label the batch with the certified lot number.  Specifically, ***
15351	FDCA 761(b)(1)	2	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, ***
15391	21 CFR 111.10(b)(3)	2	Hand washing	Your personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing facility [before starting work] [at any time when the hands may have become soiled or contaminated].  Specifically, ***
15403	21 CFR 111.12(b)	2	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, ***
15404	21 CFR 111.12(c)	2	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, ***
15429	21 CFR 111.15(k)	2	Sanitation supervisors - assigned	You did not assign one or more employees to supervise overall sanitation.  Specifically, ***
15456	21 CFR 111.20(b)	2	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)	2	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)	2	Physical plant - screening against pests	Your physical plant did not use adequate screening or other protection against pests.  Specifically, ***
15499	21 CFR 111.27(a)	2	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, ***
15544	21 CFR 111.260(d)	2	Batch record - component; unique identifier	Your batch production records did not include the unique identifier that you assigned to [a component] [a product that you received from a supplier for packaging or labeling as a dietary supplement] [the packaging used] [the label used].  Specifically, ***
15547	21 CFR 111.260(g)	2	Batch record - results; monitoring	Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,  ***
15552	21 CFR 111.260(j)(2)	2	Batch record - initials; each step	Your batch production records did not include initials of the persons performing each step.  Specifically, ***
15562	21 CFR 111.260(l)(1)	2	Batch record - quality control review; production	Your batch production records did not include documentation that quality control personnel reviewed the batch production record.  Specifically, ***
15579	21 CFR 111.155(c)(1)	2	Components - representative samples	You did not collect representative samples of components while the components were quarantined.  Specifically, ***
15582	21 CFR 111.155(e)	2	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)	2	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, ***
15598	21 CFR 111.160(d)(1)	2	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, ***
15619	21 CFR 111.180(b)(1)	2	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)	2	Hold - mixup, contamination, deterioration	You held [components] [dietary supplements] [packaging] [labels] under conditions that  lead to mix-up, contamination, or deterioration. Specifically, ***
15648	21 CFR 111.465(a)(2)	2	Hold - reserve sample; closure system	Your reserve sample of a dietary supplement was not held using the same container-closure system in which the packaged and labeled dietary supplement was distributed.  Specifically, ***
15702	21 CFR 111.320(b)	2	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, ***
15708	21 CFR 111.325(a)	2	Written procedures, laboratory operations	You did not make and keep written procedures for laboratory operations. Specifically, ***
15712	21 CFR 111.325(b)(2)(ii)	2	Records - document; results	The documentation for laboratory tests and examinations did not include the results of the testing and examination.  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, ***
15752	21 CFR 111.210(c)	2	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, ***
15768	21 CFR 111.420(c)	2	Repackaged, relabeled - quality control: approve, rejects	Your quality control personnel did not approve or reject each batch of [repackaged] [relabeled] dietary supplement prior to its release for distribution.  Specifically, ***
15771	21 CFR 111.415(h)	2	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, ***
15775	21 CFR 111.415(e)	2	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, ***
15776	21 CFR 111.415(d)	2	Packaging, labeling - physical separation	You did not establish physical or spatial separation of [packaging] [label] operations from operations on other components and dietary supplements to prevent mix-ups.  Specifically, ***
15780	21 CFR 111.415	2	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, ***
15786	21 CFR 111.410(b)	2	Labels - issuance, use	You did not control the [issuance] [use] of labels, Specifically, ***
15796	21 CFR 111.430(b)	2	Records - packaging, labeling operations	You did not make and keep records of the written procedures for [packaging] [labeling] operations.  Specifically, ***
15799	21 CFR 111.560(a)(1)	2	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, ***
15809	21 CFR 111.570(b)(1)	2	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, ***
15811	21 CFR 111.570(b)(2)(i)	2	Record - person document; time of performance	The person who performed a requirement relating to product complaints did not document, at the time of performance, that the requirement was performed.   Specifically, ***
15817	21 CFR 111.570(b)(2)(ii)(F)	2	Record - product complaint; findings	The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken].  Specifically, ***
15828	21 CFR 111.70(a)	2	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, ***
15831	21 CFR 111.70(b)(3)	2	Specifications - contamination limits	You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, ***
15838	21 CFR 111.70(d)	2	Specifications - labels, packaging	You did not establish [label] [packaging] specifications.  Specifically, ***
15840	21 CFR 111.70(e)	2	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, ***
15841	21 CFR 111.70(f)	2	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,
15868	21 CFR 111.75(b)(2)	2	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, ***
15870	21 CFR 111.75(c)(1)	2	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, ***
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, ***
15875	21 CFR 111.75(d)(1)	2	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, ***
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 be  packaged 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, ***
15932	21 CFR 111.105(a)	2	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, ***
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, ***
15939	21 CFR 111.105(g)	2	Quality control - reserve samples	Your quality control personnel did not ensure that required reserve samples were collected and held.  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,  ***
15989	21 CFR 111.127	2	Quality control operations - packaging, labeling	You do not have quality control operations for [packaging] [labeling].  Specifically, ***
15999	21 CFR 111.127(h)	2	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, ***
16051	21 CFR 111.525(b)	2	Returned dietary supplement - release	Your quality control personnel did not approve or reject the release for distribution of a returned dietary supplement that was reprocessed.  Specifically, ***
16058	21 CFR 111.535(b)(2)	2	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, ***
16072	21 CFR 111.35(b)(3)	2	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, ***
16089	FDCA 417(d)(1)(A)	2	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, ***
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, ***
948	21 CFR 123.12(b)	1	Competent third party	The third party hired to assist with or perform some or all of your importer verification activities lacks the qualifications to perform those activities.  Specifically, ***
1245	21 CFR 113.81(a)	1	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, ***
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 ***
1260	21 CFR 129.20(a)	1	Conveyor openings minimal	Conveyor openings in the bottling room exceed the size required to permit passage of containers. Specifically, ***
1273	21 CFR 129.20(b)	1	Non-sealed system	You do not conduct processing operations in a sealed system under pressure, and you do not provide [adequate] protection against contamination of the water and the system.  Specifically, ***
1276	21 CFR 129.20(c)	1	Adequate ventilation	The ventilation in the [processing room] [bottling room] [container washing and sanitizing area] is not adequate to minimize condensation.  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, ***
1301	21 CFR 113.81(d)	1	Exhausting	The exhausting of containers for removal of air is not controlled to meet the conditions for which the process was designed.  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, ***
1317	21 CFR 113.87(d)	1	Timing devices	Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved.  Specifically, ***
1320	21 CFR 113.87(g)	1	Bleeder mufflers	Failure to keep on file evidence that mufflers on [bleeders] [the vent system] are operating in a manner that does not impede the removal of air .  Specifically, ***
1324	21 CFR 113.100(d)	1	Distribution record	Distribution records are not maintained to identify the initial distribution of the finished product.  Specifically, ***
1359	21 CFR 129.35(a)(3)(i)	1	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, ***
1381	21 CFR 129.35(b)	1	Free of oil, dust, rust, etc.	Air under pressure that is directed at [product water] [a product water-contact surface] is not free of [oil] [dust] [rust] [excessive moisture] [extraneous materials].  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, ***
1417	21 CFR 129.37(c)	1	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, ***
1453	21 CFR 129.40(a)(1)	1	Suitability - equipment and utensils	Not all plant equipment and utensils are suitable for their intended use.  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, ***
1472	21 CFR 113.83	1	Critical factors not stated	Critical factors that may affect the scheduled process are not specified in the scheduled  process.  Specifically, ***
1474	21 CFR 113.83	1	Calculations not performed	Calculations used to determine heat sterilization processes were not performed according to procedures recognized by competent processing authorities.  Specifically, ***
1475	21 CFR 113.83	1	Incubation tests - number of commercial runs (S)	Incubation tests for confirmation of the scheduled process did not include containers from each of four or more actual commercial production runs.  Specifically, ***
1485	21 CFR 113.87(a)	1	Scheduled processes not available	Scheduled processes were not readily available to the [retort or processing system supervisor] [FDA Investigator].  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, ***
1501	21 CFR 113.89	1	Evaluation records	No records were made of the [procedures] [results] of the evaluation done by a process authority following a deviation from the scheduled process.  Specifically, ***
1502	21 CFR 113.89	1	Failure to reprocess or destroy product found underprocessed	Failure to fully reprocess or destroy product determined by a competent processing authority not to have received a thermal process sufficient to render it free of microorganisms of potential public health significance.  Specifically, ***
1532	21 CFR 113.100(a)(7)	1	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, ***
1563	21 CFR 110.35(d)(1)	1	Low-moisture food requirements	Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use.  Specifically, ***
1569	21 CFR 110.35(d)(2)	1	Continuous operations	Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary.  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, ***
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, ***
1691	21 CFR 113.40(a)(4)	1	Steam controller	Failure to equip retorts with automatic steam controllers to maintain retort temperatures.  Specifically, ***
1732	21 CFR 113.40(a)(2)	1	Range	Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature.  Specifically, ***
1740	21 CFR 113.40(a)(2)	1	Well bleeder	Failure to have a 1/16-inch or larger bleeder.  Specifically, ***
2057	21 CFR 123.28(c)	1	Harvest licensure	You do not have controls to ensure that the shellstock you receive [is from a harvester that is in compliance with licensure requirements or from a processor certified by a shellfish control authority] [has a tag affixed to each container or is accompanied by a bill of lading or similar document with specific information]. Specifically, ***
2058	21 CFR 123.28(c)	1	Tag requirements - shellstock	The tags attached to each container of shellstock you receive do not [always] bear [the place and date the shellfish were harvested] [the type and quantity of shellfish] [an identification of the harvester].  Specifically, ***
2059	21 CFR 123.28(d)	1	Labels - shucked shellfish	You do not have controls in place to ensure that shucked molluscan shellfish are in containers that bear a label that discloses [the date and place they were harvested] [the type and quantity of shellfish] [by whom they were harvested].  Specifically, ***
2065	21 CFR 123.28(c)	1	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, ***
2067	21 CFR 123.28(d)	1	Records - shucked shellfish	You do not maintain records of shucked molluscan shellfish that document the [date of receipt] [quantity and type of shellfish] [name and certification number of the packer or repacker of the product].  Specifically, ***
2101	21 CFR 113.40(a)(13)	1	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 specified  in the scheduled process.  Specifically, ***
2103	21 CFR 113.40(a)(13)(ii)	1	Closing vacuum	Closing machine vacuum is not [observed] [recorded] at intervals of sufficient frequency to ensure that the vacuum is as specified  in the scheduled process.  Specifically, ***
2143	21 CFR 113.40(b)(1)	1	Scale and range	A mercury-in-glass thermometer [lacked divisions readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale].  Specifically, ***
2144	21 CFR 113.40(b)(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, ***
2149	21 CFR 113.40(b)(1)	1	Not used as reference	A mercury-in-glass thermometer was not the reference instrument used for indicating processing temperatures.   Specifically, ***
2151	21 CFR 113.40(b)(2)	1	Range	Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature.  Specifically, ***
2167	21 CFR 113.40(b)(9)	1	No indicator	There is no means to determine the water level in a retort during operations.  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, ***
2221	21 CFR 113.40(b)(10)(i)	1	Check valve	There is no check valve provided in the air supply line to prevent water from entering the air supply line.  Specifically, ***
2275	21 CFR 129.80(g)(2)	1	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, ***
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, ***
2309	21 CFR 113.40(c)(1)	1	Unreadable thermometer	Mercury-in-glass thermometers were not installed where they can be accurately and easily read.  Specifically, ***
2329	21 CFR 113.40(c)(5)	1	Size, fully open	Bleeders are [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time].  Specifically, ***
2336	21 CFR 113.40(c)(5)	1	Condensate bleeder	The condensate bleeder was not checked with sufficient frequency to ensure removal of condensate or equipped with an automatic alarm system for the continuous monitoring of condensate bleeder functioning.  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, ***
2499	21 CFR 113.40(e)(2)	1	Presence and accuracy	Each retort did not have an accurate temperature-recording device.  Specifically, ***
2513	21 CFR 113.40(e)(7)	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, ***
2526	21 CFR 113.40(f)(1)	1	No MIG thermometer	Each retort did not have a mercury-in glass thermometer (MIG).   Specifically ***
2843	21 CFR 113.40(g)(1)(i)(a)	1	Not used as reference	The temperature-indicating device was not used as the reference instrument for indicating  processing temperatures.  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, ***
2864	21 CFR 113.40(g)(1)(ii)(b)	1	Process deviations per 113.89	Process deviations are not handled in accordance with 21 CFR 113.89.  Specifically, ***
2886	21 CFR 113.40(i)	1	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, ***
2888	21 CFR 113.40(j)	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, ***
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 devices  were not used to record [sterilization media flow rates] [temperature] [concentration] [factors specified in the scheduled process] for container sterilizing, filling, and closing operations.   Specifically, ***
2896	21 CFR 113.40(g)(2)(ii)(b)	1	Process deviations per 113.89	Product packaged below scheduled process specifications was not [segregated] [handled in accordance with 21 CFR 113.89].  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, ***
3649	21 CFR 110.35(d)(1)	1	Dry and sanitary	Failure to keep food-contact surfaces used in the [manufacture] [holding] of low-moisture food in a dry, sanitary condition at the time of use.  Specifically, ***
3708	21 CFR 110.80(a)(1)	1	Water quality -- wash, rinse, convey food	Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].  Specifically, ***
3711	21 CFR 110.80(b)(17)	1	Non-human foods or inedible products (S)	Manufacture of [animal feed] [inedible product] in [areas] [equipment] used for manufacture of human food, where there is a reasonable possibility of contamination of human food.  Specifically, ***
3771	21 CFR 113.40(a)(7)	1	Location of steam spreader perforations (S)	Perforations in the steam spreader along the bottom of the retort  are not located along the top 90 degrees of the steam spreader.  Specifically, ***
3801	21 CFR 113.40(b)(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, ***
3804	21 CFR 113.40(a)(2)	1	Air filtration for temperature controllers (S)	Failure to have adequate filter systems to ensure a supply of clean, dry air to air-operated temperature controllers.  Specifically, ***
3856	21 CFR 113.60(a)	1	Visual	Failure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of a can randomly selected from each seaming head] [the closure of a typical container].  Specifically ***
3860	21 CFR 113.60(a)	1	Pertinent observations	Failure to record all pertinent visual closure observations.  Specifically, ***
3863	21 CFR 113.60(a)(1)	1	Frequency of teardown examinations (S)	Teardown examinations of double seam cans (and recording of the results) were performed at intervals exceeding four hours.  Specifically, ***
3864	21 CFR 113.60(a)(1)	1	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, ***
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, ***
4178	21 CFR 113.83	1	Commercial production variations	Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process.  Specifically, ***
4180	21 CFR 113.87(b)	1	Record of visual checks (S)	Failure to make a written record of the visual checks of heat sensitive indicators.  Specifically, ***
4419	21 CFR 110.10(c)	1	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, ***
4512	21 CFR 108.25(g)	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] [specified in 21 CFR 114]. Specifically, ***
4514	21 CFR 108.35(c)(1)	1	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, ***
4517	21 CFR 108.35(c)(2)(ii)	1	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, ***
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, ***
4528	21 CFR 108.35(c)(2)(ii)	1	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, ***
4529	21 CFR 108.35(c)(2)(ii)	1	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, ***
6003	21 CFR 123.28(b)	1	Harvest controls	You do not ensure that raw molluscan shellfish being processed are obtained from growing waters approved for harvesting by a shellfish control authority.  Specifically***
6023	21 CFR 123.28(c)	1	Bulk shellstock - harvest information	The bulk shipments of shellstock you receive are not [always] accompanied by a bill of lading or similar document that identifies [the date and place the shellfish were harvested] [the type and quantity of shellfish] [by whom the shellfish were harvested].  Specifically, ***
