Inspections, Compliance, Enforcement, and Criminal Investigations

FY 2014 Inspectional Observation Summaries

Number of 483s Issued from the System*

Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM

 
Center Name 483s Issued
Foods 2476
Devices 972
Drugs 645
Veterinary Medicine 337
Bioresearch Monitoring 297
Biologics 146
Human Tissue for Transplantation 115
Parts 1240 and 1250 70
Radiological Health 16
Sum Product Area 483s from System* 5074
Actual Total in System 483s** 4943
 
 

*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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Cite Id Reference Number Short Description Long Description Frequency
1560 21 CFR 110.35(c) 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, *** 332
1524 21 CFR 123.11(b) 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, *** 311
1306 21 CFR 110.20(b)(7) Screening Failure to provide adequate screening or other protection against pests. Specifically, *** 218
1422 21 CFR 110.20(b)(4) 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, *** 208
961 21 CFR 123.6(c)(3) 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, 200
905 21 CFR 123.6(b) HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, *** 194
959 21 CFR 123.6(c)(1) Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, *** 191
960 21 CFR 123.6(c)(2) 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, *** 174
963 21 CFR 123.6(c)(5) 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*** 157
1695 21 CFR 110.80(b)(2) Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination]. Specifically, *** 153
6004 21 CFR 123.6(c)(4) Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically*** 143
1552 21 CFR 110.35(a) Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, *** 142
904 21 CFR 123.6(b) 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, *** 139
1689 21 CFR 110.80 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, *** 133
1525 21 CFR 123.11(c) 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, *** 125
1287 21 CFR 110.20(a)(1) 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, *** 120
1597 21 CFR 110.37(b)(3) As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, *** 120
1701 21 CFR 110.80(b)(7) 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, *** 120
1554 21 CFR 110.35(a) 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, *** 118
908 21 CFR 123.6(d) Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, *** 116
1553 21 CFR 110.35(a) Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, *** 115
2386 21 CFR 110.80(a)(1) Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, *** 114
1427 21 CFR 110.20(b)(5) Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, *** 113
1424 21 CFR 110.20(b)(4) 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, *** 112
6008 21 CFR 123.8(a)(3) 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, *** 111
945 21 CFR 123.12(a)(2) 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, *** 106
1581 21 CFR 110.37(e) Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature. Specifically, *** 106
990 21 CFR 110.10(b)(3) 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, *** 102
2392 21 CFR 110.80(b)(1) 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, *** 100
1405 21 CFR 110.10(b)(6) Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, *** 99
1562 21 CFR 110.35(d) Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, *** 93
1007 21 CFR 110.10(b)(9) 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, *** 90
1556 21 CFR 110.35(b)(2) 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, *** 89
6005 21 CFR 123.6(c)(6) 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, *** 87
1125 21 CFR 110.40(a) Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, *** 85
1066 21 CFR 110.40(b) 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, *** 82
1292 21 CFR 110.20(b)(1) 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, *** 80
6020 21 CFR 123.9(a) 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, *** 79
3658 21 CFR 110.37(e)(2) Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, *** 68
1173 21 CFR 110.40(f) 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,*** 65
1005 21 CFR 110.10(b)(7) Storage of personal items Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils are washed]. Specifically, *** 64
3652 21 CFR 110.37(e)(1) Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, *** 62
4470 21 CFR 108.25(c)(2) 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, *** 62
3659 21 CFR 110.37(e)(3) Hand drying Lack of a sanitary towel service or suitable hand drying devices. Specifically, *** 60
3661 21 CFR 110.37(e)(5) Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, *** 60
15839 21 CFR 111.70(e) Specifications - identity, purity, strength, composition You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement. Specifically, *** 58
933 21 CFR 123.8(a)(2)(ii) Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, *** 57
15858 21 CFR 111.75(a)(1)(i) 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, *** 56
6021 21 CFR 123.10 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, *** 55