9792	21 CFR 106.30(b)(3)	1	Stability analysis	Failure to conduct stability analysis on representative samples of finished product batches.  Specifically, ***
9799	21 CFR 106.100(d)	1	Premix supplier	Failure to maintain records of the results of all testing conducted to provide certificates and guarantees concerning nutrient premixes for infant formulas.   Specifically, ***
9832	21 CFR 107.20(c)	1	"Use by" date	Failure to provide a "Use by ____" date on an infant formula label.  Specifically, ***
9933	21 CFR 120.6(b)	1	GMP correction - timely	You do not [always] correct deficiencies from good manufacturing practice in a timely manner.  Specifically, ***
9938	21 CFR 120.7(d)	1	Hazard analysis - evaluation of effect on safety (S)	You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended consumer.  Specifically, ***
9949	21 CFR 120.11(b)	1	HACCP plan not modified	You did not immediately modify your HACCP plan  after a validation revealed that the plan was no longer adequate.  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, ***
9963	21 CFR 120.24(c)	1	Process controls - exempt process, single facility	You do not process and perform final product packaging in a single facility operating under current good manufacturing practices.  Specifically, ***
12701	21 CFR 129.35(a)(4)(iii)	1	Testing for disinfectants & DBPs	Your [product] [operations] source water from a non-public source has been treated with a chlorine-based disinfectant or ozone, but has not been tested for residual disinfectants and disinfection by-products that are likely to result from such treatment.  Specifically, ***
12707	21 CFR 129.80(g)(3)	1	Records of analyses	For analyses of bottled water, you do not maintain records of [date of sampling] [type of product] [production code] [results].  Specifically, ***
12709	21 CFR 129.80(c)	1	Records of cleaning/sanitizing solutions	You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions.  Specifically, ***
12750	21 CFR 120.8(b)(6)	1	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, ***
12754	21 CFR 120.11(a)(1)(iv)(C)	1	Calibration, testing - record review adequacy	Your review of [calibration of process monitoring instruments] [periodic end-product testing] [periodic in-process testing] records does not ensure that [the records are complete] [the activities occurred in accordance with your written procedures].  Specifically, ***
15301	21 CFR 120.24(b)	1	Process controls - citrus	The surface treatments on your citrus fruit do not ensure a 5 log reduction in the most resistant microorganism of public health significance because [the process begins before culling and cleaning] [the fruit is not tree picked] [the 5 log pathogen reduction is not performed in a single facility].  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 comprising  the 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, ***
15322	21 CFR 74 subpart C	1	Color additives intended for use in cosmetics	A color additive subject to certification intended for use in the manufacture of a cosmetic is not from a certified batch. Specifically, ***
15352	FDCA 761(b)(1)	1	No label copy submitted with AE report (dietary supplement)	Copies of labels from on or within the retail package of a dietary supplement did not accompany serious drug event report. Specifically, ***
15358	FDCA 761(c)(1)	1	Timing of AE report submission (dietary supplement)	An adverse event report for a dietary supplement was not submitted to the Secretary of HHS within 15 business days of receipt of the report,. Specifically, ***
15381	21 CFR 111.8	1	Written procedures - hygienic practices	You did not [establish] [follow] written procedures for hygienic practices.  Specifically, ***
15388	21 CFR 111.10(b)	1	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, ***
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, ***
15393	21 CFR 111.10(b)(4)	1	Hand jewelry - remove	Your personnel did not remove hand jewelry that cannot be adequately sanitized during periods in which components or  dietary supplements are manipulated by hand.  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, ***
15396	21 CFR 111.10(b)(6)	1	Hair restraints	Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, ***
15411	21 CFR 111.14(b)(2)	1	Personnel - records - training date, type, persons	Your training documentation did not include the [date of the training] [type of training] [persons trained].  Specifically, ***
15423	21 CFR 111.15(j)	1	Trash disposal	You did not convey, store, and dispose of trash to [minimize development of odors] [minimize potential for the trash to attract, harbor, or become a breeding place for pests] [protect against contamination of components, dietary supplements, contact surfaces, water supplies, and grounds surrounding your physical plant] [control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces].  Specifically, ***
15431	21 CFR 111.15(e)(1)	1	Water supply - not component - suitability	Water that does not become a component of the dietary supplement was not [safe and sanitary] [at suitable temperature] [under appropriate pressure] for all uses.  Specifically, ***
15433	21 CFR 111.15(d)(1)	1	Animals and pests in facility	You allowed [animals] [pests] in your physical plant. Specifically, ***
15444	21 CFR 111.15(c)(1)	1	Cleaning compounds	You did not use cleaning compounds that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use].  Specifically, ***
15447	21 CFR 111.15(c)(3)	1	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, ***
15452	21 CFR 111.15(f)(5)	1	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)	1	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, ***
15473	21 CFR 111.20(c)(7)	1	Physical plant - separate areas - holding	You [did not have] [did not use] separate or defined areas of adequate size or other control systems prevent contamination or mix-ups of components or dietary supplements during holding operations.  Specifically, ***
15482	21 CFR 111.23(c)	1	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, ***
15493	21 CFR 111.25(b)	1	Procedures - calibrating automated, mechanical equip	You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.  Specifically, ***
15507	21 CFR 111.27(a)(5)(i)	1	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, ***
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, ***
15526	21 CFR 111.30(c)	1	Equipment - automated - calibrate, inspect	You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance.  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, ***
15529	21 CFR 111.30(e)	1	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)	1	Batch record - follow master	Your batch production record did not accurately follow the appropriate master manufacturing record.  Specifically, ***
15536	21 CFR 111.255(d)	1	Batch record - originals, copies, electronic	You did not keep batch production records as original records, true copies, or as electronic records.  Specifically, ***
15542	21 CFR 111.260(b)	1	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, ***
15543	21 CFR 111.260(c)	1	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, ***
15554	21 CFR 111.260(j)(2)(ii)	1	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, ***
15557	21 CFR 111.260(k)	1	Batch record - packaging, labeling	Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations.  Specifically, ***
15559	21 CFR 111.260(k)(1)	1	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, ***
15561	21 CFR 111.260(k)(3)	1	Batch record - tests, examinations; results	Your batch production records did not include the results of any tests or examinations conducted on packaged and labeled dietary supplements or a cross-reference to the physical location of such results.  Specifically, ***
15565	21 CFR 111.260(l)(2)	1	Batch record - reprocessing, repackaging	Your batch production records did not include documentation that quality control personnel approved or rejected [reprocessing] [repackaging].  Specifically, ***
15566	21 CFR 111.260(l)(3)	1	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, ***
15571	21 CFR 111.153	1	Written procedures - packaging	You did not [establish] [follow] written procedures for the requirements for packaging received.  Specifically, ***
15573	21 CFR 111.153	1	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, ***
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, ***
15580	21 CFR 111.155(c)(2)	1	Quality control - components; tests, examination results	Your quality control personnel did not review and approve the results of [tests] [examinations] conducted on components while the components were quarantined. Specifically, ***
15583	21 CFR 111.155(d)(1)	1	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,  ***
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, ***
15589	21 CFR 111.160(c)	1	Packaging, labels - quarantine	You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement.  Specifically, ***
15592	21 CFR 111.160(c)(1)	1	Packaging - visual identification; containers, closures	You did not conduct a visual identification of the immediate containers and closures of packaging while the packaging was quarantined.  Specifically, ***
15597	21 CFR 111.160(c)(3)	1	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)	1	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, ***
15602	21 CFR 111.160(e)	1	Packaging, labels - mixups	You did not hold [packaging] [labels] under conditions that will avoid mix-ups.  Specifically, ***
15607	21 CFR 111.165(c)(2)	1	Product received - quality control; documentation; specs	Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.  Specifically,  ***
15608	21 CFR 111.165(c)(3)	1	Product received - quality control; approve	Your quality control personnel did not approve quarantined received product for [packaging] [labeling] as a dietary supplement. Specifically, ***
15609	21 CFR 111.165(c)(3)	1	Product received - quality control; quarantine; release	Your quality control personnel did not release received product from quarantine for [packaging] [labeling] as a dietary supplement.  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, ***
15614	21 CFR 111.170	1	Quarantine  component, 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, ***
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,  ***
15623	21 CFR 111.180(b)(2)	1	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,  ***
15624	21 CFR 111.180(b)(3)	1	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, ***
15630	21 CFR 111.180(b)(3)(i)	1	Document - required operation	The person who performed a required operation did not document, at the time of performance, that the required operation was performed.  Specifically, ***
15646	21 CFR 111.460(a)	1	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, ***
15660	21 CFR 111.475(b)(2)	1	Records - product distribution	You did not make and keep records of product distribution.  Specifically, ***
15662	21 CFR 111.303	1	Written procedures - laboratory operations	You did not [establish] [follow] written procedures for laboratory operations. 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 control  processes - requirements	You did not [establish] [follow] laboratory control processes.  Specifically, ***
15672	21 CFR 111.315	1	Laboratory control  processes - reviewed, approved	The laboratory control processes that you established and followed were not reviewed and approved by quality control personnel. Specifically, ***
15679	21 CFR 111.315(b)(1)	1	Laboratory control  processes - sampling plans; packaging	You did not [establish] [follow] sampling plans for obtaining representative samples of packaging.  Specifically, ***
15683	21 CFR 111.315(c)	1	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, ***
15689	21 CFR 111.315(b)(3)	1	Sampling plans; finished batches	You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of dietary supplements.  Specifically,  ***
15693	21 CFR 111.315(b)(1)	1	Laboratory control  processes - sampling plans; labeling	You did not [establish] [follow] sampling plans for obtaining representative samples of labels.  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, ***
15728	21 CFR 111.365(d)	1	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	1	Manufacturing operations - sanitation	You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, ***
15735	21 CFR 111.355	1	Manufacturing operations - design	You did not design or select manufacturing processes that ensure that product specifications are consistently met.  Specifically, ***
15743	21 CFR 111.210(h)(3)	1	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)	1	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, ***
15749	21 CFR 111.210(e)	1	Master manufacturing record - intentional overage	Your master manufacturing record did not include a statement of intentional overage amount of a dietary ingredient.  Specifically, ***
15754	21 CFR 111.210(a)	1	Master manufacturing record - dietary ingredients	Your master manufacturing record did not include the [name] [strength] [concentration] [weight] [measure] of each dietary ingredient for each batch size.  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, ***
15760	21 CFR 111.205(b)(1)	1	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, ***
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, ***
15784	21 CFR 111.410(c)	1	Packaging, labels - master manufacturing record	You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of dietary supplement to determine whether the [packaging] [labels] conformed to the master manufacturing record.  Specifically, ***
15785	21 CFR 111.410(b)	1	Label, packaging - discrepancies	You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].  Specifically,  ***
15787	21 CFR 111.410(b)	1	Packaging - issuance, use	You did not control the [issuance] [use] of packaging.  Specifically, ***
15800	21 CFR 111.560(a)(2)	1	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, ***
15802	21 CFR 111.560(c)	1	Product complaint - review, investigation	Your review and investigation of a product complaint did not extend to all relevant batches and records.  Specifically, ***
15806	21 CFR 111.570(a)	1	Records - product complaints:  originals, copies, electroni	You did not keep the records required for product complaints as original records, true copies, or as electronic records.  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, ***
15820	21 CFR 111.55	1	Production, process controls - packaged, labeled	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 that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, ***
15821	21 CFR 111.60(a)	1	Production, in- process control system - design, quality	Your production and in-process control system is not designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement.  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, ***
15826	21 CFR 111.65	1	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, ***
15834	21 CFR 111.70(c)(2)	1	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, ***
15843	21 CFR 111.70(g)	1	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, ***
15845	21 CFR 111.73	1	Specifications met - quality	You did not determine whether you met specifications established to ensure the quality of the dietary supplement.  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 met  in-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, ***
15864	21 CFR 111.75(a)(2)(ii)(C)	1	Documentation - qualify supplier	You did not maintain documentation of how you qualified the supplier of a component.  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, ***
15878	21 CFR 111.75(e)	1	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, ***
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, ***
15885	21 CFR 111.77(a)	1	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, ***
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, ***
15901	21 CFR 111.83(b)(3)	1	Reserve sample - retained	You did not retain reserve samples for the required time.  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,
15908	21 CFR 111.90(b)(1)	1	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, ***
15920	21 CFR 111.95(b)(1)	1	Records - established specifications	You did not make and keep records of established specifications.  Specifically, ***
15922	21 CFR 111.95(b)(3)	1	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, ***
15930	21 CFR 111.105	1	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, ***
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, ***
15945	21 CFR 111.105(i)	1	QC - required operations packaging/labeling operations	Your quality control personnel did not perform required operations for [packaging] [labeling] operations. 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, ***
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, ***
15955	21 CFR 111.113(a)(3)	1	Quality control - adulteration; material review, disposition	Your quality control personnel did not conduct a material review and make a disposition decision for an unanticipated occurrence during the manufacturing operations that adulterated or may lead to adulteration of the [component] [dietary supplement] [packaging].  Specifically, ***
15963	21 CFR 111.113(b)(2)	1	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, ***
15966	21 CFR 111.117(a)	1	Quality control operations - calibrating processes	Your quality control operations did not include reviewing and approving all processes for calibrating instruments and controls.  Specifically, ***
15973	21 CFR 111.120(c)	1	QC operations - material review, disposition decision	Your quality control operations did not include conducting a required material review and making a required disposition decision for [components] [packaging] [labels] prior to [their] use.  Specifically, ***
15975	21 CFR 111.120(e)	1	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)	1	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, ***
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, ***
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, ***
16007	21 CFR 111.135	1	Quality control operations - product complaints	You do not have quality control operations for product complaints.  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, ***
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, ***
16025	21 CFR 111.140(b)(3)(vii)	1	material review, disposition, follow-up; signature	Your documentation of your material review and disposition decision and follow-up did not include the signature [of the individual designated to perform the quality control operation] [of each qualified individual who provides information relevant to that material review and disposition decision].  Specifically, ***
16037	21 CFR 111.605	1	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, ***
16040	21 CFR 111.610(a)	1	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, ***
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, ***
16053	21 CFR 111.535(a)	1	Records - returned dietary supplement:  1 year, 2 years	You did not keep the records required for returned dietary supplements for the required time period.  Specifically, ***
16060	21 CFR 111.535(b)(4)	1	Returned dietary supplement: reevaluation, determination	You did not make and keep records [of documentation of the reevaluation by quality control personnel of a dietary supplement that was reprocessed] [of the determination by quality control personnel of whether the reprocessed dietary supplement met established product specifications].  Specifically, ***
16066	21 CFR 111.35(b)(1)(i)	1	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, ***
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, ***
16074	21 CFR 111.35(b)(4)	1	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, ***

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Devices

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Devices	3130	21 CFR 820.100(a)	155	Lack of or inadequate procedures	Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
	630	21 CFR 803.17	143	Lack of Written MDR Procedures	Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, ***
	3696	21 CFR 820.100(b)	131	Lack of documentation of CAPA activities	Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***
	4189	21 CFR 820.198(a)	99	General	Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].  Specifically, ***
	546	21 CFR 820.75(a)	97	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.  Specifically, ***
	14713	21 CFR 820.198(a)	85	Lack of or inadequate complaint procedures	Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,***
	479	21 CFR 820.50	84	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.  Specifically, ***
	2327	21 CFR 820.22	75	Quality audits - Lack of or inadequate procedures	Procedures for quality audits have not been [adequately] established. Specifically, ***
	3415	21 CFR 820.22	73	Quality Audit/Reaudit - conducted	Quality [audits][reaudits] have not been performed.  Specifically, ***
	3172	21 CFR 820.198(c)	71	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, ***
	3103	21 CFR 820.30(i)	65	Design changes - Lack of or Inadequate Procedures	Procedures for design change have not been [adequately] established.  Specifically,***
	2371	21 CFR 820.30(a)	64	Design control - no procedures	Procedures for design control have not been established.  Specifically,***
	731	21 CFR 803.50(a)(1)	60	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, ***
	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, ***
	447	21 CFR 820.40	54	Lack of procedures, or not maintained	Document control procedures have not been [established] [maintained].  Specifically,***
	3118	21 CFR 820.75(a)	54	Documentation - general	Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, ***
	3666	21 CFR 820.20(c)	53	Management review - Lack of or inadequate procedures	Procedures for management review have not been [adequately] established.  Specifically,***
	3125	21 CFR 820.80(d)	51	Lack of or inadequate final acceptance procedures	Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
	3282	21 CFR 820.90(a)	49	Nonconforming product,  Lack of or inadequate procedures	Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, ***
	2350	21 CFR 820.25(b)	48	Training - Lack of or inadequate procedures	Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***
	3159	21 CFR 820.184	47	DHR content - general	The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
	3160	21 CFR 820.184	45	Lack of or inadequate DHR procedures	Procedures for device history records have not been [adequately] established.  Specifically,***
	3233	21 CFR 820.72(a)	45	Calibration, Inspection, etc. Procedures Lack of or Inadequ	Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, ***
	2974	21 CFR 812.110(b)	44	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, ***
	2302	21 CFR 820.20(e)	43	Quality System Procedures	Quality system procedures and instructions have not been established.  Specifically,***
	3371	21 CFR 820.198(a)(3)	43	Processing MDRs {see also 803, 804}	Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report.  Specifically, ***
	486	21 CFR 820.50(a)	41	Evaluation of suppliers, contractors, etc., requirements	Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   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].  Specifically, ***
	3678	21 CFR 820.30(g)	41	Design Validation - Risk analysis not performed/inadequate	Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***
	3837	21 CFR 820.25(b)	40	Training documentation	Personnel training is not documented. Specifically, ***
	541	21 CFR 820.70(c)	39	Environmental control  Lack of or inadequate procedures	Procedures to control environmental conditions have not been [adequately] established.  Specifically, ***
	3104	21 CFR 820.30(j)	37	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)	33	Lack of or inadequate procedures - Acceptance activities	Procedures for acceptance activities have not been [adequately] established.  Specifically,***
	3121	21 CFR 820.80(b)	33	Receiving acceptance procedures	Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
	3291	21 CFR 820.100(b)	33	Procedures	The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
	4059	21 CFR 820.22	31	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, ***
	2968	21 CFR 812.100	30	Investigator non-compliance with agreement/plan/regulations	An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, ***
	3128	21 CFR 820.90(a)	30	Nonconforming product control	Products that do not conform to specifications are not adequately controlled. Specifically, ***
	3369	21 CFR 820.198(a)(1)	30	Uniform and timely processing	Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are processed in a uniform and timely manner.  Specifically, ***
	3680	21 CFR 820.70(a)	29	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, ***
	14505	21 CFR 812.140(a)(3)	29	Investigator's subject records inadequate	Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, ***
	537	21 CFR 820.70(a)	28	Production processes	Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, ***
	3101	21 CFR 820.30(g)	27	Design validation- Lack of or inadequate procedures	Procedures for design validation have not been [adequately] established.  Specifically,***
	3331	21 CFR 820.181	27	DMR - not or inadequately maintained	A device master record has not been [adequately] maintained.  Specifically, ***
	3690	21 CFR 820.100(a)(3)	27	Identification of actions needed	Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.  Specifically, ***
	3201	21 CFR 820.40(a)	26	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, ***
	3692	21 CFR 820.100(a)(4)	26	CAPA verification/validation of corrective/preventive action	Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.  Specifically, ***
	419	21 CFR 820.20(b)	25	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, ***
	3127	21 CFR 820.80(e)	24	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, ***
	3167	21 CFR 820.198(a)	22	Complete files maintained	Complete complaint files are not maintained.  Specifically, ***
	4191	21 CFR 806.10(a)(1)	22	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, ***
	538	21 CFR 820.70(a)	21	Process control procedures	Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented].  Specifically, ***
	2650	21 CFR 820.30(f)	21	Design verification - Lack of or inadequate procedures	Procedures for design verification have not been [adequately] established.  Specifically,***
	3192	21 CFR 820.30(g)	20	Design validation - user needs and intended uses	Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, ***
	3301	21 CFR 820.100(a)(2)	20	Investigation procedures	The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
	3665	21 CFR 820.20(b)(3)	20	Management representative	No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.  Specifically, ***
	14722	21 CFR 820.40	20	Procedures not adequately established or maintained	Document control procedures have not been adequately [established] [maintained].  Specifically,***
	631	21 CFR 803.17(a)(1)	19	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.  Specifically, ***
	3155	21 CFR 820.181(a)	19	DMR device specifications	The device master record does not include or refer to the location of  device software specifications.  Specifically, ***
	3164	21 CFR 820.184(d)	19	Acceptance records	The device history record does not include [complete] acceptance records that demonstrate the device is manufactured in accordance with the device master record.  Specifically, ***
	3286	21 CFR 820.90(b)(1)	19	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, ***
	4057	21 CFR 820.20(a)	19	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.  Specifically, ***
	3108	21 CFR 820.70(e)	18	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	18	Lack of or inadequate procedures for labeling	Procedures to control labeling activities have not been [adequately] established. Specifically, ***
3206	21 CFR 820.50(b)	18	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, ***
3235	21 CFR 820.72(a)	18	Equipment control activity documentation	Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.  Specifically, ***
3285	21 CFR 820.90(b)(2)	18	Product rework procedures, Lack of or inadequate procedures	Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, ***
3426	21 CFR 820.50(a)(1)	18	Documenting evaluation	The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***
2269	21 CFR 820.20(a)	17	Quality policy and objectives	The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility.  Specifically, ***
3299	21 CFR 820.100(a)(1)	17	Procedure for analysis of data sources	The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3687	21 CFR 820.100(a)(1)	17	Analysis of data sources	Appropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems.  Specifically, ***
2928	21 CFR 812.40	16	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, ***
3102	21 CFR 820.30(h)	16	Design transfer - Lack of or inadequate procedures	Procedures for design transfer have not been [adequately] established.  Specifically,***
3119	21 CFR 820.75(b)	16	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. Specifically, ***
3168	21 CFR 820.198(a)	16	Complaints	Complaint files are not [adequately] maintained.  Specifically ***
3250	21 CFR 820.72(b)(2)	16	Calibration documentation	There is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the next calibration date] for [inspection] [measurement] [test] equipment .  Specifically, ***
3263	21 CFR 820.250(b)	16	Sampling plans	Sampling plans are not [written][based on valid statistical rationale].  Specifically, ***
454	21 CFR 820.40(a)	15	Document review, approval by designated individual	Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, ***
6800	21 CFR 807.20	15	Establishment not registered	An establishment for which registration is required has not been registered.  Specifically, ***
2293	21 CFR 820.20(d)	14	Quality plan	A quality plan has not been [adequately] established.  Specifically, ***
2604	21 CFR 820.30(e)	14	Design review - Lack of or inadequate procedures	Procedures for design review have not been [adequately] established.  Specifically,***
3427	21 CFR 820.50(a)(2)	14	Supplier oversight	The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
14712	21 CFR 820.184	14	DHR - not or inadequately maintained	A device history record has not been [adequately] maintained.  Specifically, ***
539	21 CFR 820.70(b)	13	Production and Process Change Procedures, lack of or Inad.	Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, ***
2328	21 CFR 820.22	13	Quality audits - auditor independence	Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
2557	21 CFR 820.30(c)	13	Design input - documentation	Design input requirements were not [adequately] documented.   Specifically, ***
3226	21 CFR 820.70(g)(1)	13	Maintenance schedule, Lack of or inadequate schedule	Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, ***
3380	21 CFR 820.198(e)(6)	13	Results of investigation	Records of complaint investigations do not include the [dates] [results] of the investigation.  Specifically, ***
502	21 CFR 820.60	12	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, ***
2351	21 CFR 820.25(b)	12	Training	Employees have not been adequately trained.  Specifically, ***
3170	21 CFR 820.198(b)	12	Review and evaluation for investigation	Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
3332	21 CFR 820.184(e)	12	ID label, labeling	The device history record does not include the primary identification label and labeling for each device.  Specifically, ***
3686	21 CFR 820.90(b)(2)	12	Product rework documentation, DHR {see also 820.184}	Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, ***
3688	21 CFR 820.100(a)(1)	12	Analysis of data/reports from data sources	Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems.  Specifically, ***
632	21 CFR 803.17(a)(2)	11	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, ***
2970	21 CFR 812.100	11	Investigator lack of informed consent	Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
3284	21 CFR 820.90(a)	11	Nonconforming product evaluation/investigation	The [evaluation] [investigation] of nonconforming product has not been documented.  Specifically, ***
3288	21 CFR 820.90(b)(1)	11	Documentation of disposition, justification, signature	There is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the signature of the individual authorizing the use of nonconforming product].  Specifically, ***
3425	21 CFR 820.50(a)(1)	11	Evaluation and Selection, Suppliers, Contractors, etc.	Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.  Specifically, ***
4058	21 CFR 820.20	11	Management responsibility	Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.  Specifically, ***
4212	21 CFR 806.20(b)(4)	11	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.  Specifically,***
2630	21 CFR 820.30(e)	10	Design review documentation, DHF {see also 820.30(j)}	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, ***
2985	21 CFR 812.140(a)(3)(ii)	10	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, ***
3021	21 CFR 812.150(a)(1)	10	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, ***
3117	21 CFR 820.70(i)	10	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, ***
3157	21 CFR 820.181(c)	10	DMR QA  procedures and specifications	The device master record does not include or refer to the location of [all] quality assurance procedures and specifications.  Specifically, ***
3171	21 CFR 820.198(b)	10	Rationale documented for no investigation	Records for complaints where no investigation was made do not include required information.  Specifically ***
3231	21 CFR 820.70(i)	10	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, ***
3268	21 CFR 820.80(b)	10	Incoming inspection, testing, verification	Incoming product was not adequately inspected or tested to verify conformance to specifications.  Specifically, ***
3270	21 CFR 820.80(c)	10	Documentation	In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3303	21 CFR 820.100(a)(4)	10	Verify, validate change {see also 820.100(a)}	The procedures addressing verification or validation of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3345	21 CFR 820.200(a)	10	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, ***
3375	21 CFR 820.198(e)	10	Records of complaint investigation	Records of complaint investigations do not include required information.  Specifically, ***
3433	21 CFR 820.75(c)	10	Process changes - review, evaluation and revalidation	A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
3434	21 CFR 820.75(c)	10	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, ***
3689	21 CFR 820.100(a)(2)	10	Investigation	Certain indicators of nonconformities are not investigated to determine the cause of the nonconformity.  Specifically, ***
4070	21 CFR 820.30(g)	10	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, ***
6803	21 CFR 807.20(a)	10	Devices not listed	Devices for which listing is required have not been listed.  Specifically, ***
2430	21 CFR 820.30(b)	9	Adequacy of design and development plan	Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
3203	21 CFR 820.40(b)	9	Document change records, maintained.	Records of changes to documents were not [adequately] maintained.  Specifically, ***
3283	21 CFR 820.90(a)	9	Specific non-conforming product procedures	Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete].  Specifically, ***
3428	21 CFR 820.50(a)(3)	9	Acceptable supplier records	Records of acceptable [suppliers] [contractors] [consultants] were not maintained.  Specifically, ***
3671	21 CFR 820.25(a)	9	Personnel education, background, training & experience	Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. 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, ***
14716	21 CFR 820.30(f)	9	Design verification - output does not meet input requirement	Design verification does not confirm that design output meets design input requirements.  Specifically, ***
3123	21 CFR 820.80(c)	8	Lack of or inadequate In-process acceptance procedures	Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
3191	21 CFR 820.30(g)	8	Design validation - production units	The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***
3199	21 CFR 820.40(a)	8	Document review, approval documentation	The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, ***
3207	21 CFR 820.50(b)	8	Supplier notification of changes	There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, ***
3232	21 CFR 820.72(a)	8	Equipment suitability & capability	Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results].  Specifically, ***
3262	21 CFR 820.250(a)	8	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,***
3302	21 CFR 820.100(a)(3)	8	Identifying corrective & preventive actions	The procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3379	21 CFR 820.198(e)(5)	8	Nature and details of complaint	Records of complaint investigations do not include the nature and details of the complaint.  Specifically, ***
3677	21 CFR 820.30(g)	8	Design validation - software validation not performed	Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***
4193	21 CFR 806.10(b)	8	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, ***
812	21 CFR 803.56	7	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, ***
2429	21 CFR 820.30(b)	7	Establish the design and development plan	A design and development plan has not been [established] [defined] [documented] [implemented].  Specifically, ***
2648	21 CFR 820.30(f)	7	Design verification procedures	Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3139	21 CFR 820.140	7	Lack of or inadequate procedures for handling	Procedures for product handling have not been [adequately] established.  Specifically,***
3149	21 CFR 820.180	7	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, ***
3328	21 CFR 820.180(b)	7	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, ***
3397	21 CFR 820.80(d)(2)	7	Review of data and documentation	Finished devices were released for distribution before the associated data and documentation was reviewed.  Specifically, ***
3432	21 CFR 820.75(b)(2)	7	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, ***
7013	21 CFR 812.110(d)	7	Inadequate financial disclosure by investigator	The sponsor was not supplied [sufficient financial information to allow submission of complete and accurate certification or disclosure statements] [financial disclosure updates when a relevant change occurred during the course of the study or within one year following study completion].  Specifically, ***
14507	21 CFR 812.140(a)(3)(ii)	7	Investigator adverse effect records inadequate	Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].  Specifically, ***
2279	21 CFR 820.20(b)(2)	6	Resources	Adequate resources have not been provided for performing [management activities] [work] [assessment activities] [audits].  Specifically, ***
2981	21 CFR 812.140(a)(2)(i)	6	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, ***
2984	21 CFR 812.140(a)(3)(i)	6	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, ***
3173	21 CFR 820.198(d)	6	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, ***
3227	21 CFR 820.70(g)(1)	6	Activity documentation	Maintenance activities, including the [date] [individuals performing those activities], have not been documented.  Specifically, ***
3309	21 CFR 820.120(b)	6	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, ***
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, ***
4208	21 CFR 806.20(a)	6	Records not kept	There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,***
14720	21 CFR 820.50(a)(3)	6	Acceptable supplier records, inadequate records	Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
633	21 CFR 803.17(a)(3)	5	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, ***
2330	21 CFR 820.22	5	Quality audit corrective action, reaudits {see also 820.100}	Quality reaudits [are not adequately performed] [do not cover corrective actions for the problem areas].  Specifically, ***
2601	21 CFR 820.30(d)	5	Essential design outputs	Design outputs that are essential for the proper functioning of the device were not [completely] identified.  Specifically, ***
3111	21 CFR 820.70(f)	5	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, ***
3144	21 CFR 820.160(a)	5	Control/distribution procedures	Procedures for the control and distribution of finished devices have not been [established] [defined] [documented] [complete] [implemented] to ensure that only devices approved for release are distributed.  Specifically, ***
3162	21 CFR 820.184(b)	5	Quantity manufactured	The device history record does not include the quantity of devices manufactured.  Specifically, ***
3204	21 CFR 820.40(b)	5	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, ***
3269	21 CFR 820.80(b)	5	Incoming acceptance records, documentation	Acceptance or rejection of incoming product was not documented. Specifically, ***
3304	21 CFR 820.100(a)(5)	5	Changes to correct/prevent quality problems	Changes in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective].  Specifically, ***
3333	21 CFR 820.184(f)	5	Device identification, control numbers	The device history record does not include [certain] [any] device identifications and control numbers used.  Specifically, ***
3370	21 CFR 820.198(a)(2)	5	Oral complaints	Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all oral complaints are documented upon receipt.  Specifically, ***
3396	21 CFR 820.80(d)(1)	5	DMR required activities {see also 820.181}	Finished devices were released for distribution prior to completion of activities required in the Device Master Record.  Specifically, ***
3414	21 CFR 820.200(d)(6)	5	Test and inspection data	Service reports do not include applicable test and/or inspection data.  Specifically, ***
3416	21 CFR 820.70(a)(1)	5	Process control instructions	Process controls are not conducted in accordance with documented instructions and standard operating procedures.  Specifically, ***
3667	21 CFR 820.20(c)	5	Management review accomplishment	Management reviews do not ensure that the quality system satisfies [the requirements of part 820] [your quality policy and objectives]. Specifically, ***
3682	21 CFR 820.70(d)	5	Implementing personnel procedures - health, cleanliness, per	Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, ***
4192	21 CFR 806.10(a)(2)	5	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, ***
6802	21 CFR 807.21(a)	5	Annual registration	Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA].   Specifically, ***
7012	21 CFR 812.100	5	Investigator lack of control of investigational devices	Devices under investigation were not properly controlled.  Specifically, ***
14711	21 CFR 820.160(a)	5	Lack of or inadequate procedures for distribution	Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,***
635	21 CFR 803.17(b)(1)	4	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, ***
778	21 CFR 803.52(f)(1)	4	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, ***
2470	21 CFR 820.30(c)	4	Design input procedures - appropriateness	Procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2910	21 CFR 812.7(a)	4	Promotion or test marketing	An investigational device was [promoted] [test marketed] prior to FDA approval/clearance.  Specifically, ***
2980	21 CFR 812.140(a)(1)	4	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, ***
2991	21 CFR 812.140(b)(1)	4	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, ***
3141	21 CFR 820.150(a)	4	Storage procedures to prevent mix-ups	Procedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete] [implemented] to prevent mix-ups, damage, other adverse effects.  Specifically, ***
3142	21 CFR 820.150(a)	4	Storage procedures to avoid release of unsuitable product	Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed.  Specifically, ***
3175	21 CFR 820.186	4	QSR content	The quality system record has not been [adequately] maintained   Specifically ***
3198	21 CFR 820.40(b)	4	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, ***
3200	21 CFR 820.40(a)	4	Document locations, Dissemination, etc.	Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, ***
3224	21 CFR 820.70(g)(2)	4	Periodic equipment inspection	Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established.  Specifically, ***
3236	21 CFR 820.72(b)	4	Procedures - content	Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, ***
3266	21 CFR 820.86	4	Acceptance status	The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, ***
3310	21 CFR 820.120(b)	4	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, ***
3312	21 CFR 820.120(d)	4	Mixups	Labeling and packaging operations were not controlled to prevent labeling mix-ups.  Specifically, ***
3381	21 CFR 820.198(e)(7)	4	Corrective action taken	Records of complaint investigations do not include any corrective action taken.  Specifically, ***
3674	21 CFR 820.30(d)	4	Design output - documentation	Design output was not [adequately] documented before release.  Specifically, ***
3681	21 CFR 820.70(b)	4	Verification or validation of changes	Changes to a [specification] [method] [process] [procedure] were not verified or validated.  Specifically, ***
3693	21 CFR 820.100(a)(5)	4	Implementing changes	Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3841	21 CFR 820.90(b)(2)	4	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, ***
4060	21 CFR 820.20(b)(3)(i)	4	Management representative implementing the quality system	The management representative has not ensured that the quality system requirements are effectively established and maintained. Specifically, ***
4071	21 CFR 820.30(i)	4	Design changes - validation vs. verification	Procedures were not [established] [defined] [documented] [completed] to address when verification of design changes is sufficient in lieu of validation prior to their implementation.  Specifically, ***
7006	21 CFR 812.43(c)(5)	4	No financial disclosure info in investigator agreement	A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study].  Specifically, ***