1698 21 CFR 110.80(b)(5) Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination. Specifically, *** 53
1599 21 CFR 110.37(b)(5) Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, *** 50
6018 21 CFR 123.7(a) 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,*** 50
1402 21 CFR 110.10(b)(4) Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, *** 48
985 21 CFR 110.10(b)(1) Suitable outer garments Suitable outer garments are not worn that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, *** 47
1578 21 CFR 110.37(f) 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, *** 47
1126 21 CFR 110.40(a) 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, *** 45
1429 21 CFR 110.20(b)(6) 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, *** 45
9931 21 CFR 120.6(b) 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, *** 45
1615 21 CFR 110.93 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination. Specifically, *** 44
6001 21 CFR 123.11(b) Sanitation monitoring documentation "Your sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically***" 43
15869 21 CFR 111.75(c) 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, *** 42
15829 21 CFR 111.70(b)(1) Specifications - component identity You did not establish an identity specification for each component. Specifically, *** 41
906 21 CFR 123.6(b) 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, *** 40
1571 21 CFR 110.35(d)(5) 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, *** 40
15532 21 CFR 111.255(b) Batch record - complete Your batch production record did not include complete information relating to the production and control of each batch. Specifically, *** 40
15861 21 CFR 111.75(a)(2)(ii)(A) 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, *** 40
15927 21 CFR 111.103 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations. Specifically, *** 40
15762 21 CFR 111.205(a) 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, *** 39
1172 21 CFR 110.40(e) 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, *** 38
3086 21 CFR 114.100(b) 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, *** 38
901 21 CFR 123.6(a) 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, *** 37
3071 21 CFR 114.80(a)(1) Scheduled process Acidified food is not manufactured in accordance with the scheduled process. Specifically, *** 37
1406 21 CFR 110.10(b)(6) Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, *** 36
15797 21 CFR 111.553 Written procedures - product complaint You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint. Specifically, *** 36
3656 21 CFR 110.37(d)(3) Self-closing doors Toilet facilities lack self-closing doors. Specifically, *** 35
15830 21 CFR 111.70(b)(2) Specifications-component purity, strength, composition You did not establish component specifications for [purity] [strength] [composition]. Specifically, *** 35
3078 21 CFR 114.80(b) 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, *** 33
6015 21 CFR 123.6(c)(6) 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, *** 33
1006 21 CFR 110.10(b)(8) 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, *** 32
1702 21 CFR 110.80(b)(8) Metal / extraneous materials Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, *** 32
3080 21 CFR 114.83 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, *** 32
3643 21 CFR 110.10(b)(5) Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, *** 32
15641 21 CFR 111.453 Written procedures - holding You did not [establish] [follow written] procedures for holding and distributing operations. Specifically, *** 32
15809 21 CFR 111.570(b)(1) 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, *** 32
1067 21 CFR 110.40(c) 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, *** 31
1696 21 CFR 110.80(b)(3) 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, *** 31
1293 21 CFR 110.20(b)(2) 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, *** 29
1598 21 CFR 110.37(b)(4) Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, *** 29
3647 21 CFR 110.10(c) Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors]. Specifically, *** 28
4511 21 CFR 108.25(f) Approved school Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, *** 28
1602 21 CFR 110.37(a) 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, *** 27
4464 21 CFR 108.25(c)(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 acidified foods. Specifically, *** 27
6010 21 CFR 123.8(a)(3)(i) 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, *** 27
12742 21 CFR 120.8(a) HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, *** 27
15659 21 CFR 111.475(b)(1) Written procedures - holding; distributing You did not make and keep written procedures for holding and distributing operations. Specifically, *** 27
1426 21 CFR 110.20(b)(5) 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, *** 26
1565 21 CFR 110.35(d)(3) Non-food-contact surfaces (S) Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, *** 26
1709 21 CFR 110.80(b)(13) Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, *** 26
16042 21 CFR 111.503 Written procedures - returned dietary supplement You did not [establish] [follow] written procedures for when a returned dietary supplement is received. Specifically, *** 26