14710	21 CFR 820.150	4	Lack of or inadequate procedures for storage.	Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,***
14718	21 CFR 820.30(g)	4	Design validation - Risk analysis	Results of the design risk analysis were not [adequately] documented.  Specifically, ***
14721	21 CFR 820.70(g)(2)	4	Periodic equipment inspections	Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented].  Specifically, ***
636	21 CFR 803.17(b)(2)	3	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, ***
738	21 CFR 803.52(a)(1)	3	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, ***
2339	21 CFR 820.22	3	Quality audit documentation	The dates of quality [audits][reaudits] have not been documented.  Specifically, ***
2403	21 CFR 820.25(a)	3	Sufficient personnel	Insufficient personnel to assure that all procedures are appropriately carried out as required by the quality system.  Specifically, ***
2431	21 CFR 820.30(b)	3	Design plans- updated	Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***
2649	21 CFR 820.30(f)	3	Design verification acceptance criteria	Acceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities.  Specifically, ***
2916	21 CFR 812.7(d)	3	Investigational device represented as safe and /or effective	An investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically, ***
2949	21 CFR 812.46(a)	3	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)	3	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, ***
2993	21 CFR 812.140(b)(2)	3	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, ***
3113	21 CFR 820.70(g)	3	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)	3	Use and removal, Lack of or inadequate procedures	Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, ***
3156	21 CFR 820.181(b)	3	DMR production process specifications	The device master record does not include or refer to the location of [all] production and process specifications.  Specifically, ***
3161	21 CFR 820.184(a)	3	DHR content - manufacturing dates	The device history record does not include manufacturing dates.  Specifically, ***
3163	21 CFR 820.184(c)	3	Quantity released	The device history record does not include the quantity of devices released for distribution.  Specifically, ***
3190	21 CFR 820.30(g)	3	Design validation acceptance criteria	Acceptance criteria were not established prior to the performance of validation activities.  Specifically, ***
3193	21 CFR 820.30(g)	3	Design validation - production units in use conditions	The design was not validated under actual or simulated use conditions.  Specifically, ***
3218	21 CFR 820.70(c)	3	Environmental control system-documentation/review inspection	Inspections of environmental control system were not [documented] [reviewed]. Specifically, ***
3241	21 CFR 820.72(b)(1)	3	Calibration standard traceability	A calibration standard used for [inspection] [measurement] [test] equipment is not traceable to national or international standards nor is it an independent reproducible standard.  Specifically, ***
3264	21 CFR 820.250(b)	3	Sampling methods - Lack of or inadequate procedures	Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,***
3290	21 CFR 820.90(b)(2)	3	Retesting and reevaluation of reworked product	Rework of nonconforming product did not include [complete] retesting and reevaluation to ensure that the reworked product met current approved specifications.  Specifically, ***
3300	21 CFR 820.100(a)(1)	3	Statistical methodology	Corrective and preventive action procedures addressing the use of appropriate statistical methodology to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3372	21 CFR 820.198(d)	3	Records of MDR Investigation	Investigation records of MDR reportable complaints do not include required information.  Specifically ***
3398	21 CFR 820.80(d)(3)	3	No release signature	Finished devices were released for distribution without signature of the individual designated to authorize such release.  Specifically, ***
3668	21 CFR 820.20(c)	3	Management review dates	The results and/or dates of management reviews are not documented. Specifically, ***
3675	21 CFR 820.30(f)	3	Design verification - unresolved discrepancies	Unresolved discrepancies were noted at the completion of the design verification.  Specifically, ***
3694	21 CFR 820.100(a)(6)	3	Dissemination of problem information	Information related to quality problems or nonconforming product is not disseminated to those directly responsible for assuring the [quality of the product] [prevention of the quality problem].  Specifically, ***
3699	21 CFR 820.160(b)	3	Distribution records	Distribution records [were not maintained] [do not include or refer to the location of required information].  Specifically, ***
3702	21 CFR 820.250(a)	3	Appropriateness	There is no information to support the appropriateness of the statistical techniques used.  Specifically, ***
3838	21 CFR 820.40(a)	3	Document review procedures, designated individual	The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, ***
4169	21 CFR 820.100(a)(7)	3	Identifying relevant info for management review	Procedures addressing identification of relevant information to be submitted for management review were not [established] [defined] [documented] [complete] [implemented].  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,***
14523	21 CFR 812.43(c)	3	No investigator agreement	A signed investigator agreement was not obtained from each participating investigator .  Specifically,***
14717	21 CFR 820.30(g)	3	Design validation - software validation documentation	Results of the validation of the device software were not [adequately] documented.  Specifically, ***
640	21 CFR 803.18(a)	2	Event files--failure to establish	MDR event files have not been established and maintained.  Specifically, ***
642	21 CFR 803.18(b)(1)(i)	2	Adverse events--all info not in file	MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.  Specifically, ***
733	21 CFR 803.50(b)(1)	2	Reporting Information Reasonably Known	An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, ***
735	21 CFR 803.50(b)(2)	2	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, ***
783	21 CFR 803.52(f)(6)	2	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, ***
2270	21 CFR 820.20(a)	2	Implement quality policy	Not all employees [know there is] [understand] [fully implement] the quality policy. Specifically, ***
2481	21 CFR 820.30(c)	2	Design input procedures - addressing conflicting requirement	Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2598	21 CFR 820.30(d)	2	Design output procedures	Procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2627	21 CFR 820.30(e)	2	Design reviews performed following schedule	Design reviews were not performed at appropriate times, following the review schedule.  Specifically, ***
2628	21 CFR 820.30(e)	2	Design review procedures - personnel	Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct responsibility for the design stage being reviewed] [any specialists needed].  Specifically, ***
2935	21 CFR 812.43(b)	2	Sponsor shipped devices to unqualified person(s)	Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation.  Specifically, ***
2972	21 CFR 812.110(a)	2	Informed consent obtained prior to study approval	Written informed consent of potential subjects to participate in an investigation was obtained prior to obtaining [IRB] [FDA] approval to conduct the investigation.  Specifically, ***
2975	21 CFR 812.110(c)	2	Investigator did not supervise use of investigational device	An investigational device was used for subjects not under the supervision of an authorized investigator.  Specifically, ***
3007	21 CFR 812.140(d)	2	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, ***
3023	21 CFR 812.150(a)(2)	2	Investigator report of IRB withdrawal of approval	A report of the withdrawal of approval by the reviewing IRB was not prepared and submitted to the sponsor [within five working days].  Specifically, ***
3025	21 CFR 812.150(a)(3)	2	No investigator progress reports	Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, ***
3027	21 CFR 812.150(a)(4)	2	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, ***
3064	21 CFR 812.140(a)(4)	2	Investigator protocol records inadequate	Copies maintained of the study protocol are not all [accurate] [complete] [current].  Specifically, ***
3109	21 CFR 820.70(d)	2	Personnel procedures-health, cleanliness, personal practices	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, ***
3151	21 CFR 820.180	2	Legibility	Required records are not legible. Specifically, ***
3195	21 CFR 820.30(g)	2	Design validation unresolved discrepancies	Unresolved discrepancies were noted at the completion of the design validation.  Specifically, ***
3237	21 CFR 820.72(b)	2	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, ***
3313	21 CFR 820.120(d)	2	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, ***
3325	21 CFR 820.180	2	Storage	Required records [are not stored so as to minimize deterioration and prevent loss] [that are stored in automated data processing systems are not backed up].  Specifically, ***
3330	21 CFR 820.181(d)	2	DMR packaging and labeling specifications	The device master record does not include or refer to the location of [packaging] [labeling] procedures and specifications.  Specifically, ***
3343	21 CFR 820.198(e)	2	Maintained	Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3346	21 CFR 820.200(b)	2	Statistical analysis {see also 820.100(a)(1)}	Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3349	21 CFR 820.200(d)	2	No documentation	Service reports were not documented. Specifically, ***
3374	21 CFR 820.198(d)(3)	2	Determination of relationship of device to event	Investigation of MDR reportable complaints did not include a determination of the relationship of the device to the reported incident or adverse event.  Specifically, ***
3376	21 CFR 820.198(e)(2)	2	Date complaint received	Records of complaint investigations do not include the date the complaint was received.  Specifically, ***
3377	21 CFR 820.198(e)(3)	2	Device identification and control number	Records of complaint investigations do not include device identifications and control numbers used.  Specifically, ***
3382	21 CFR 820.198(e)(8)	2	Reply to complainant	Records of complaint investigations do not include any reply to the complainant.  Specifically, ***
3409	21 CFR 820.200(d)	2	Service reports	Service reports [are not documented] [do not include the required information].  Specifically, ***
3417	21 CFR 820.70(a)(2)	2	Production monitoring and control	During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled.  Specifically, ***
3673	21 CFR 820.30(c)	2	Design input approval documentation	The approval of design input requirements [(including the date and signature of the individual approving the requirements)] was not documented.  Specifically, ***
3697	21 CFR 820.150(a)	2	Stock rotation, assessment before release	Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate.  Specifically, ***
4213	21 CFR 806.20(b)(5)	2	Records of communications	A copy of all communications regarding the correction or removal action was not contained in the record.  Specifically,***
4216	21 CFR 806.30	2	Access not permitted	FDA personnel were not permitted access to required records and reports for devices subject to correction and removal actions.  Specifically,***
4249	21 CFR 821.25(c)	2	Not established, maintained	Written procedures for the collection, maintenance, and auditing of device tracking information were not [established] [implemented] [complete] [provided to the FDA].  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, ***
6808	21 CFR 807.26	2	Changes	FDA was not notified within 30 days of changes in [individual ownership] [corporate structure] [partnership structure] [location] of your registered establishment.  Specifically, ***
9176	21 CFR 809.20(b)	2	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, ***
540	21 CFR 820.70(b)	1	Production and process changes - failure to follow procedure	Established procedures were not followed [completely] in making changes to [specifications] [methods] [processes] [procedures].  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, ***
650	21 CFR 803.18(e)	1	Results of evaluation not in mfr's MDR file	The results of the evaluation of each event are not documented and maintained in the manufacturer's MDR event file.  Specifically, ***
658	21 CFR 803.30(a)(2)	1	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, ***
739	21 CFR 803.52(a)(2)	1	Patient Age or Date of Birth	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's age or date of birth.  Specifically, ***
740	21 CFR 803.52(a)(3)	1	Patient Gender	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's gender.  Specifically, ***
741	21 CFR 803.52(a)(4)	1	Patient Weight	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's weight.  Specifically, ***
745	21 CFR 803.52(b)(2)	1	Death	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B that the outcome attributed to the adverse event was death.  Specifically, ***
748	21 CFR 803.52(b)(2)(iii)	1	Injury or Illness Requiring Intervention	An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B the outcome attributed to the adverse event was a serious injury or illness requiring intervention to prevent permanent impairment of a body structure or function.  Specifically, ***
749	21 CFR 803.52(b)(3)	1	Date of Event	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event.  Specifically, ***
751	21 CFR 803.52(b)(5)	1	Description of the Event or Problem	An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B a description of the event or problem to include [a discussion of how the device was involved] [the nature of the problem] [the patient follow-up or required treatment] [any environmental conditions that may have influenced the event].  Specifically, ***
791	21 CFR 803.52(f)(11)(iii)	1	Explanation of Required Information Not	An individual medical device manufacturer report submitted per FDA Form 3500A did not include in Block H an explanation of why any required information was not provided and the steps taken to obtain such information.  Specifically, ***
796	21 CFR 803.55(a)	1	Initial Submission of Baseline Report	A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model.  Specifically, ***
2276	21 CFR 820.20(b)(1)	1	Responsibility, authority and independence	Employees who manage, perform, and assess work affecting quality have not been [assigned the appropriate responsibility and authority] [provided the independence and authority] to accomplish their work. Specifically, ****
2338	21 CFR 820.22	1	Quality audit/reaudit reports	Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited.   Specifically, ***
2599	21 CFR 820.30(d)	1	Acceptance criteria and essential outputs	Design output procedures do not [contain or reference acceptance criteria] [ensure that essential design outputs are identified] [allow for an adequate evaluation of conformance to design input requirements].  Specifically, ***
2602	21 CFR 820.30(d)	1	Design output approval	Design output was not [reviewed] [approved] before release.  Specifically, ***
2913	21 CFR 812.7(b)	1	Commercialization	An investigational device was commercialized by charging the [subjects] [investigators] a price larger than that necessary to recover costs of manufacture, research, development, and handling. Specifically, ***
2920	21 CFR 812.18(b)	1	Exporter of investigational device	An investigational device was exported without obtaining FDA's approval prior to exportation and without complying with the export requirements of Section 802 of the Food, Drug, and Cosmetic Act. Specifically, ***
2924	21 CFR 812.20(a)(2)	1	Initiation of study prior to FDA IDE approval	FDA approval was not obtained prior to initiation of an investigation for which an FDA-approved IDE was required.  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, ***
2940	21 CFR 812.43(c)(4)(i)	1	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, ***
2946	21 CFR 812.45	1	Sponsor provide device information to investigators	Not all investigators participating in the investigation were supplied with copies of the [investigational plan] [report of prior investigations of the investigational device].  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, ***
2983	21 CFR 812.140(a)(2)(iii)	1	Investigator records of disposition of devices inadequate	Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
2992	21 CFR 812.140(b)(2)	1	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, ***
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, ***
3003	21 CFR 812.140(b)(6)	1	Other sponsor records required by FDA inadequate	Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, ***
3032	21 CFR 812.150(a)(5)	1	Investigator report for lack of informed consent	A report to the [sponsor] [reviewing IRB] regarding the use of an investigational device without obtaining informed consent was not submitted [within five working days after the use occurred].  Specifically, ***
3034	21 CFR 812.150(a)(6)	1	Investigator final report	A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation.  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, ***
3043	21 CFR 812.150(b)(2)	1	Sponsor notification of IRB approval withdrawal	Notification of withdrawal of approval of an investigation by a reviewing IRB was not sent [within five working days of withdrawal] to [FDA] [all reviewing IRBs] [all participating investigators].  Specifically, ***
3048	21 CFR 812.150(b)(5)	1	Sponsor progress reports for non-significant risk study	For an investigation subject to the abbreviated requirements, progress reports were not [always] submitted to all reviewing IRBs [at required intervals] [at least annually].  Specifically, ***
3049	21 CFR 812.150(b)(5)	1	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, ***
3147	21 CFR 820.170(a)	1	Installation instructions, test procedures	[Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,***
3208	21 CFR 820.50(b)	1	Approval of purchasing data {see also 820.40(a)}	The purchasing data were not approved.  Specifically, ***
3229	21 CFR 820.70(h)	1	Documentation of removal or reduction	The removal or reduction of manufacturing material has not been documented.  Specifically, ***
3230	21 CFR 820.70(i)	1	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)	1	Remedial action - documentation	Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3267	21 CFR 820.86	1	Maintained	The acceptance status of product was not clearly identified throughout [manufacturing] [packaging] [labeling] [installation] [servicing] of the product.  Specifically, ***
3271	21 CFR 820.80(d)	1	Quarantine of finished devices	Finished devices were not adequately controlled until acceptance tests were completed, results approved, and devices released.  Specifically, ***
3276	21 CFR 820.80(e)	1	Maintained as part of the DHR {see also 820.184}	Acceptance records were not maintained as part of the device history record.  Specifically, ***
3305	21 CFR 820.100(a)(6)	1	Dissemination of problem information - procedure	The corrective and preventive action procedures addressing dissemination of information on quality problems and nonconforming product to responsible individuals were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3323	21 CFR 820.170(b)	1	Installer's performance	The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.
3324	21 CFR 820.170(b)	1	Installer's documentation of results	The person installing the device did not document complete inspection and test results to demonstrate proper installation.  Specifically, ***
3355	21 CFR 820.198(f)	1	Records accessible to manufacturing site	Investigated complaints and records of investigation were not accessible to the manufacturing establishment.  Specifically, ***
3386	21 CFR 820.25(b)(2)	1	Training on verification/validation defects	Employees who perform verification and validation activities have not been made aware of defects and errors they may encounter in performing their jobs.  Specifically, ***
3402	21 CFR 820.80(e)(3)	1	Results	Acceptance records did not include the results of certain acceptance activities.  Specifically, ***
3403	21 CFR 820.80(e)(4)	1	Signature	Acceptance records did not include the signature of the individual performing the acceptance activities.  Specifically, ***
3412	21 CFR 820.200(d)(4)	1	Servicing individual	Service reports do not include the name of service person.  Specifically, ***
3413	21 CFR 820.200(d)(5)	1	Service performed	Service reports do not include what service was performed.  Specifically, ***
3420	21 CFR 820.70(a)(5)	1	Criteria for workmanship	Criteria for workmanship have not been expressed in documented standards or by means of identified and approved representative samples. Specifically, ***
3664	21 CFR 820.20(b)(2)	1	Training	Personnel are not adequately trained to perform [management activities] [work] [assessment activities] [audits]. Specifically, ***
3670	21 CFR 820.20(c)	1	Management review participants	Documentation does not show that management with executive responsibility participated in  management reviews. Specifically, ***
3684	21 CFR 820.75(a)	1	Documentation - specific items	Documentation of process validation activities and results does not include [the date and signature of the individuals approving the validation] [the major equipment validated].  Specifically, ***
3691	21 CFR 820.100(a)(4)	1	Verification vs validation	There is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation.  Specifically, ***
3698	21 CFR 820.150(b)	1	Procedures - receipt and dispatch	Procedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, ***
3701	21 CFR 820.250(a)	1	Techniques not used	Statistical techniques are not used for control purposes where statistical techniques are applicable.  Specifically, ***
3704	21 CFR 820.250(b)	1	Reviewed for adequacy	Sampling methods have not been reviewed for adequacy for their intended use.  Specifically, ***
3705	21 CFR 820.250(b)	1	Review after process change	Sampling plans were not reviewed when changes were implemented that might affect statistical sampling methods.  Specifically, ***
3706	21 CFR 820.250(b)	1	Review of sampling methods for adequacy	The review of sampling methods for adequacy for their intended use was not documented.  Specifically, ***
3839	21 CFR 820.70(a)(4)	1	Approval of process equipment	Process equipment has not been approved.  Specifically, ***
4254	21 CFR 821.30(a)	1	Failure to report	A distributor of a tracked device failed to provide required tracking information promptly.  Specifically,***
4436	21 CFR 803.40(a)	1	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, ***
6805	21 CFR 807.25(b)	1	Device activities not reported	Device activities have not been reported to FDA.  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, ***
6849	21 CFR 812.5(a)	1	Label does not contain required information	The label for an investigational device does not include [the name and place of business of manufacturer, packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device.  Limited by Federal (or United States) law to investigational use."].  Specifically, ***
6850	21 CFR 812.5(b)	1	False and misleading label statements	The labeling for an investigational device bears a statement that is [false] [misleading].  Specifically, ***
6851	21 CFR 812.5(b)	1	Labeling claims of safety and/or effectiveness	The labeling for an investigational device misrepresents that the device is [safe] [effective] for the purposes for which it is being investigated.  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, ***
9112	21 CFR 809.10(a)(5)	1	Reagent storage instructions--protect stability	A reagent [product label] [outside container] [wrapper] does not include [adequate] storage instructions [which are based on reliable, meaningful, and specific test methods] [which protect the stability of the product] .  Specifically, ***
9117	21 CFR 809.10(a)(9)(i)	1	Lot/Control Numbers - multiple unit product	Lot or control numbers on a multiple unit in vitro diagnostic [product label] [outside container] [wrapper] do not permit tracing of the identity of the individual units.  Specifically, ***
9147	21 CFR 809.10(b)(11)	1	Expected Values--range(s)	The product labeling accompanying an in vitro diagnostic product does not include [a statement of the appropriate range of expected values as obtained with the product from studies of various populations] [a description as to how the range was established] [identification of the population on which the range was established].  Specifically, ***
9673	21 CFR 809.10(c)(2)(i)	1	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)	1	Sponsor's lack of written monitoring procedures	There are no written procedures for monitoring an investigational device study.  Specifically,***
14518	21 CFR 812.35(a)(3)(iv)	1	No 5 day notification of IDE change	FDA was not notified within five working days of [developmental changes that do not constitute a significant change] [manufacturing changes that do not constitute a significant change] [changes to the clinical protocol that do not change the validity of the data or information, scientific soundness of the investigational plan, or the rights, safety, or welfare of the subjects involved].  Specifically, ***
14521	21 CFR 812.36(e)	1	No IRB approval for treatment use	A treatment use study of an investigational device did not [comply with the regulations governing informed consent] [have IRB approval].  Specifically, ***
14525	21 CFR 812.2(c)(7)	1	Needs IDE; does not meet definition of a custom device	A clinical investigation requires an IDE, as the device does not meet the definition of a custom device in that it is [generally available in finished form for purchase or dispensing upon prescription] [generally available to, or generally used by, other physicians or dentists] [not a modification of a cleared/approved device made to comply with the order of an individual physician or dentist] [offered for commercial distribution through labeling or advertisement].  Specifically, ***

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Drugs

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Drugs	1105	21 CFR 211.22(d)	165	Procedures not  in writing, fully followed	The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, ***
	1358	21 CFR 211.100(b)	115	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, ***
	2027	21 CFR 211.192	110	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, ***
	3603	21 CFR 211.160(b)	95	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, ***
	3585	21 CFR 211.110(a)	94	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, ***
	1361	21 CFR 211.100(a)	89	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, ***
	1215	21 CFR 211.67(b)	80	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, ***
	1112	21 CFR 211.25(a)	79	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, ***
	1213	21 CFR 211.67(a)	67	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)	67	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, ***
	1274	21 CFR 211.68(a)	66	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, ***
	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, ***
	1177	21 CFR 211.63	60	Equipment Design, Size and Location	Equipment used in the manufacture, processing, packing or holding of  drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].  Specifically, ***
	2419	21 CFR 211.198(a)	56	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, ***
	9001	21 CFR 211.22(a)	51	Lack of quality control unit	There is no quality control unit.  Specifically, ***
	1133	21 CFR 211.25(a)	48	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, ***
	4314	21 CFR 211.84(d)(2)	47	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, ***
	1890	21 CFR 211.165(e)	46	Test methods	The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, ***
	4352	21 CFR 211.160(b)(4)	45	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, ***
	1111	21 CFR 211.25(a)	44	Training , Education , Experience overall	Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***
	1914	21 CFR 211.166(a)	41	Lack of written stability program	There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, ***
	4391	21 CFR 211.180(e)(2)	41	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, ***
	2026	21 CFR 211.192	40	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, ***
	4402	21 CFR 211.192	40	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, ***
	1809	21 CFR 211.160(a)	39	Following/documenting laboratory controls	Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, ***
	1912	21 CFR 211.166(a)	38	Written program not followed	The written stability testing program is not followed.  Specifically, ***
	1787	21 CFR 211.80(a)	36	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, ***
	3570	21 CFR 211.100(a)	35	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, ***
	1540	21 CFR 211.125(a)	34	Strict control not exercised over labeling issued	Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, ***
	4303	21 CFR 211.67 b)	33	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, ***
	1767	21 CFR 211.137(a)	32	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, ***
	4413	21 CFR 211.194(a)(8)	32	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, ***
	4576	21 CFR 211.192	32	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, ***
	1227	21 CFR 211.67(c)	31	Cleaning/maintenance records not kept	Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, ***
	1451	21 CFR 211.113(b)	30	Procedures for sterile drug products	Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, ***
	2028	21 CFR 211.192	30	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, ***
	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, , ***
	4340	21 CFR 211.142	28	Written warehousing procedures established/followed	Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, ***
	4389	21 CFR 211.198(a)	28	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, ***
	3565	21 CFR 211.58	26	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, ***
	1194	21 CFR 211.42(c)	24	Defined areas of adequate size for operations	The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
	1943	21 CFR 211.180(e)(1)	23	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, ***
	3572	21 CFR 211.100(b)	23	Procedure Deviations Recorded and Justified	Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, ***
	3632	21 CFR 211.170(b)	23	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, ***
	1975	21 CFR 211.182	22	Written records kept in individual logs	Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, ***
	1098	21 CFR 211.22(c)	21	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, ***
	1261	21 CFR 211.68(a)	21	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, ***
	1452	21 CFR 211.113(b)	21	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, ***
	2205	21 CFR 211.186(b)(9)	21	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, ***
	3571	21 CFR 211.100(a)	21	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, ***
	1810	21 CFR 211.160(a)	20	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, ***
	4372	21 CFR 211.188(b)(8)	20	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, ***
	1550	21 CFR 211.125(f)	19	Procedures Written and Followed	Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
	1942	21 CFR 211.180(e)	19	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, ***
	2007	21 CFR 211.186(a)	19	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, ***
	3547	21 CFR 211.46(b)	18	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, ***
	4306	21 CFR 211.80(a)	18	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, ***
	1450	21 CFR 211.113(a)	17	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, ***
	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, ***
	3602	21 CFR 211.160(a)	17	Deviations from laboratory control requirements	Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, ***
	4336	21 CFR 211.150	17	Written distribution procedure	Written distribution procedures are not [established] [followed].  Specifically, ***
	4342	21 CFR 211.142(b)	17	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, ***
	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, ***
	1833	21 CFR 211.84(d)(1)	16	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, ***
1891	21 CFR 211.165(f)	16	Failing drug products not rejected	Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, ***
2619	21 CFR 211.198(b)(2)	16	Complaint Investigation/Follow-Up Findings	Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, ***
1411	21 CFR 211.105(b)	15	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)	15	Environmental Monitoring System	Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***
1790	21 CFR 211.80(b)	15	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, ***
1801	21 CFR 211.84(a)	15	Components withheld from use pending release	Each lot of [components] [drug product containers] [closures] is not withheld  from use until the lot has been sampled, tested, examined, and released by the quality control unit.  Specifically, ***
2034	21 CFR 211.194(d)	15	Laboratory equipment calibration records	Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, ***
4307	21 CFR 211.80(d)	15	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, ***
4369	21 CFR 211.188(b)(11)	15	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, ***
1885	21 CFR 211.165(b)	14	Microbiological testing	Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, ***
3561	21 CFR 211.56(b)	14	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, ***
6732	21 CFR 314.80(c)(1)(i)	14	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, ***
1448	21 CFR 211.111	13	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, ***
1926	21 CFR 211.166(b)	13	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, ***
3613	21 CFR 211.160(b)(4)	13	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, ***
4401	21 CFR 211.186(b)(9)	13	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, ***
1134	21 CFR 211.25(b)	12	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, ***
1263	21 CFR 211.68(b)	12	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, ***
1844	21 CFR 211.84(d)(2)	12	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, ***
1978	21 CFR 211.182	12	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, ***
2033	21 CFR 211.194(c)	12	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, ***
3559	21 CFR 211.56(a)	12	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, ***
3616	21 CFR 211.165(d)	12	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, ***
4338	21 CFR 211.150(b)	12	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, ***
8911	21 CFR 314.81(b)(1)(ii)	12	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, ***
1270	21 CFR 211.68(b)	11	input/output verification	Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, ***
1886	21 CFR 211.165(c)	11	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, ***
4368	21 CFR 211.188(b)(12)	11	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, ***
8907	21 CFR 314.81(b)(1)(ii)	11	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, ***
1033	21 CFR 211.22(a)	10	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, ***
1169	21 CFR 211.42(a)	10	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, ***
1920	21 CFR 211.166a)(3)	10	Valid stability test methods	The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, ***
4315	21 CFR 211.84(d)(2)	10	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)	10	Instruments, apparatus, et. al. not meeting specs	The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, ***
4357	21 CFR 211.166(a)	10	Results not used for expiration dates, storage cond.	Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, ***
1049	21 CFR 211.22(a)	9	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)	9	Inadequate number of  personnel	The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
1395	21 CFR 211.103	9	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, ***
1454	21 CFR 211.115(a)	9	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, ***
1505	21 CFR 211.122(d)	9	Label storage access limited to authorized personnel	Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, ***
1632	21 CFR 211.130(c)	9	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, ***
1802	21 CFR 211.84(b)	9	Representative Samples	Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, ***
2008	21 CFR 211.186(a)	9	Written procedures followed	Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***
2567	21 CFR 211.198(a)	9	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, ***
3582	21 CFR 211.105(a)	9	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)	9	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, ***
4373	21 CFR 211.188(b)(7)	9	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, ***
4400	21 CFR 211.186(b)(8)	9	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, ***
3557	21 CFR 211.52	8	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, ***
3614	21 CFR 211.160(b)(4)	8	Written calibration procedures	Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met].  Specifically, ***
4377	21 CFR 211.188(b(3)	8	Identification of each  component 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, ***
4406	21 CFR 211.194(a)(2)	8	Suitability of testing methods verified	The suitability of all testing methods is not verified under actual conditions of use.  Specifically, ***
1086	21 CFR 211.22(b)	7	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, ***
1495	21 CFR 211.122(a)	7	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, ***
1777	21 CFR 211.150(b)	7	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,  ***
4366	21 CFR 211.188(a)	7	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, ***
1456	21 CFR 211.115(b)	6	Reprocessing/quality control unit	Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, ***
1774	21 CFR 211.142(a)	6	Quarantine - actual practice	Drug products are not quarantined before being released by the quality control unit.  Specifically, ***
1798	21 CFR 211.82(b)	6	Quarantine Storage of Components	Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, ***
2003	21 CFR 211.184(c)	6	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 associated  batch or lot of drug product.  Specifically, ***
2035	21 CFR 211.194(e)	6	Stability testing records not  included	Laboratory records do not include complete records of all stability testing performed.  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, ***
3562	21 CFR 211.56(c)	6	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, ***
3629	21 CFR 211.170(b)	6	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, ***
4404	21 CFR 211.194(a)(1)	6	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, ***
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, ***
1162	21 CFR 211.28(a)	5	Protective Apparel Not Worn	Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, ***
1449	21 CFR 211.111	5	Deviations of production time limits	Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, ***
1498	21 CFR 211.122(b)	5	Labeling and packaging improperly approved/released	Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use].  Specifically, ***
1728	21 CFR 211.87	5	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, ***
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, ***
1851	21 CFR 211.84(e)	5	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, ***
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, ***
1917	21 CFR 211.166(a)(1)	5	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, ***
3553	21 CFR 211.48(a)	5	Plumbing System Defects	The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, ***
4320	21 CFR 211.84(d)(6)	5	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, ***
4323	21 CFR 211.115(a)	5	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, ***
4351	21 CFR 211.160(b)(3)	5	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)	5	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, ***
4409	21 CFR 211.194(a)(4)	5	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, ***
4410	21 CFR 211.194(a)(5)	5	Calculations performed are in the records	Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***
6730	21 CFR 314.80(b)	5	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, ***
1159	21 CFR 211.28(a)	4	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, ***
1266	21 CFR 211.42(d)	4	Penicillin processing area not  kept 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,  ***
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, ***
1435	21 CFR 211.42(c)(10)(v)	4	Cleaning System	Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***
1636	21 CFR 211.130(e)	4	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)	4	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, ***
1869	21 CFR 211.94(c)	4	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	4	Specific information required in individual logs	Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, ***
2012	21 CFR 211.188(b)	4	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)	4	Labeling Control Records and Label Copies	The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, ***
2203	21 CFR 211.186(b)(7)	4	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, ***
3591	21 CFR 211.110(b)	4	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, ***
3592	21 CFR 211.110(c)	4	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, ***
3639	21 CFR 211.204	4	Returned drug procedures in writing and followed	Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, ***
4304	21 CFR 211.68(b)	4	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, ***
4309	21 CFR 211.84(c)(2)	4	Containers sampled so as to prevent contamination	Containers are not [opened] [sampled] [resealed] in a manner designed to prevent contamination of [their contents] [other components] [other drug product containers or closures].  Specifically, ***
4313	21 CFR 211.84(c)(6)	4	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, ***
4325	21 CFR 211.110(a)	4	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)	4	Written procedures not followed	Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, ***
4355	21 CFR 211.165(c)	4	Sampling and testing plans not followed	Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***
4370	21 CFR 211.188(b)(10)	4	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, ***
4399	21 CFR 211.186(b)(7)	4	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, ***
4412	21 CFR 211.194(a)(7)	4	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, ***
1163	21 CFR 211.28(b)	3	Habits of good sanitation & health	Production personnel were not practicing good sanitation and health habits.  Specifically, ***
1168	21 CFR 211.34	3	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)	3	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, ***
1222	21 CFR 211.67(b)(4)	3	Cleaning SOPs/equipment identification	Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.  Specifically, ***
1256	21 CFR 211.68(b)	3	Backup file not maintained	Failure to maintain a backup file of data entered into the computer or related system.  Specifically, ***
1436	21 CFR 211.42(c)(10)(vi)	3	Equipment to control conditions	Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  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, ***
1629	21 CFR 211.130(a)	3	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, ***
1630	21 CFR 211.130(b)	3	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, ***
1633	21 CFR 211.130(d)	3	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, ***
1725	21 CFR 211.134(c)	3	Examinations documented	The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, ***
1770	21 CFR 211.137(d)	3	Expiration date location on labeling	Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations..  Specifically, ***
1843	21 CFR 211.84(d)(2)	3	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,  ***
1876	21 CFR 211.180(a), (b)	3	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, ***
1918	21 CFR 211.166(a)(2)	3	Stability sample storage conditions described	The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, ***
1957	21 CFR 211.180(e)(2)	3	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	3	Dedicated equipment: records part of batch record	The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.  Specifically, ***
2017	21 CFR 211.188(b)(5)	3	In-Process and Laboratory Control Results	The batch production and control records are deficient in that they do not  include [in-process] [laboratory] control results.  Specifically, ***
2021	21 CFR 211.188(b)(9)	3	Container/Closure Description	The batch production and control records are deficient in that they do not include a description of drug product containers and closures.  Specifically, ***
2200	21 CFR 211.186(b)(4)	3	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, ***
2402	21 CFR 211.194(a)(5)	3	Testing Calculations	Laboratory records are deficient in that they do not include all calculations performed during testing.  Specifically, ***
2618	21 CFR 211.198(b)(1)	3	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, ***
2621	21 CFR 211.198(b)(3)	3	Reason for Not Conducting Complaint Investigation	Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, ***
3594	21 CFR 211.110(d)	3	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, ***
3611	21 CFR 211.160(b)(3)	3	Acceptance of drug products	Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, ***
3615	21 CFR 211.160(b)(4)	3	Test devices not meeting specifications	Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.  Specifically, ***
3623	21 CFR 211.170(a)	3	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, ***
3641	21 CFR 211.204	3	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, ***
4302	21 CFR 211.56(b)	3	Written sanitation procedures not followed	Written procedures for sanitation are not followed.  Specifically, ***
4305	21 CFR 211.68(b)	3	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, ***
4316	21 CFR 211.84(d)(3)	3	Testing Containers & Closures Conformity with Specs	Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, ***
4317	21 CFR 211.84(d)(3)	3	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, ***
4322	21 CFR 211.101(d)	3	Component release checked by 2nd person	Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properly identified].  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, ***
4375	21 CFR 211.188(b)(5)	3	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, ***
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, ***
4380	21 CFR 211.198(b)(3)	3	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, ***
4382	21 CFR 211.198(b)(2)	3	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, ***
4388	21 CFR 211.198(a)	3	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, ***
4396	21 CFR 211.186(b)(4)	3	Variations in component amounts  not justified	The master production and control records indicate unjustified variations in the amount of components necessary for preparation of the dosage form.  Specifically, ***
4403	21 CFR 211.194(b)	3	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, ***
4407	21 CFR 211.194(a)(2)	3	Reference and method not stated	Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].  Specifically, ***
6736	21 CFR 314.80(c)(1)(ii)	3	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, ***
6833	21 CFR 314.80(c)(2)(ii)	3	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, ***
8935	FDCA 760(b)(1)	3	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, ***
1207	21 CFR 211.65(b)	2	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, ***
1224	21 CFR 211.67(b)(6)	2	Cleaning SOP/inspection	Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  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, ***
1396	21 CFR 211.42(c)(2)	2	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,***
1413	21 CFR 211.42(c)(5)	2	Mfg / Processing Operations Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  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,***
1430	21 CFR 211.42(c)(10)(i)	2	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)	2	Air Supply	Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, ***
1541	21 CFR 211.125(b)	2	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, ***
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, ***
1722	21 CFR 211.134(a)	2	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, ***
1794	21 CFR 211.80(d)	2	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, ***
1842	21 CFR 211.84(d)(1)	2	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,***
1852	21 CFR 211.94(a)	2	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, ***
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, ***
1927	21 CFR 211.166(b)	2	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, ***
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, ***
2004	21 CFR 211.184(d)	2	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, ***
2019	21 CFR 211.188(b)(7)	2	Documentation of Actual Yield and Theoretical Yield	The batch production and control records are deficient in that they do not  include a statement of the [actual yield] [percentage of theoretical yield].  Specifically, ***
2399	21 CFR 211.194(a)(2)	2	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, ***
2401	21 CFR 211.194(a)(4)	2	Complete Test Data	Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, ***
2406	21 CFR 211.194(a)(8)	2	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, ***
3445	21 CFR 211.65(a)	2	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, ***
3545	21 CFR 211.44	2	Adequate lighting not provided	Adequate lighting is not provided in all  areas.  Specifically, ***
3548	21 CFR 211.46(c)	2	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)	2	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, ***
3567	21 CFR 211.84(d)(2)	2	Component identification test	Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, ***
3569	21 CFR 211.89	2	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, ***
3631	21 CFR 211.170(b)	2	Investigation of reserve sample deterioration	Evidence of reserve drug product sample deterioration was not  [investigated] [recorded and maintained with other stability data].  Specifically, ***
4324	21 CFR 211.110(b)	2	In-process materials specifications testing	Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, ***
4343	21 CFR 211.160(b)(1)	2	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)	2	Sampling and testing procedures described	Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, ***
4345	21 CFR 211.160(b)(1)	2	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, ***
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, ***
4359	21 CFR 211.170(a)(1), (b)(1)	2	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.
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, ***
4364	21 CFR 211.176	2	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, ***
4383	21 CFR 211.198(b)(1)	2	Written complaint record must include	Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***
4385	21 CFR 211.198(b)	2	Records maintained for 1 year (except certain  OTC drugs)	Written complaint file records involving a drug product are not maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date the complaint was received, whichever is longer.  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, ***
4405	21 CFR 211.194(a)(2)	2	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, ***
4411	21 CFR 211.194(a)(6)	2	Test results, comparison with standards not included	Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested.  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, ***
6728	21 CFR 314.80(b)	2	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, ***
6830	21 CFR 314.80(c)(2)	2	Interval	Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an application which was approved less than three years ago] [yearly for an application which was approved three or more years ago].  Specifically, ***
6831	21 CFR 314.80(c)(2)	2	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)	2	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, ***
8908	21 CFR 314.81(b)(2)(i)	2	Summary	An annual report did not include [a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief description of actions the applicant has taken or intends to take as a result of this new information] [a brief description of actions the applicant has taken or intends to take as a result of new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief statement whether labeling supplements for pediatric use have been submitted and whether new studies in the pediatric population have been initiated].  Specifically, ***
8912	21 CFR 314.81(b)(2)	2	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, ***
1167	21 CFR 211.34	1	Qualifications lacking	Consultants lack sufficient education, training and experience to advise on the subject for which they are retained.  Specifically, ***
1174	21 CFR 211.42(b)	1	Product flow through building is inadequate	The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, ***
1223	21 CFR 211.67(b)(5)	1	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)	1	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, ***
1371	21 CFR 211.101(a)	1	Batches Formulated to less than 100%	Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, ***
1409	21 CFR 211.42(c)(4)	1	In-Process Material Area	Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.  Specifically, ***
1418	21 CFR 211.42(c)(7)	1	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, ***
1431	21 CFR 211.42(c)(10)(ii)	1	Temperature / Humidity Controls	Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, ***
1503	21 CFR 211.122(c)	1	Records not kept for each shipment	Records are not maintained for each shipment received of each different labeling and packaging material.  Specifically, ***
1506	21 CFR 211.122(e)	1	Destruction of obsolete labeling	Obsolete or outdated labels, labeling and packaging materials are not destroyed.  Specifically, ***
1509	21 CFR 211.122(h)	1	Printing devices	Printing devices used to imprint labeling upon the drug product [unit label] [case] are  not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
1545	21 CFR 211.125(c)	1	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, ***
1724	21 CFR 211.134(b)	1	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	1	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, ***
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, ***
1824	21 CFR 211.84(c)(5)	1	Identifying Sample Containers	Sample container identification of sampled item is deficient in that it does not include the [name of the material sampled] [lot number] [container from which the sample was taken] [date on which the sample was taken] [name of the person who collected the sample].   Specifically, ***
1825	21 CFR 211.84(c)(6)	1	Identifying Containers Sampled	Markings of containers from which samples have been taken are deficient in that they do not show that samples have been removed from them. Specifically,  ***
1846	21 CFR 211.84(d)(3)	1	Establish reliability of supplier's C of A	Establishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1849	21 CFR 211.84(d)(6)	1	Objectionable microbiological contamination	Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  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, ***
1958	21 CFR 211.180(f)	1	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, ***
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, ***
2005	21 CFR 211.184(e)	1	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)	1	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, ***
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 not  include 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, ***
2016	21 CFR 211.188(b)(4)	1	Weights and Measures of Components Used	The batch production and control records are deficient in that they do not  include [weights] [measures] of components used in the process.  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, ***
2023	21 CFR 211.188(b)(11)	1	Identification of Persons Performing Significant Steps	The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation.  Specifically, ***
2024	21 CFR 211.188(b)(12)	1	Documentation of Batch Investigations	The batch production and control records are deficient in that they do not  include documentation of batch investigations performed.  Specifically, ***
2032	21 CFR 211.194(b)	1	Test method modification records not maintained	Complete records are not maintained of any modification of an established method employed in testing.  Specifically, ***
2089	21 CFR 211.208	1	No records maintained	No records are maintained for salvaged drug products.  Specifically, ***
2397	21 CFR 211.194(a)(1)	1	Description and Identification of Samples	Laboratory records are deficient in that they do not include a [description and identification of the sample received] [quantity] [lot number] [date sample taken] [date sample received for testing].  Specifically, ***
2420	21 CFR 211.198(a)	1	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, ***
2569	21 CFR 211.198(b)	1	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, ***
3554	21 CFR 211.48(a)	1	Potable water standards not met	The potable water being permitted for use in the potable water system fails to meet  standards prescribed by the Environmental Protection Agency.  Specifically, ***
3555	21 CFR 211.48(b)	1	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, ***
3556	21 CFR 211.50	1	Sewage and refuse disposal in safe manner	Disposal of  [sewage] [trash] [refuse] from the [building] [immediate premises] is not done  in a safe and sanitary manner.  Specifically, ***
3558	21 CFR 211.52	1	Washing and toilet facilities not provided and accessible	Washing and toilet facilities are not [provided] [easily accessible to working areas].  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, ***
3581	21 CFR 211.101(d)	1	Verification of component addition	Each component is not added to the batch by one person and verified by a second person..  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, ***
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, ***
3609	21 CFR 211.160(b)(2)	1	In-process sample representation/identification	In-process samples are not [representative] [properly identified]. 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, ***
3630	21 CFR 211.170(b)	1	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, ***
3633	21 CFR 211.170(b)(1)	1	Reserve sample retention time	The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3)) is deficient in that they are not retained for one year after the expiration date of the drug product.  Specifically, ***
3640	21 CFR 211.204	1	Returned drug products identified and held	Returned drug products are not [identified as such] [held].  Specifically, ***
4308	21 CFR 211.94(d)	1	Written Procedures to Remove Pyrogens Not Followed	Written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilizing] [methods of processing] to remove pyrogenic properties of drug product containers and closures are not followed.  Specifically, ***
4312	21 CFR 211.84(c)(5)	1	Sample Containers Identification	Sample containers were not identified in a manner which allows determination of  [name of the material sampled] [lot number] [container from which the sample was taken] [name of person who collected the sample].  Specifically, ***.
4318	21 CFR 211.84(d)(4)	1	Microscopic Exam of Components	Components are not microscopically examined when appropriate.  Specifically, ***
4319	21 CFR 211.84(d)(5)	1	Exam for Filth, Insects, Extraneous Adulterants	Each lot of  [components] [drug product containers] [closures] that is liable to contamination with filth, insect infestation or other extraneous adulterants is not examined against established specifications for such contamination.  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, ***
4330	21 CFR 211.130(e)	1	Packaging line inspection documentation	Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, ***
4354	21 CFR 211.165(d)	1	Acceptance/Rejection Levels	The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, ***
4356	21 CFR 211.166(b)	1	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, ***
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, ***
4374	21 CFR 211.188(b)(6)	1	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, ***
4386	21 CFR 211.198(b)	1	Written complaint record  to be maintained at facility	A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or packed provided the written records are readily available for inspection at that other facility].  Specifically, ***
4392	21 CFR 211.186(b)(1)	1	Name, strength, dosage form	The master production and control records do not include [the name and strength of the product] [a description of the dosage form].  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, ***
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, ***
4417	21 CFR 211.204	1	Associated batches implicated, investigated	No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products.   Specifically, ***
6704	21 CFR 310.305(c)	1	Submission of report to incorrect office	Postmarketing 15-day Alert reports have been submitted to FDA, but not to FDA's Division of Pharmacovigilance and Epidemiology.  Specifically, ***
6823	21 CFR 314.80(c)	1	Failure by applicant to report ADE	Adverse drug experience information has not been reported to FDA.  Specifically, ***
6825	21 CFR 314.80(c)(1)(iii)	1	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, ***
6829	21 CFR 314.80(c)(2)	1	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, ***
6840	21 CFR 314.80(f)(1)	1	Wrong form - domestic ADE	An FDA Form 3500A has not been completed for each report of a domestic adverse drug experience.  Specifically, ***
6841	21 CFR 314.80(f)(1)	1	Wrong form - foreign ADE	An FDA Form 3500A or CIOMS I form has not been completed for each report of a foreign adverse drug experience.  Specifically, ***
8906	21 CFR 314.81(b)(1)(i)	1	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, ***
8910	21 CFR 314.81(b)(2)(iii)	1	Labeling information	An annual report did not include [currently used professional labeling] [patient brochures or package inserts] [a representative sample of the package labels] [a summary of any changes in labeling that have been made since the last report, listed by date in the order in which they were implemented, or if no changes, a statement of that fact].   Specifically, ***
8913	21 CFR 314.81(b)(2)(iv)(a)	1	Reports re: chemical, physical, or other properties	An annual report did not include reports of [experiences] [investigations] [studies] [tests] involving [chemical or physical properties] [properties of the drug] which, as new information, might affect FDA's previous conclusions about the safety or effectiveness of the drug.   Specifically, ***
8917	21 CFR 314.81(b)(2)(vi)(b)	1	Completed, unpublished clinical trials	An annual report did not include [summaries] [prepublication manuscripts] of completed, unpublished clinical trials conducted by, or otherwise obtained by, the applicant.   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, ***
10022	21 CFR 310.305(a)	1	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, ***