1570 21 CFR 110.35(d)(5) Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, *** 25
2361 21 CFR 110.80 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, *** 25
6007 21 CFR 123.9(a) Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed. Specifically, *** 25
15531 21 CFR 111.255(a) Batch record - every batch You did not prepare a batch production record every time you manufactured a batch of dietary supplement. Specifically, *** 25
6016 21 CFR 123.6(c)(7) Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, *** 24
15763 21 CFR 111.205(a) 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, *** 24
1129 21 CFR 110.40(a) Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces. Specifically, *** 23
1132 21 CFR 110.40(a) 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, *** 23
1184 21 CFR 110.35(e) 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, *** 23
6006 21 CFR 123.6(c)(7) Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, *** 23
6022 21 CFR 123.12(c) 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, *** 23
9955 21 CFR 120.11(a)(1) 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, *** 23
3062 21 CFR 114.10 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, *** 22
3073 21 CFR 114.80(a)(2) 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, *** 21
12746 21 CFR 120.8(b)(2) 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, *** 21
15897 21 CFR 111.83(a) Reserve sample - collect, hold You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed. Specifically, *** 21
1763 21 CFR 110.35(b)(1) 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, *** 20
3654 21 CFR 110.37(d)(1) Maintained Failure to maintain toilet facilities in a sanitary condition. Specifically, *** 20
931 21 CFR 123.8(d) Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, *** 19
1090 21 CFR 110.40(d) 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, *** 19
1289 21 CFR 110.20(a)(3) 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, *** 19
1561 21 CFR 110.35(c) 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, *** 19
3075 21 CFR 114.80(a)(4) Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination. Specifically, *** 19
4515 21 CFR 108.35(c)(2) 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, *** 19
4519 21 CFR 108.35(c)(3)(i) Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, *** 19
9947 21 CFR 120.11(b) 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, *** 19
12745 21 CFR 120.8(b)(1) HACCP plan - food hazards not listed Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, *** 19
12747 21 CFR 120.8(b)(3) 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, *** 19
1128 21 CFR 110.40(a) Installation and maintenance of equipment (S) Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, *** 18
1403 21 CFR 110.10(b)(4) 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, *** 18
1425 21 CFR 110.20(b)(4) Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, *** 17
3655 21 CFR 110.37(d)(2) Good repair Failure to keep toilet facilities in good repair. Specifically, *** 17
6019 21 CFR 123.8(a)(2) 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, *** 17
9932 21 CFR 120.6(a) 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, *** 17
9941 21 CFR 120.8(a) 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, *** 17
15747 21 CFR 111.210(g) 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, 17
16135 21 CFR 118.4(b)(4) Stray animals Stray animals are not prevented from entering poultry houses. Specifically,*** 17
4475 21 CFR 108.25(c)(3)(i) Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, *** 16
15819 21 CFR 111.55 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, *** 16
913 21 CFR 123.8(a)(1) 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, *** 15
6014 21 CFR 123.6(c)(2) 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, 15
9930 21 CFR 120.6(c) 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, *** 15
9935 21 CFR 120.7(a) 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, ***" 15
12734 21 CFR 120.12(a) 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, *** 15
16057 21 CFR 111.535(b)(1) Records - returned dietary supplement: written procedures You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements. Specifically, *** 15
16118 21 CFR 118.4 Written SE plan not implemented/followed Your written SE prevention plan is not [fully] implemented and followed. Specifically,*** 15
986 21 CFR 110.10(b)(2) Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness. Specifically, *** 14
1130 21 CFR 110.40(a) 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, *** 14
1596 21 CFR 110.37(b)(2) 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, *** 14
2388 21 CFR 110.80(a)(5) 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, *** 14
3067 21 CFR 114.80(a) Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "*** 14
3082 21 CFR 114.89 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, *** 14
3085 21 CFR 114.100(a) 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, *** 14
9943 21 CFR 120.8(a) 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, *** 14
12748 21 CFR 120.8(b)(5) HACCP plan - corrective action plan not included Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected]. Specifically,*** 14
12755 21 CFR 120.11(a)(1)(iv) 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, ***" 14
15828 21 CFR 111.70(a) 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, *** 14
15838 21 CFR 111.70(d) Specifications - labels, packaging "You did not establish [label] [packaging] specifications. Specifically, ***" 14
15862 21 CFR 111.75(a)(2) 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, *** 14
1568 21 CFR 110.35(d)(2) 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, *** 13
4479 21 CFR 108.25(e) 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, *** 13
9958 21 CFR 120.12(c) 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, *** 13
16204 21 CFR 118.10(b)(2) Date and time of activity All your required records do not include the [date] [time] of the activity that the records reflect. Specifically,*** 13
9939 21 CFR 120.7(c) 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, *** 12
15737 21 CFR 111.210(h)(5) Corrective action plans The written instructions in your master manufacturing did not include instructions for corrective action plans to use when specifications are not met. Specifically, *** 12
15796 21 CFR 111.430(b) Records - packaging, labeling operations You did not make and keep records of the written procedures for [packaging] [labeling] operations. Specifically, *** 12
15831 21 CFR 111.70(b)(3) Specifications - contamination limits You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, *** 12
16013 21 CFR 111.140(b)(1) Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations. Specifically, *** 12
1316 21 CFR 113.87(c) 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, *** 11
2385 21 CFR 110.80(a)(1) 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, *** 11
2393 21 CFR 110.80(b)(1) Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, *** 11
3662 21 CFR 110.37(e)(6) Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, *** 11
3877 21 CFR 113.60(c) Coding - required elements The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed] [period during which packed]. Specifically, *** 11
12749 21 CFR 120.8(b)(6) 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, *** 11
15410 21 CFR 111.14(b)(2) Personnel - records - training You did not make and keep documentation of training. Specifically, *** 11
15425 21 CFR 111.15(i) Hand-washing facilities Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature]. Specifically, *** 11
15748 21 CFR 111.210(f) Master manufacturing record theoretical and 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] [the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made]. Specifically, *** 11
15761 21 CFR 111.205(b)(1) 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, *** 11
16193 21 CFR 118.10(a)(3)(ii) Rodent and pest control documentation You did not maintain records documenting compliance with rodent and other pest control measures. Specifically,*** 11
1642 21 CFR 113.100(b) 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, *** 10
2384 21 CFR 110.80(a)(7) 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, *** 10
4524 21 CFR 108.35(g) 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, *** 10
12743 21 CFR 120.8(b)(4) 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, *** 10
15404 21 CFR 111.12(c) 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, *** 10
15492 21 CFR 111.25(a) 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, *** 10
15642 21 CFR 111.455(a) 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, *** 10
16120 21 CFR 118.4 Written SE plan lacks required elements Your written SE prevention plan lacks appropriate SE prevention measures. Specifically,*** 10
16122 21 CFR 118.4(a)(2)(i) Pullet environment testing Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,*** 10
929 21 CFR 123.8(b) 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, *** 9
932 21 CFR 123.7(d) Corrective action documentation You do not have records that document corrective actions that were taken. Specifically, *** 9
1711 21 CFR 110.80(b)(15) 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, *** 9
1766 21 CFR 110.35(b)(1) 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, *** 9
3712 21 CFR 110.93 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, *** 9
6017 21 CFR 123.7(c) 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, *** 9
15546 21 CFR 111.260(f) 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, *** 9
15825 21 CFR 111.65 Quality control - quality, dietary supplement You did not implement quality control operations to ensure the quality of the dietary supplement. Specifically, *** 9
15843 21 CFR 111.70(g) 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, *** 9
16203 21 CFR 118.10(b)(1) Name and location All required records do not include [your name] [the location of your farm]. Specifically,*** 9
975 21 CFR 123.9(b)(1) Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically, *** 8
2387 21 CFR 110.80(a)(1) Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, *** 8
2394 21 CFR 110.80(b)(6) 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, *** 8