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Bioresearch monitoring

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Bioresearch monitoring	7560	21 CFR 312.60	153	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)	87	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, ***
	7526	21 CFR 312.62(a)	46	Accountability records	Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].  Specifically, ***
	7281	21 CFR 56.108(a)(1)	45	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)	40	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, ***
	7227	21 CFR 50.27(a)	32	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, ***
	7334	21 CFR 56.115(a)(5)	22	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, ***
	7498	21 CFR 312.66	22	Unanticipated problems	Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, ***
	7562	21 CFR 312.60	21	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***
	7482	21 CFR 312.50	19	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, ***
	7290	21 CFR 56.108(c)	17	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, ***
	7321	21 CFR 56.110(c)	17	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, ***
	7552	21 CFR 312.66	16	Changes in research	Not all changes in research activity were approved by an Institutional Review Board prior to implementation.  Specifically, ***
	7335	21 CFR 56.115(a)(6)	14	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, ***
	7391	21 CFR 50.25(a)(5)	12	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, ***
	7520	21 CFR 312.64(b)	12	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, ***
	7231	21 CFR 50.20	11	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, ***
	7278	21 CFR 56.107(e)	11	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, ***
	7342	21 CFR 56.108(b)(2)	11	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, ***
	7286	21 CFR 56.108(b)(1)	10	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, ***
	7654	21 CFR 56.110(b)	10	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, ***
	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, ***
	7343	21 CFR 56.108(b)(3)	9	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, ***
	7392	21 CFR 50.25(a)(7)	9	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, ***
	7411	21 CFR 312.53(c)(1)	9	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, ***
	7480	21 CFR 312.50	8	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, ***
	7517	21 CFR 312.66	7	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, ***
	3923	21 CFR 58.33(f)	6	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, ***
	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, ***
	7368	21 CFR 56.108(a)2)	6	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)	6	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, ***
	7209	21 CFR 50.25(a)(1)	5	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, ***
	7277	21 CFR 56.107(d)	5	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, ***
	7316	21 CFR 56.115(a)(4)	5	Copies of IRB/CI correspondence	Copies have not been maintained of all correspondence between the IRB and the investigators.  Specifically, ***
	7317	21 CFR 56.115(a)(1)	5	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, ***
	7459	21 CFR 312.57(a)	5	Records of receipt, shipment, disposition	Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug.  Specifically, ***
	3932	21 CFR 58.35(b)(6)	4	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, ***
	3958	21 CFR 58.81(a)	4	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, ***
	4025	21 CFR 58.185(a)(9)	4	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, ***
	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, ***
	7333	21 CFR 56.104(c)	4	Emergency use and IRB approval	A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal.  Specifically, ***
	7369	21 CFR 56.109(h)	4	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, ***
	7390	21 CFR 50.25(a)(4)	4	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, ***
	7527	21 CFR 312.62(a)	4	Unused drug disposition (investigator)	Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].  Specifically, ***
	7666	21 CFR 50.20	4	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, ***
	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, ***
	3920	21 CFR 58.33(c)	3	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, ***
	3926	21 CFR 58.35(b)(1)	3	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, ***
	3954	21 CFR 58.63(a)	3	Equipment: calibration	Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized.  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, ***
	3989	21 CFR 58.107	3	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, ***
	4006	21 CFR 58.120(b)	3	Protocol: approval of changes	Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated, and maintained with the protocol.  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, ***
	7320	21 CFR 56.109(e)	3	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)	3	Retention of records	Records required by 21 CFR 56 have not been maintained for three years following completion of the research.  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).  Specifically, ***
	7340	21 CFR 56.108(a)(3)	3	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)	3	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, ***
	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, ***
	7393	21 CFR 50.25(a)(8)	3	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, ***
	7507	21 CFR 312.52(a)	3	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, ***
	7543	21 CFR 312.61	3	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, ***
	7657	21 CFR 50.25(b)(5)	3	Significant new findings	The informed consent document did not include a statement that significant new findings developed during the course of the research, which might relate to the subject's willingness to continue participation, would be provided to the subject.  Specifically, ***
	7664	21 CFR 50.20	3	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, ***
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, ***
3911	21 CFR 58.31(c)	2	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, ***
3919	21 CFR 58.33(b)	2	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, ***
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, ***
3933	21 CFR 58.35(b)(7)	2	QAU: signed statement in final report	The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director.  Specifically, ***
3952	21 CFR 58.61	2	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, ***
3957	21 CFR 58.81(a)	2	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, ***
3959	21 CFR 58.81(a)	2	SOPs: authorized changes	Not all significant changes in established standard operating procedures were properly authorized in writing by management.  Specifically, ***
4016	21 CFR 58.185(a)	2	Final report: non-existent	A final report was not prepared for each nonclinical laboratory study.  Specifically, ***
4021	21 CFR 58.185(a)(5)	2	Final report: stability of test and control articles	The final study report did not include the stability of the test and control articles under the conditions of administration.  Specifically, ***
7274	21 CFR 56.107(a)	2	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, ***
7279	21 CFR 56.107(f)	2	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)	2	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, ***:
7353	21 CFR 50.52	2	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, ***
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, ***
7384	21 CFR 50.25(b)(1)	2	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)	2	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, ***
7396	21 CFR 50.24(a)(3)	2	Prospect of direct benefit not determined	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that participation in the research held out the prospect of direct benefit to the subjects because [they faced a life-threatening situation requiring intervention] [evidence from preclinical studies supported the potential for intervention to provide a direct benefit to subjects] [associated risks were reasonable under the circumstances].  Specifically,***
7399	21 CFR 50.24(a)(7)	2	Additional protections of rights and welfare	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that additional protections of the rights and welfare of the subjects would be provided, including [consultation with, and public disclosure to, the communities in which the clinical investigation would be conducted, and from which the subjects would be drawn] [establishment of an independent data monitoring committee to exercise oversight of the clinical investigation] [attempting to contact (within the therapeutic window, when obtaining informed consent was not feasible and a legally authorized representative was not reasonably available) the subject's family member who was not a legally authorized representative, and asking whether he or she objected to the subject's participation in the clinical investigation].  Specifically,***
7406	21 CFR 56.109(a)	2	Scope of reviews	The IRB does not review all research activities covered by the regulations.  Specifically, ***
7452	21 CFR 312.56(c)	2	IND safety report	Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report.  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, ***
7479	21 CFR 312.56(a)	2	Monitoring investigations	Failure to monitor the progress of an investigation conducted under your IND.  Specifically, ***
7488	21 CFR 312.59	2	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, ***
7531	21 CFR 312.62(c)	2	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, ***
7545	21 CFR 312.120(c)	2	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, ***
7629	21 CFR 312.56(c)	2	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, ***
7652	21 CFR 56.113	2	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, ***
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, ***
7660	21 CFR 50.24(a)(1)	2	IRB failed to find/document required conditions	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that [the human subjects were in a life-threatening situation] [available treatments were unproven or unsatisfactory] [the collection of valid scientific evidence was necessary to determine the safety and effectiveness of particular interventions].  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, ***
3902	21 CFR 58.29(a)	1	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, ***
3913	21 CFR 58.31(e)	1	Management: availability of resources	Testing facility management failed to assure that all personnel, resources, facilities, equipment, materials, and methodologies were available as scheduled.  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, ***
3925	21 CFR 58.35(a)	1	QAU: separate and independent	The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study.  Specifically, ***
3931	21 CFR 58.35(b)(5)	1	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, ***
3935	21 CFR 58.35(d)	1	QAU: access to SOPs, certify inspections	The quality assurance unit failed to provide access to the testing facility's written procedures for inspection of nonclinical laboratory studies.  Specifically, ***
3945	21 CFR 58.45	1	Facility: perishable supplies	The testing facility does not provide appropriate storage areas for preservation of perishable supplies.  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, ***
3955	21 CFR 58.63(b)	1	Equipment: maintenance SOPs	The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate.  Specifically, ***
3976	21 CFR 58.90(f)	1	Animal care: cage and equipment cleaning	Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals.  Specifically, ***
3977	21 CFR 58.90(g)	1	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, ***
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, ***
3988	21 CFR 58.105(d)	1	Test article: reserve sample retention	Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks' duration were retained for the required period of time.  Specifically, ***
3996	21 CFR 58.120(a)(3)	1	Protocol: sponsor name and address	Not all protocols contained the name of the sponsor and the name and address of the testing facility at which the study is being conducted.  Specifically, ***
4008	21 CFR 58.130(b)	1	Conduct: test systems monitoring	Not all test systems were monitored in conformity with the protocol.  Specifically, ***
4009	21 CFR 58.130(c)	1	Conduct: identification of test specimens	Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data.  Specifically, ***
4011	21 CFR 58.130(e)	1	Conduct: recording in ink	Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink.  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, ***
4013	21 CFR 58.130(e)	1	Conduct: changes not obscuring original entries	Not all changes in entries were made so as not to obscure the original entry, indicated the reason for such change, and were dated and signed or identified at the time of the change.  Specifically, ***
4018	21 CFR 58.185(a)(2)	1	Final report: objectives, procedures, changes	The final study report did not include the objectives and procedures stated in the approved protocol, including any changes in the original protocol.  Specifically, ***
4024	21 CFR 58.185(a)(8)	1	Final report: dosage, regimen, route of admin., duration	The final study report did not include a description of the dosage, dosage regimen, route of administration, and duration.  Specifically, ***
4026	21 CFR 58.185(a)(10)	1	Final report: names of those involved	The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study.  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.  Specifically, ***
4035	21 CFR 58.190(a)	1	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, ***
4039	21 CFR 58.190(c)	1	Archives: individual responsible	An individual was not identified as responsible for the archives.  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, ***
4045	21 CFR 58.195(e)	1	Archives: retention of summaries of training, et. al.	Not all required summaries of training and experience and job descriptions were retained for the required period of time.  Specifically, ***
4047	21 CFR 58.195(g)	1	Archives: records not retained as originals, true copies	Not all required records were retained as original records or as true copies of the original records.  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, ***
7270	21 CFR 56.103(a)	1	IRB review requirement	A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review].  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, ***
7292	21 CFR 56.109(g)	1	Providing publicly-disclosed information to sponsor	The IRB has not [promptly] provided to the sponsor of research involving an exception to informed consent a copy of information that has been publicly disclosed by regulation.  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, ***
7322	21 CFR 56.111 (a)(2)	1	Risks to subjects reasonable	The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result.  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, ***
7328	21 CFR 56.111(b)	1	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, ***
7336	21 CFR 56.115(a)(7)	1	Statements of significant new findings	Documentation has not been [prepared] [maintained] of all statements of significant new findings provided to subjects, as required by 21 CFR 50.25.  Specifically, ***
7354	21 CFR 50.53	1	Factors required for approval	The IRB approved a study in which more than minimal risk to children was presented by [an intervention or procedure that did not hold out the prospect of direct benefit for the subjects] [a monitoring procedure that was not likely to contribute to the well-being of the subjects].  However, the IRB did not [find] [document] that [the risk represented a minor increase over minimal risk] [the intervention or procedure presented experiences to subjects that were reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations] [the intervention or procedure was likely to yield generalizable knowledge about the subjects' disorder or condition that was of vital importance for the understanding or amelioration of the subjects' disorder or condition] [adequate provisions had been made for soliciting the assent of the children and permission of their parents or guardians].  Specifically, ***
7374	21 CFR 56.109(c)(2)	1	Exception from informed consent; emergency research	The IRB waived the requirement for a written consent form signed by the [subject] [subject's legally authorized representative], without first determining that the requirements in 21 CFR 50.24 for an exception from informed consent for emergency research were met.  Specifically, ***
7389	21 CFR 50.25(a)(3)	1	Benefits to the subject	A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document.  Specifically, ***
7394	21 CFR 50.24(a)(2)	1	No determination that obtaining IC wasn't feasible	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that obtaining informed consent was not feasible.  Specifically,***
7397	21 CFR 50.24(a)(5)	1	Not contacting reps within potential therapeutic window	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that the proposed investigational plan defined the length of the potential therapeutic window based on scientific evidence, and the investigator had committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative for consent within that window rather than proceeding without consent.  Specifically,***
7398	21 CFR 50.24(a)(6)	1	No determination that IC procedure/document were approved	In approving an investigation without requiring informed consent, the IRB did not [find] [document] that appropriate informed consent procedures and an informed consent document consistent with 21 CFR 50.25 were in place for use [with subjects or their legally authorized representatives in situations where use of such procedures and documents was feasible] [when providing an opportunity for a family member to object to a subject's participation in the clinical investigation].  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, ***
7428	21 CFR 312.53(c)(2)	1	Investigator CV or other statement of qualifications	Failure to obtain a curriculum vitae or other statement of the qualifications of the investigator, before permitting an investigator to participate in an investigation.  Specifically, ***
7518	21 CFR 312.64(d)	1	Financial info	Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor.  Specifically, ***
7519	21 CFR 312.64(c)	1	Final study report	An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.   Specifically, ***
7534	21 CFR 312.68	1	FDA access to clinical investigator records	Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports.  Specifically, ***
7555	21 CFR 312.53(d)	1	Selecting monitors	Monitors not qualified by experience and training were selected to monitor the progress of a clinical investigation.   Specifically, ***
7557	21 CFR 312.56(b)	1	Notification of FDA of termination of investigator	Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.  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***
7631	21 CFR 312.53(c)(4)	1	Financial information - commitment to update	Failure to obtain from an investigator a commitment to update financial information, to allow complete and accurate certification or disclosure statements.   Specifically, ***
7638	21 CFR 312.20(a)	1	Failure to submit an IND	The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***
7679	21 CFR 56.106(a)	1	IRB for CI's in support of research/marketing permits	An individual authorized to act on behalf of an IRB which reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products has not submitted registration information.  Specifically, ***