4181 21 CFR 113.89 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, *** 8
6009 21 CFR 123.8(a)(3)(iii) Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, *** 8
9928 21 CFR 120.12(b) 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, *** 8
15434 21 CFR 111.15(d)(2) 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, *** 8
15494 21 CFR 111.25(c) 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, *** 8
15496 21 CFR 111.27(b) Instruments - calibration You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine intervals or as necessary] to ensure the accuracy and precision of the instruments or controls. Specifically, *** 8
15543 21 CFR 111.260(c) 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, *** 8
15930 21 CFR 111.105 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, *** 8
16058 21 CFR 111.535(b)(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, *** 8
16172 21 CFR 118.7(a) Plan appropriate to layout The poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,*** 8
918 21 CFR 123.8(a) 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, *** 7
938 21 CFR 123.9(c) 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, *** 7
1577 21 CFR 110.37(f) 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, *** 7
1697 21 CFR 110.80(b)(4) 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, *** 7
1731 21 CFR 113.40(a)(2) Presence and accuracy Each retort did not have an accurate temperature-recording device. Specifically, *** 7
2427 21 CFR 110.80(b)(9) 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, *** 7
3083 21 CFR 114.89 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, *** 7
3651 21 CFR 110.37(b)(5) Cross contamination Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, *** 7
3657 21 CFR 110.37(d)(4) 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, *** 7
3660 21 CFR 110.37(e)(4) Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, *** 7
15560 21 CFR 111.260(k)(2) Batch record - label Your batch production records did not include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. Specifically, *** 7
15744 21 CFR 111.210(h)(2) 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, *** 7
15871 21 CFR 111.75(c)(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, *** 7
15928 21 CFR 111.103 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, *** 7
15932 21 CFR 111.105(a) 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, *** 7
16040 21 CFR 111.610(a) 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, *** 7
16134 21 CFR 118.4(b)(3) Cross contamination from people You do not maintain practices that will protect against cross contamination when people move between poultry houses. Specifically,*** 7
16152 21 CFR 118.5(a) Testing when laying hens 40 to 45 weeks Environmental testing for SE, using approved methods, was not done in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,*** 7
16192 21 CFR 118.10(a)(3)(1) Biosecurity measures documentation You did not maintain records documenting compliance with biosecurity measures. Specifically,*** 7
950 21 CFR 123.12(d) 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, *** 6
1329 21 CFR 113.100(a) 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, *** 6
1566 21 CFR 110.35(d)(4) 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, *** 6
1641 21 CFR 113.100(b) 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, *** 6
1688 21 CFR 110.80 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, *** 6
2301 21 CFR 129.80(f) Bacteriological swab, rinse count - containers, closures (S) You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing. Specifically, *** 6
2362 21 CFR 110.80 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, *** 6
3077 21 CFR 114.80(b) Visible code Each container is not marked with an identifying code permanently visible to the naked eye. Specifically, *** 6
3088 21 CFR 114.100(b) 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, *** 6
3090 21 CFR 114.100(d) Product distribution Records identifying initial distribution of finished product are not maintained. Specifically, *** 6
9961 21 CFR 120.24(a) 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, *** 6
9981 21 CFR 120.12(b)(4) Records - actual values Your records do not [always] contain the actual values and observations obtained during monitoring. Specifically, *** 6
15401 21 CFR 111.12(b) Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations. Specifically, *** 6
15402 21 CFR 111.12 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, *** 6
15453 21 CFR 111.16 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, *** 6
15499 21 CFR 111.27(a) 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, *** 6
15545 21 CFR 111.260(e) Batch record - component; identity, weight Your batch production records did not include the [identity] [weight or measure] of each component used. Specifically, *** 6
15681 21 CFR 111.315(d) Standard reference materials; criteria for selecting You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations. Specifically, *** 6
15733 21 CFR 111.365 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, *** 6