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Veterinary medicine

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Veterinary medicine	4185	FDCA 402(a)(4)	155	Record keeping	Treatment records were not [maintained] [complete].  Specifically,***
	4093	21 CFR 530.11(d)	98	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)	98	Drug inventory	You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock].  Specifically, ***
	4182	FDCA 501(a)(5)	48	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, ***
	1360	FDCA 501(a)(5)	33	Expired drugs	Expired drug(s) were observed in the drug storage area.  Specifically, ***
	4097	21 CFR 530.20(a)(2)(iv)	31	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, ***
	13509	FDCA 402(a)(4)	28	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, ***
	4298	21 CFR 530.11(a)	26	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, ***
	13521	21 CFR 530.41(a)	25	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, ***
	1442	FDCA 402(a)(4)	22	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, ***
	4186	FDCA 402(a)(4)	22	System for administration of drugs	Failure to have a system to control administration of drug treatments to your animals.  Specifically, ***
	1389	21 CFR 530.11(a)	18	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, ***
	13508	FDCA 402(a)(4)	14	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, ***
	4184	FDCA 501(a)(5)	13	Conditions of use	Administration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, ***
	1362	21 CFR 530.11(a)	11	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, ***
	1366	21 CFR 530.11(a)	10	Dosage level	Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
	1446	FDCA 402(a)(4)	9	Hospital pen	Failure to [identify] [segregate] [quarantine] treated animals.  Specifically, ***
	4545	21 CFR 225.120	9	Vermin and pest infestation	Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation.  Specifically, ***
	1811	21 CFR 225.58(b)(1)	8	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, ***
	4560	21 CFR 225.165	8	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, ***
	1457	FDCA 402(a)(4)	7	Feeding colostrum	Feeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, ***
	1373	21 CFR 530.11(a)	6	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, ***
	1469	21 CFR 225.20(b)(3)	6	Pest access minimized	The building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  Specifically, ***
	4099	21 CFR 530.20(a)(2)(ii)	6	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, ***
	1850	21 CFR 225.58(d)	5	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,***
	2075	21 CFR 225.102(b)(1)	5	Preparation of MRF	A  Master Record File providing the complete procedure for manufacturing a specific product  is not [prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***
	4098	21 CFR 530.20(a)(2)(i)	5	Diagnosis and evaluation of conditions	Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or animal drug was to be used in a food-producing animal, contrary to the drug's labeling.  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, ***
	1491	21 CFR 225.30(b)(2)	4	Maintenance reasonably clean & orderly	Equipment is not  maintained in a reasonably clean and orderly manner.  Specifically, ***
	1760	21 CFR 225.42(b)(6)	4	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, ***
	2097	21 CFR 225.102(b)(4)	4	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, ***
	4113	21 CFR 530.12(e)	4	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, ***
	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, ***
	13534	21 CFR 511.1(b)(7)(ii)	4	Records: Maintenance	Complete records of the investigation were not maintained.  Specifically, ***
	1262	21 CFR 225.10(b)(2)	3	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, ***
	1376	21 CFR 530.11(a)	3	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, ***
	1466	21 CFR 225.20(b)(2)	3	Maintained in clean and orderly condition	Buildings are not maintained in a reasonably clean and orderly manner.  Specifically, ***
	1493	21 CFR 225.30(b)(4)	3	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, ***
	1744	21 CFR 225.42(b)(6)	3	Daily inventory record kept	Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.  Specifically, ***
	4131	21 CFR 589.2000(c)(1)(i)	3	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, ***
	4132	21 CFR 589.2000(d)(1)	3	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, ***
	4137	21 CFR 589.2000(d)(1)	3	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, ***
	4183	FDCA 501(a)(5)	3	Frequency of administration	Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].  Specifically, ***
	4553	21 CFR 225.142	3	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, ***
	13541	FDCA 501(a)(5)	3	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, ***
	1575	21 CFR 225.42(b)(4)	2	Integrity and identity	Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity.  Specifically, ***
	1638	21 CFR 225.42(b)(5)	2	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, ***
	1765	21 CFR 225.42(b)(6)(i) - (v)	2	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, ***
	1782	21 CFR 225.42(b)(7)	2	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, ***
	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, ***
	1923	21 CFR 225.65(b)	2	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, ***
	1952	21 CFR 225.80(b)(2)	2	Proofreading labels, labeling, placards	Incoming  [labels] [labeling] [placards] are not proofread upon receipt from the printer against the Master Record Files  to verify suitability and accuracy.  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, ***
	2076	21 CFR 225.102(b)(1)	2	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, ***
	2093	21 CFR 225.102(b)(2)(i)-(iv)	2	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, ***
	4094	21 CFR 530.11(b)	2	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, ***
	4108	21 CFR 530.12(a)	2	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, ***
	4112	21 CFR 530.12(d)	2	Cautionary statements	Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
	4541	21 CFR 225.42(b)	2	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, ***
	4547	21 CFR 225.130	2	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, ***
	4555	21 CFR 225.142	2	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, ***
	4567	21 CFR 225.202	2	Facilitation of recall	The [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  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, ***
	1465	21 CFR 225.20(b)(1)	1	Building grounds maintenance	The building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass] [improperly stored equipment].  Specifically, ***
1482	21 CFR 225.30(b)(1)	1	Capability to produce a medicated feed	Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity].  Specifically, ***
1535	21 CFR 225.42(b)(2)	1	Storage of packaged drugs	Packaged drugs are not stored  in their original closed containers.  Specifically, ***
1539	21 CFR 225.42(b)(3)	1	Identification and storage of bulk drugs	Bulk drugs are not [identified] [stored] in a manner such that their identity, strength, quality, and purity will be maintained.  Specifically, ***
1634	21 CFR 225.42(b)(5)	1	Receipt for each lot of drug received	Failure to [prepare] [maintain] a receipt record for each lot of drug received.  Specifically, ***
1880	21 CFR 225.58(e)	1	Distribution discontinued	Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued.  Specifically, ***
1882	21 CFR 225.58(e)	1	Subsequent production	Following distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feed  was resumed prior to the establishment of proper control procedures.  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, ***
2074	21 CFR 225.102(a)	1	Lack of MRF	Failure to have a  Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product.  Specifically, ***
2091	21 CFR 225.102(b)(2)	1	Preparation of Production Records	The production record  is not prepared by qualified personnel for each batch or run of medicated feed. Specifically, ***
2232	21 CFR 225.115(b)(1)	1	Maintaining records of complaints	The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is not maintained on the premises.  Specifically, ***
2233	21 CFR 225.115(b)(1)	1	Records of oral or written complaints	The record of each oral or written complaint relating to the safety and effectiveness of a  medicated feed  fails to include the [date of the complaint] [complainant's name] [complainant's address] [name and lot or control number or date of manufacture] [specific details of the complaint] [correspondence from the complainant and/or memoranda of conversations] [description of all investigations made by the manufacturer] [method of disposition of the complaint]. Specifically, ***
2352	21 CFR 226.58(a)	1	Specifications, test procedures - components	Laboratory controls do not include adequate specifications and test procedures to assure that drug components used in the manufacture of Type A medicated articles conform to appropriate specifications.  Specifically, ***
2359	21 CFR 226.58(e)	1	Test method reliability	Laboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures. Specifically, ***
4100	21 CFR 530.20(a)(2)(iii)	1	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, ***
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, ***
4115	21 CFR 530.13(a)	1	From bulk drugs	Compounding an animal drug from a bulk drug.  Specifically, ***
4118	21 CFR 530.13(b)(3)	1	Outside of scope of professional practice	Compounding  of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the scope of a professional practice.  Specifically, ***
4119	21 CFR 530.13(b)(4)	1	Inadequate procedures and processes	Failure to follow adequate procedures and processes to ensure the safety and effectiveness of a compounded animal drug.  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, ***
4147	21 CFR 589.2000(e)(1)	1	Written product separation procedures	Failure to maintain procedures for separating products which may contain protein derived from mammalian tissues from all other protein products, from the time of receipt until the time of shipment.  Specifically, ***
4166	21 CFR 226.102(a)(5)	1	Master formula records do not have...	Master-formula records for Type A medicated articles do not include [control instructions] [procedures] [specifications] [special notations] [precautions] to be followed.  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, ***
4544	21 CFR 225.120	1	Buildings--space and access	Buildings for the production of medicated feed lack adequate space for [equipment] [processing] [orderly receipt and storage of medicated feed] [access to equipment for routine maintenance and cleaning].  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, ***
4554	21 CFR 225.142	1	Bulk Type A and Type B storage	Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality and purity will be maintained.  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, ***
4569	21 CFR 225.202	1	Records kept one year	Records identifying the formulation, date of mixing, and date of shipment (if not for own use) are not retained on the premises for one year following the date of last distribution.  Specifically, ***
13524	21 CFR 511.1(b)(8)(iv)	1	Medical claims	Representations were made that the new animal drug under investigation is [safe][effective].  Specifically, ***
13526	21 CFR 511.1(b)(8)(ii)	1	Sponsor/CRO: Reporting of hazards	The [sponsor][CRO] failed to promptly investigate and report to the FDA and investigators any  findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the drug.  Specifically, ***
13528	21 CFR 511.1(b)(8)(ii)	1	Sponsor: Monitoring	The [sponsor][CRO] did not provide for current monitoring of the investigation by a qualified person.  Specifically, ***
13531	21 CFR 511.1(b)(7)(iii)	1	Reports: Adequate and Timely	The investigator did not furnish adequate and timely reports of the investigation to the sponsor.  Specifically, ***
13535	21 CFR 511.1(b)(7)(i)	1	Sponsor/CRO: education, training, experience	The [sponsor][CRO] did not assure that the new animal drug was shipped only to investigators who have the scientific training and/or experience to evaluate the safety and/or effectiveness of the drug.   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, ***
13567	21 CFR 589.2001(c)(2)(iv)	1	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,***
13568	21 CFR 589.2001(c)(2)(v)	1	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,***

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Biologics

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Biologics	76	21 CFR 606.100(b)	135	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)	51	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,***
	155	21 CFR 606.160(b)	33	Required records	Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  Specifically, ***
	9225	21 CFR 606.171	31	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, ***
	160	21 CFR 606.160(a)(1)	30	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, ***
	31	21 CFR 606.20(b)	28	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, ***
	154	21 CFR 606.160(a)(1)	26	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, ***
	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, ***
	4425	21 CFR 606.60(a)	16	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, ***
	78	21 CFR 606.100(c)	14	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, ***
	159	21 CFR 606.160(a)(1)	14	Legibility and indelibility	Records are [illegible] [not indelible].  Specifically, ***
	12202	21 CFR 606.170(a)	14	Adverse Reaction - Investigations	A thorough investigation of each reported adverse reaction was not made.  Specifically,
	15030	21 CFR 606.60(b)	12	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, ***
	57	21 CFR 606.60(a)	11	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, ***
	208	21 CFR 640.3(a)(1)	10	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, ***
	158	21 CFR 606.160(e)	8	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, ***
	9044	21 CFR 600.10(b)	8	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, ***
	9243	21 CFR 630.6(a)	8	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, ***
	41	21 CFR 606.40(a)(1)	7	Provide space for examination	Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors.  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 reagents  Specifically, ***
	224	21 CFR 640.4(f)	7	Arm preparation	The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.  Specifically, ***
	9220	21 CFR 606.100(b)(20)	7	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, ***
	12203	21 CFR 606.170(a)	7	Adverse Reaction- Reports of Investigations	Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.  Specifically,
	61	21 CFR 606.60(a)	5	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, ***
	77	21 CFR 606.100(b)	5	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)	5	Donor criteria	The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria.  Specifically, ***
	94	21 CFR 606.100(b)(15)	5	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, ***
	161	21 CFR 606.160(a)(2)	5	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, ***
	9089	21 CFR 600.14(c)	5	When to report	Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.  Specifically, ***
	9596	21 CFR 640.3(a)	5	Donor suitability by means of medical history	Failure to [always] determine donor suitability on the day of collection by means of [medical history] [test for hemoglobin level] [physical examination].  Specifically, ***
	35	21 CFR 606.40	4	Clean & orderly	Failure to maintain facilities in a clean and orderly manner.  Specifically, ***
	93	21 CFR 606.100(b)(14)	4	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, ***
	246	21 CFR 640.25(a)	4	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, ***
	9234	21 CFR 630.6(c)	4	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, ***
	9238	21 CFR 630.6(b)(3)	4	Results of testing	Failure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral] [supplemental tests].   Specifically, ***
	63	21 CFR 606.65	3	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)	3	SOP compliance	Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.  Specifically, ***
	88	21 CFR 606.100(b)(9)	3	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, ***
	117	21 CFR 606.121(f)	3	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, ***
	142	21 CFR 606.140(a)	3	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, ***
	150	21 CFR 606.151(e)	3	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, ***
	157	21 CFR 606.160(d)	3	Retention period	Failure to retain records [for 5 years after the  records 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, ***
	162	21 CFR 606.165(a)	3	Distribution and receipt - recalls	Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall.  Specifically, ***
	165	21 CFR 606.170(a)	3	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, ***
	205	21 CFR 640.3(f)	3	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, ***
	212	21 CFR 640.3(b)(3)	3	Qualifications of donor - hemoglobin	Each  donor was not in good health as indicated in part by the blood hemoglobin level which was demonstrated to be less than 12.5 gm. of hemoglobin per 100 ml of blood (38% by microhematocrit).  Specifically, ***
	225	21 CFR 640.4(f)	3	Closed system	The blood is [not collected by aseptic methods in a sterile system] [collected using a vented system which fails to protect the blood against contamination].  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, ***
	251	21 CFR 640.25(b)	3	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, ***
	333	21 CFR 640.64(e)	3	Prevention of contamination	The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood.  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, ***
	9219	21 CFR 606.100(b)(20)	3	Donor deferral	The standard operating procedure fails to include a written description of the donor deferral process.  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, ***
	9241	21 CFR 630.6(a)	3	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, ***
	9271	21 CFR 610.41	3	Donor Deferral - reentry	The method or process used to requalify deferred donors was not found acceptable for such purposes by FDA.  Specifically, ***
	42	21 CFR 606.40(a)(2)	2	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, ***
	50	21 CFR 606.40(c)	2	Provide adequate handwashing	Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel.  Specifically, ***
	51	21 CFR 606.40(c)	2	Provide adequate toilet facilities	Failure to provide [adequate] [clean] [convenient] toilet facilities for donors and personnel.   Specifically, ***
	54	21 CFR 606.40(d)(2)	2	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, ***
	86	21 CFR 606.100(b)(7)	2	Methods for performance of all tests	The standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood components during processing.  Specifically, ***
	156	21 CFR 606.160(c)	2	Assignment of donor number	Failure of records describing the history and ultimate disposition of blood products to include a donor number [assigned to each accepted donor] [which relates to the unit of blood collected from that donor] [which relates to the donor's medical record] [which relates to any component or blood product from the donor's unit of blood].  Specifically, ***
	167	21 CFR 606.170(b)	2	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, ***
	215	21 CFR 640.3(b)(6)	2	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, ***
236	21 CFR 640.5(e)	2	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, ***
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, ***
3244	21 CFR 640.61	2	Written consent	Failure to obtain written consent of prospective Source Plasma donors.  Specifically, ***
9052	21 CFR 600.11(b)	2	Equipment	There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use].  Specifically, ***
9078	21 CFR 600.12(a)	2	Maintenance  - tracing	Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced.  Specifically, ***
9227	21 CFR 606.171(a)	2	BPDR - procedures	Failure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor.  Specifically, ***
9235	21 CFR 630.6(c)	2	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, ***
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, ***
45	21 CFR 606.40(a)(5)	1	Provide space for storage of finished product	Failure to provide adequate space for the storage of finished products prior to distribution.  Specifically, ***
46	21 CFR 606.40(a)(6)	1	Provide space for quarantine of unsuitable for use items	Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use.  Specifically, ***
49	21 CFR 606.40(a)(9)	1	Provide space for all packaging, labeling, & finishing ops.	Failure to provide adequate space for the orderly conduction of all [packaging] [labeling] [other finishing] operations.  Specifically, ***
64	21 CFR 606.65(b)	1	Visual examination	Failure to inspect each blood collecting container [and its satellite container(s)] for damage or evidence of contamination including breakage of seals and abnormal discoloration [prior to its use] [immediately after filling].  Specifically, ***
81	21 CFR 606.100(b)(2)	1	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, ***
84	21 CFR 606.100(b)(5)	1	Accurate measurement of quantity of blood	The standard operating procedure fails to include a written description of the blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood removed from the donor.  Specifically, ***
105	21 CFR 606.122	1	Instruction circular - required information	Failure to provide an instruction circular for products intended for transfusion containing adequate directions for use and the information contained in 21 CFR 606.122.  Specifically, ***
121	21 CFR 606.121(c)(2)	1	Name, address, registration number	The container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed product].  Specifically, ***
137	21 CFR 606.121(c)(13)	1	Unapproved encoded/machine readable information	The container label bears encoded information in the form of machine-readable symbols which have not been approved for use by the Director, Center for Biologics Evaluation and Research).  Specifically, ***
143	21 CFR 606.140(b)	1	Provisions to monitor lab test procedures & instruments	Failure to establish  adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments.  Specifically, ***
147	21 CFR 606.151(d)	1	Crossmatching of donor/recipient cells	Failure of standard operating procedures for compatibility testing to include the testing of the donor’s cells with the recipient’s serum (minor crossmatch) by a method that will demonstrate agglutinating, coating and hemolytic antibodies.  Specifically, ***
164	21 CFR 606.165(c)	1	Receipt records - content	Receipt records fail to contain the [name and address of the collecting facility] [date received] [donor or lot number assigned by the collecting facility] [date of expiration or the date of collection, whichever is applicable]  Specifically, ***
198	21 CFR 640.2(c)(3)	1	Blood not stored between 1-6 deg / shipped 1-10 deg	Reissued blood has not been [stored continuously at 1 to 6 C] [shipped between 1 and 10 C].  Specifically, ***
203	21 CFR 640.3(d)	1	Therapeutic bleedings	Blood is used as a source of Whole Blood which was withdrawn in order to promote the health of a donor otherwise qualified and the container label failed to conspicuously indicate the donor's disease that necessitated withdrawal of blood.  Specifically, ***
233	21 CFR 640.5(b)	1	Testing - ABO	Failure to test blood for determination of ABO blood group [using two blood group tests] [using appropriate reagents] [using appropriate techniques].  Specifically, ***
247	21 CFR 640.24(b)	1	Storage until removal of platelets	Failure to hold [whole blood] [plasma] immediately after collection between 20 and 24 degrees Celsius until the platelets are separated.  Specifically, ***
253	21 CFR 640.25(b)(4)	1	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, ***
270	21 CFR 640.34(b)	1	Fresh Frozen Plasma - preparation	Failure to prepare Fresh Frozen Plasma [from blood collected by a single uninterrupted venipuncture]  [separated from the red blood cells, placed in a freezer within the appropriate time frame, and stored at - 18 degrees Celsius or colder].  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, ***
325	21 CFR 640.63(c)(10)	1	Narcotics use	Each donor was not in good health on the day of donation, as indicated in part by [arms] [forearms] with [skin punctures] [scars] indicative of addiction to self-injected narcotics.  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, ***
343	21 CFR 640.65(b)(3)	1	Donor identification system	Failure to establish a donor identification system that positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.  Specifically, ***
369	21 CFR 640.72(a)(1)	1	Shipping temperature requirements	Failure to maintain documentation establishing that the shipping temperature requirements are being met for Source Plasma intended for manufacture into injectable products.  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, ***
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, ***
3618	21 CFR 606.100(b)(19)	1	Procedure for HIV lookback	There is no written procedure to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to human immunodeficiency virus, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations.  Specifically, ***
9005	21 CFR 606.100(b)(19)	1	Notification of consignees re: antibody test results	The written procedures for HIV "lookback" fail to include notification of consignees for Whole Blood, blood components, Source Plasma, and Source Leukocytes of the results of antibody testing of a donor of blood who has tested repeatedly reactive for antibody to human immunodeficiency virus, or otherwise has been determined to be unsuitable when tested in accordance with the applicable regulations.  Specifically, ***
9051	21 CFR 600.11(a)	1	Work areas - temperatures	The [refrigerators] [incubators] [temperature controlled rooms] [are not maintained at the required temperatures] [are not free of extraneous material that may affect the safety of the product].  Specifically, ***
9076	21 CFR 600.12(a)	1	Maintenance  - concurrence	Records are not made [concurrently with the performance] of each step in the [manufacture] [distribution] of products.  Specifically, ***
9077	21 CFR 600.12(a)	1	Maintenance - completeness	The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product].  Specifically, ***
9080	21 CFR 600.12(b)(2)	1	Retention - Records of Recall	Recall records for distributed product [were] [are] not [generated] [retained] [complete].  Specifically, ***
9092	21 CFR 600.80(b)	1	Review of Adverse Experiences - follow up information	Failure to submit all follow up information on adverse experience reports to FDA, as required.  Specifically, ***
9107	21 CFR 600.11(h)	1	Sterile & pyrogen free	There is no assurance that [final containers] [closures] for products intended for use by injection are [sterile] [pyrogen free].  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, ***
9237	21 CFR 630.6(b)(2)	1	Type of donations	Failure to notify the donor of the types of donations of blood or blood components that the donor should not donate in the future.  Specifically, ***
9240	21 CFR 630.6(d)(1)	1	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, ***
9242	21 CFR 630.6(d)(2)	1	Notification	Failure to [make] [document] reasonable attempts to notify the autologous donor's referring physician within 8 weeks after determining that the autologous donor is deferred.  Specifically, ***
9256	21 CFR 610.41	1	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, ***
10009	n/a	1	Conditions of probation	Deviation from conditions of probation.  Specifically, ***

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Parts 1240 and 1250

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Parts 1240 and 1250	7036	21 CFR 1250.67	76	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)	38	Contamination	Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils].  Specifically, ***
	7032	21 CFR 1250.63	36	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, ***
	6552	21 CFR 1250.28	22	Handling to avoid contamination	Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination.  Specifically, ***
	6558	21 CFR 1250.30(d)	18	Plumbing design, installation, maintenance	Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils].  Specifically, ***
	6570	21 CFR 1250.33(c)	14	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, ***
	6569	21 CFR 1250.33(b)	11	Equipment kept clean	Failure to keep all equipment clean.  Specifically, ***
	6564	21 CFR 1250.33(a)	10	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, ***
	7053	21 CFR 1250.75(b)	10	Sanitary sewers or alternative methods	Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].  Specifically, ***
	6555	21 CFR 1250.30(a)	9	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, ***
	6572	21 CFR 1250.34	9	Thermometers	Failure to equip each refrigerator with a thermometer located in the warmest region thereof.  Specifically, ***
	6581	21 CFR 1250.38(b)	9	Soap, sanitary towels, water	Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water].  Specifically, ***
	6591	21 CFR 1250.42(a)	8	Backflow protection	A water system not protected against backflow.  Specifically, ***
	6593	21 CFR 1250.42(b)	6	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, ***
	7055	21 CFR 1250.75(b)	6	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, ***
	7090	21 CFR 1250.82(e)	6	Backflow prevention - general	Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment].  Specifically, ***
	6567	21 CFR 1250.33(b)	5	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)	5	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, ***
	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, ***
	6549	21 CFR 1250.27	4	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, ***
	6584	21 CFR 1250.39	3	Containers - watertight, readily cleanable, non-absorbent	Garbage containers are not [watertight] [readily cleanable] [non-absorbent].  Specifically, ***
	6585	21 CFR 1250.39	3	Containers - close-fitting covers	Garbage containers lack close-fitting covers.  Specifically, ***
	7041	21 CFR 1250.70(a)	3	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)	2	Clean hands	Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment].  Specifically, ***
	6565	21 CFR 1250.33(a)	2	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, ***
	6579	21 CFR 1250.38(a)	2	Suitable design and construction	Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees.  Specifically, ***
	6609	21 CFR 1250.49	2	Clean and free of flies and mosquitoes	Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit.  Specifically, ***
	7038	21 CFR 1250.67	2	Signs for non-potable water	Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking.  Specifically, ***
	7042	21 CFR 1250.70(a)	2	Clean and sanitary	Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition.  Specifically, ***
	7089	21 CFR 1250.82(d)	2	Identification marks on tanks and piping	Not all [tanks] [piping] bear clear marks of identification.  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, ***
	6554	21 CFR 1250.30(a)	1	Ventilation and lighting	Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated].  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, ***
	6568	21 CFR 1250.33(b)	1	Cleaning of all other utensils	Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the day's operation.  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, ***
	6612	21 CFR 1250.50	1	Designed to permit ready cleaning	Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning.  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, ***
	7056	21 CFR 1250.75(c)	1	Persons handling soil cans and other containers	Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected with the [loading] [unloading] [transporting] [handling] of [food] [water] [ice].  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, ***
	7111	21 CFR 1250.87	1	Cross connections	Systems for wash water do not meet the requirements of a potable water system, and the distribution system is cross-connected to a system carrying water of lower sanitary quality.  Specifically, ***

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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)	34	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)	26	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, ***
	12416	21 CFR 1271.260(e)	15	Storage temperatures recorded, maintained	Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, ***
	12230	21 CFR 1271.50(a)	11	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, ***
	12310	21 CFR 1271.160(a)	11	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, ***
	12213	21 CFR 1271.47(a)	10	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, ***
	12247	21 CFR 1271.55(d)(2)	10	Accurate, indelible, legible	Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, ***
	12277	21 CFR 1271.75(a)(1)	9	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, ***
	12326	21 CFR 1271.160(c)	9	Quality audits performed periodically	Periodic quality audits of activities related to core CGTP requirements have not been performed.  Specifically, ***
	12431	21 CFR 1271.265(e)	9	Procedures and release criteria	Procedures including  release criteria for activities relating to  the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
	12229	21 CFR 1271.50(a)	8	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, ***
	12309	21 CFR 1271.160(a)	8	Program is appropriate for the HCT/Ps	A quality program appropriate for the  HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
	12334	21 CFR 1271.170(c)	8	Trained or re-trained as necessary	Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities.  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, ***
	12223	21 CFR 1271.47(b)	7	Review and approval of procedures	Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
	12286	21 CFR 1271.80(b)	7	Specimen collections not  timely	Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, ***
	12237	21 CFR 1271.55(a)(3)	6	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, ***
	12301	21 CFR 1271.150(c)(1)(iii)	6	Ensurane of compliance	You did not ensure that establishment(s) that  by 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, ***
	12369	21 CFR 1271.200(b)	6	Procedures inadequate	Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, ***
	12417	21 CFR 1271.260(e)	6	Periodic review of temperatures	Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.  Specifically, ***
	12433	21 CFR 1271.265(f)	6	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, ***
	12239	21 CFR 1271.55(b)(2)	5	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, ***
	12283	21 CFR 1271.75(e)	5	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, ***
	12332	21 CFR 1271.170(b)	5	Qualifications lacking	Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.  Specifically, ***
	12414	21 CFR 1271.260(d)	5	Corrective actions	Corrective actions were not [performed] [documented] when proper storage conditions were not met.  Specifically, ***
	12429	21 CFR 1271.265(d)	5	Shipping conditions appropriate	Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.  Specifically, ***
	12444	21 CFR 1271.270(e)	5	Contract firms--identities and responsibilities	The [name and address] [list of responsibilities] of establishment(s) that perform manufacturing steps for you [was not maintained] [was not made available to FDA during an inspection].  Specifically, ***
	12492	21 CFR 1271.85(a)	5	Infection with communicable disease agents	Donors were not tested for evidence of infection with communicable disease agents.  Specifically, ***
	12493	21 CFR 1271.90(b)	5	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, ***
	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, ***
	12231	21 CFR 1271.50(b)(1)	4	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, ***
	12311	21 CFR 1271.160(b)(1)	4	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, ***
	12312	21 CFR 1271.160(b)(2)	4	Procedures for complaints and other information	The quality program has not ensured that procedures exist for [receiving] [investigating] [evaluating] [documenting] information relating to core CGTP requirements, including complaints.
	12338	21 CFR 1271.180(b)	4	Review and approval-responsible person	Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
	12421	21 CFR 1271.265(a)	4	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, ***
	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, ***
	12496	21 CFR 1271.85(b)(2)	4	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. ***
	12238	21 CFR 1271.55(b)(1)	3	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, ***
	12242	21 CFR 1271.55(c)	3	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, ***
	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, ***
	12314	21 CFR 217.160(b)(2)(iii)	3	Risk assessment, quarantine, recall, FDA	The quality program has not ensured that procedures include provisions for [assessing the risk of] [quarantine of] [recall of] [reporting to FDA on] HCT/Ps that have been made available for distribution and for which there is information related to the possible contamination or communicable disease transmission.  Specifically, ***
	12322	21 CFR 1271.160(b)(4)	3	Training of personnel	The quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, ***
	12323	21 CFR 1271.160(b)(5)	3	Monitoring systems	The quality program has not established and maintained appropriate monitoring systems.  Specifically, ***
	12324	21 CFR 1271.160(b)(6)	3	Deviations--Investigation, documenting, trending	The quality program does not include [the investigation] [the documentation] [the trending] [the reporting] of HCT/P deviations relating to core CTGP requirements.  Specifically, ***
	12325	21 CFR 1271.160(b)(6)	3	Deviations--evaluation, cause, corrective action	Investigation of deviations related to core  CGTP 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, ***
	12339	21 CFR 1271.180(c)	3	Availability of procedures	Procedures for core CTGP requirements were not available to personnel  in the area where operations are performed, or in a nearby area when such availability is impractical.  Specifically, ***
	12365	21 CFR 1271.195(d)	3	Documentation not maintained	Documentation of environmental control and monitoring activities was not maintained.  Specifically, ***
	12372	21 CFR 1271.200(c)	3	Calibrated per established schedules	Equipment used for [inspection] [measuring] [testing] was not calibrated  according to established schedules.  Specifically, ***
	12375	21 CFR 1271.210(a)	3	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, ***
	12395	21 CFR 1271.225	3	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)	3	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, ***
	12399	21 CFR 1271.230(a)	3	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, ***
	12411	21 CFR 1271.260(a)	3	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, ***
	12437	21 CFR 1271.270(a)	3	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, ***
	3744	21 CFR 1270.33(a)	2	Accurate, indelible, legible	Failure to maintain records which are [accurate] [indelible] [legible].  Specifically, ***
	12222	21 CFR 1271.47(a)	2	Design of procedures to ensure compliance	Procedures were not designed to ensure compliance with the donor eligibility requirements.  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, ***
	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, ***
	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, ***
	12272	21 CFR 1271.65(b)(2)	2	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)	2	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, ***
	12282	21 CFR 1271.75(d)	2	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, ***
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, ***
12288	21 CFR 1271.80(c)	2	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)	2	Reactive tests--not determined ineligible	Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.  Specifically, ***
12319	21 CFR 1271.160(b)(3)	2	Actions taken and documented	The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented].  Specifically, ***
12328	21 CFR 1271.160(d)	2	Validation for intended use	The performance of [custom computer software] [commercial computer software that has been customized or programmed], including changes to computer software, has not been validated for the intended use, when such software is relied upon to comply with core GTP requirements.  Specifically, ***
12337	21 CFR 1271.180(a)	2	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, ***
12359	21 CFR 1271.195(a)(3)	2	Aseptic processing---cleaning, disinfecting	Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing.  Specifically, ***
12364	21 CFR 1271.195(c)	2	Monitoring-microorganisms where appropriate	Environmental conditions were not monitored for microorganisms.  Specifically, ***
12368	21 CFR 1271.200(a)	2	Capable of valid results	Equipment used for [inspection] [measuring] [testing] was not capable of producing valid results.  Specifically, ***
12370	21 CFR 1271,200(c)	2	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, ***
12412	21 CFR 1271.260(b)	2	Storage temperatures appropriate	HCT/Ps were not stored at appropriate temperatures.  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, ***
12447	21 CFR 1271.290(b)	2	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, ****
12460	21 CFR 1271.320(c)	2	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, ***
12472	21 CFR 1271.350(b)(1)	2	Deviations not investigated	HCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated.  Specifically, ***
12473	21 CFR 1271.350(b)(2)	2	Deviations not reported to FDA	HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an establishment under contract, agreement, or arrangement with your establishment] were not reported to FDA.  Specifically, ***
15024	21 CFR 1271.320(b)	2	Available for review and copying by FDA	The complaint file was not made available for review and copying upon request from FDA.  Specifically, ***
3745	21 CFR 1270.33(a)	1	Person involved, dates, details	Records fail to [identify the person performing the work] [include the dates of the various entries] [be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved].  Specifically, ***
3758	21 CFR 1270.35(c)	1	Receipt and/or distribution	Records fail to include documentation of receipt and/or distribution of human tissue.  Specifically, ***
12232	21 CFR 1271.50(b)(2)	1	Donor testing not negative for CD agents	Donor testing of HCT/P donors considered eligible was not negative  or nonreactive for relevant communicable disease agents.  Specifically, ***
12234	21 CFR 1271.55(a)(1)	1	Identification code affixed to container	After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a distinct identification code affixed to the HCT/P container.  Specifically, ***
12235	21 CFR 1271.55(a)(1)	1	Personal information included in I.D. code	The distinct identification code affixed to the HCT/P container included an individual's [name] [social security number] [medical record number].  Specifically, ***
12243	21 CFR 1271.55(d)(1)	1	Documentation maintained (general)	Documentation was not maintained after the donor-eligibility determination was complete.  Specifically, ***
12257	21 CFR 1271.60(c)(2)	1	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, ***
12258	21 CFR 1271.60(c)(3)	1	Statement of restrictions	HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the product must not be implanted, transplanted, infused or transferred until completion of the donor-eligibility determination.  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, ***
12291	21 CFR 1271.80(d)(2)	1	Plasma diluted test specimens	Donors were not determined to be ineligible whose communicable disease test specimens were plasma diluted, and [the donor was not tested using a specimen which was taken before transfusion or infusion and within seven days before recovery of the cells or tissue] [an appropriate algorithm was not used to determine that the plasma dilution did not affect the test results].  Specifically, ***
12315	21 CFR 1271.160(b)(2)	1	Sharing of information (general)	The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or communicable disease transmission of HCT/Ps.  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, ***
12333	21 CFR 1271.170(b)	1	Not qualified, authorized for functions	Personnel perform functions for which they are not [qualified] [authorized].  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, ***
12343	21 CFR 1271.190(a)	1	State of repair	Facilities were not maintained in a good state of repair.  Specifically, ***
12344	21 CFR 1271.190(a)	1	Lighting, ventilation, plumbing	Facilities did not provide adequate [lighting] [ventilation] [plumbing] [drainage] [access to sinks and toilets] to prevent the introduction, transmission or spread of communicable disease.  Specifically, ***
12351	21 CFR 1271.190(d)(1)	1	Procedures for cleaning, sanitation	Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, ***
12356	21 CFR 1271.195(a)	1	Adequate control, proper conditions	Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for operations were not provided].  Specifically, ***
12362	21 CFR 1271.195(b)	1	Corrective actions	Appropriate corrective actions were not taken related to the inspections of environmental control systems.  Specifically, ***
12371	21 CFR 1271.200(a)	1	Cleaned, sanitized per established schedules	Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]  according 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, ***
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, ***
12387	21 CFR 1271.220(a)	1	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, ***
12396	21 CFR 1271.225	1	Approval and timely communication	Process changes were [not approved by a responsible person with appropriate knowledge and background prior to implementation] [not communicated to personnel in a timely manner].  Specifically, ***
12405	21 CFR 1271.250(a)	1	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, ***
12408	21 CFR 1271.250(c)	1	All labeling requirements met	Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements.  Specifically, ***
12409	21 CFR 1271.250(c)	1	Documentation of donor eligibility	Labeling procedures did not ensure that HCT/Ps made available for distribution are accompanied by documentation of the donor eligibility determination.  Specifically, ***
12415	21 CFR 1271.260(e)	1	Temperature limits	Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents.  Specifically, ***
12423	21 CFR 1271.265(b)	1	Shipment in quarantine of HCT/Ps	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 shipped in quarantine.  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, ***
12427	21 CFR 1271.265(c)(3)	1	HCT/Ps made under departure from process	A responsible person did not determine that HCT/Ps manufactured under a departure from procedures do not increase the risk of communicable disease prior to making the HCT/Ps available for distribution.  Specifically, ***
12428	21 CFR 1271.265(c)(3)	1	Departures:  recorded and justified	Departures from procedures were not [recorded] [justified] at the time of occurrence.  Specifically, ***
12440	21 CFR 1271.270(b)	1	Prompt retrieval from multiple locations	The records management system was not designed to ensure that records stored in more than one location can be promptly identified and retrieved.  Specifically, ***
12443	21 CFR 1271.270(d)	1	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, ***
12458	21 CFR 1271.320(b)	1	Designated complaint file	Complaints received were not maintained in a file designated for complaints.  Specifically, ***
12470	21 CFR 1271.350(a)(2)	1	15 day reporting timeframe	Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information.  Specifically, ***
12475	21 CFR 1271.370(a)	1	Clear and accurate label	HCT/Ps made available for distribution were not labeled [clearly] [accurately].  Specifically, ***
12476	21 CFR 1271.370(b)(1)	1	Identification code affixed	HCT/Ps made available for distribution were not labeled with a distinct identification code affixed to the HCT/P container.  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, ***
15019	21 CFR 1271.160(d)	1	Computer software verification	The performance of computer software has not been verified.  Specifically, ***
15022	21 CFR 1271.200(e)	1	Documentation of use	Records of the use of each piece of equipment, and the HCT/Ps manufactured with the equipment, were not maintained.  Specifically, ***

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Radiological health

Center Name	Cite Id	Ref No	Frequency	Short Description	Long Description
Radiological health	5007	21 CFR 1002.13	7	Failure to submit	You did not submit an annual report [by the September 1 deadline] for products requiring one.  Specifically, ***
	5034	21 CFR 1010.2(c)	7	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, ***
	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, ***
	5194	21 CFR 1040.10(g)(9)	3	Label locations	All labels affixed to a laser product were not affixed so as to make unnecessary during reading, human exposure to laser radiation in excess of the accessible emission limits of Class I radiation or the limits of collateral radiation established in table VI of 21 CFR 1040.10(d). Specifically, ***
	5005	21 CFR 1002.11	2	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, ***
	5044	21 CFR 1010.3(a)(2)	2	ID label lacks place, month & year of manufacture	An identification label fails to provide the [place] [month] [year] of manufacture.  Specifically, ***
	5144	21 CFR 1040.10(f)(2)(i)	2	Safety interlock not provided	Each laser product was not provided with at least one safety interlock for each portion of the protective housing which is designed to be removed or displaced during operation or maintenance, when such removal or displacement permitted human access to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI.  Specifically, ***
	5443	21 CFR 1020.30(g)	2	Providing adequate assembly information	Instructions for [assembly] [installation] [adjustment] [testing] of components adequate to assure that the product will comply with the regulations, when [assembled] [installed] [adjusted]  [tested] as directed, was not provided to [assemblers] [persons other than assemblers, upon request, at a cost not to exceed the cost of publication and distribution]  Specifically, ***
	5006	21 CFR 1002.12	1	Not submitted prior to introduction	You did not submit an abbreviated report, required by 21 CFR 1002.1, prior to introduction of the product.  Specifically, ***
	5032	21 CFR 1010.2(b)	1	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, ***
	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, ***
	5048	21 CFR 1010.4(d)	1	Variances - Improper certification	Failure to modify the [tag] [label] [certification] of a product for which a variance has been granted to state [that the product conforms to the applicable standard, except with respect to those characteristics covered by the variance] [that the product conforms with the provisions of the variance] [the assigned number and effective date of the variance].  Specifically ***
	5122	21 CFR 1030.10(c)(3)(iii)	1	Measurements with tap water container	Microwave oven measurements were not made with the microwave oven [operating at maximum output] [containing a load of  275 ± 15 milliliters of  tap water initially at 20 ± 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer].  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, ***
	5147	21 CFR 1040.10(f)(2)(iii)(b)	1	No multiple safety interlocks for Class II emission limits	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 laser radiation in excess of the accessible emission limits of Class II to be emitted directly through the opening created in the protective housing.  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, ***
	5155	21 CFR 1040.10(f)(5)(iii)	1	Emission indicator pre 8/20/86	Both laser and laser energy source fail to incorporate an emission indicator, when the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters (laser systems manufactured on or before August 20, 1986). 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, ***
	5185	21 CFR 1040.10(g)(7)(i)	1	DIPH label wording - Class II	Labels regarding Class II accessible laser radiation which [are visible on the product prior to and during interlock defeat]  [are in close proximity to the opening created by the removal or displacement of such portion of the protective housing] [include the wording: "CAUTION --- Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM."] were not provided for defeatably interlocked protective housings. Specifically, ***
	5195	21 CFR 1040.10(g)(10)	1	Labels legible, visible, permanent	Labels which are legible and clearly visible during operation, maintenance, or service are not permanently affixed to or inscribed on laser products.  Specifically, ***
	5200	21 CFR 1040.10(h)(1)(iv)	1	User info - list controls, etc.	The manufacturer did not provide or cause to be provided  a 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, ***
	5203	21 CFR 1040.10(h)(2)(i)	1	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, ***
	5213	21 CFR 1040.11(c)	1	Demonstration laser products	Each demonstration laser product  [does not comply with all of the applicable requirements for a Class I, IIa, II, or IIIa  laser product] [prevent human access to laser radiation in excess of the accessible emission limits of Class I, IIa, II or IIIa].  Specifically, ***
	5479	21 CFR 1020.30(n)	1	Compliance measurement	Compliance with the aluminum equivalence limits was not determined by x-ray measurements made [at a potential of 100 kilovolts peak] [with an x-ray beam that has a half-value layer of 2.7 millimeters of aluminum].  Specifically, ***
	5690	21 CFR 1002.10(g)	1	Methods and procedures in testing radiation safety	A product report did not describe the methods and procedures employed in testing and measuring each model with respect to electronic product radiation safety, including [the control of unnecessary, secondary, or leakage electronic product radiation] [the applicable quality control procedures used for each model] [the basis for selecting testing and quality control procedures].  Specifically, ***
	5705	21 CFR 1002.31(a)	1	Five year requirement	You have not preserved your required record(s) for a period of five years from the date of the record.  Specifically, ***
	5769	21 CFR 1020.33(c)(2)(i)(a)	1	CTDI along the axis of rotation of the phantom	The computed tomography dose index (CTDI) is not provided to users for locations along the axis of rotation of the dosimetry phantom.   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, ***
	5802	21 CFR 1002.13	1	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, ***
	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, ***

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