15759 21 CFR 111.205(b)(2) Master manufacturing record - controls, procedures Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically, *** 6
15790 21 CFR 111.403 Written procedures - labeling operations You did not [establish] [follow] written procedures for labeling operations. Specifically, *** 6
15801 21 CFR 111.560(b) Quality control, review, approve; investigate, follow-up 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, *** 6
15841 21 CFR 111.70(f) 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, 6
16014 21 CFR 111.140(b)(1) QC ops; written procedures; material review, disposition You did not make and keep [written procedures for the responsibilities of the quality control operations for conducting a material review and making a disposition decision] [written procedures for approving or rejecting any reprocessing]. Specifically, *** 6
16142 21 CFR 118.4(c)(3) Removal of pest harborages Potential harborages for pests in and outside your poultry house have not been eliminated by [removing debris within a poultry house] [removing debris and vegetation outside the poultry house]. Specifically,*** 6
16179 21 CFR 118.8(a) Method to be used, environmental samples For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE. Specifically,*** 6
16195 21 CFR 118.10(a)(3)(iv) Refrigeration requirements documentation You do not maintain records documenting compliance with refrigeration requirements. Specifically*** 6
16205 21 CFR 118.10(b)(3) Signatures or initials on operational records All required records do not have the signature or initials of the person performing the operation or creating the record. Specifically,*** 6
16206 21 CFR 118.10(b)(3) Signature and date on SE plans Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s) who administer the plan]. Specifically,*** 6
939 21 CFR 123.9(f) Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. Specifically, *** 5
1290 21 CFR 110.20(a)(4) 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, *** 5
1331 21 CFR 113.100(a)(1) 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, *** 5
1471 21 CFR 113.83 Scheduled processes not established Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing. Specifically, *** 5
1473 21 CFR 113.83 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. 5
1648 21 CFR 113.40(a)(1) No MIG thermometer Failure to install a mercury-in glass thermometer on each retort. Specifically, *** 5
2167 21 CFR 113.40(b)(9) No indicator There is no means to determine the water level in a retort during operations. Specifically, *** 5
3072 21 CFR 114.80(a)(1) 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, *** 5
3653 21 CFR 110.37(d) Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, *** 5
3709 21 CFR 110.80(a)(1) 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, *** 5
3866 21 CFR 113.60(a)(1)(i)(a) Required can seam measurements (micrometer) Records of the results of micrometer measurements of double seam cans fail to include [cover hook] [body hook] [width] [tightness] [thickness]. Specifically, *** 5
3874 21 CFR 113.60(b) 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, *** 5
9926 21 CFR 120.14(a) Importer - written procedures You do not have written procedures that describe [product specifications] [affirmative steps] to ensure that juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, *** 5
9936 21 CFR 120.7(a) 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, *** 5
9954 21 CFR 120.11(a)(1)(iv) 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, *** 5
12720 21 CFR 1.225 Not registered Your food facility is not registered as required. Specifically, *** 5
12754 21 CFR 120.11(a)(1)(iv)(C) 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, *** 5
15381 21 CFR 111.8 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices. Specifically, *** 5
15454 21 CFR 111.16 Written procedures - pest control You did not [establish] [follow] written procedures for pest control. Specifically, *** 5
15480 21 CFR 111.20(h) Physical plant - screening against pests Your physical plant did not use adequate screening or other protection against pests. Specifically, *** 5
15491 21 CFR 111.25 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils. Specifically, *** 5
15498 21 CFR 111.27(d) 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, *** 5
15566 21 CFR 111.260(l)(3) 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, *** 5
15645 21 CFR 111.455(c) Hold - mix-up, contamination, deterioration You held [components] [dietary supplements] [packaging] [labels] under conditions that lead to mix-up, contamination, or deterioration. Specifically, *** 5
15723 21 CFR 111.365(i) 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, *** 5
15736 21 CFR 111.353 Manufacturing operations - written procedures You did not [establish] [follow] written procedures for manufacturing operations. Specifically, *** 5
15840 21 CFR 111.70(e) 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, *** 5
15853 21 CFR 111.73 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, *** 5
15864 21 CFR 111.75(a)(2)(ii)(C) Documentation - qualify supplier You did not maintain documentation of how you qualified the supplier of a component. Specifically, *** 5
15984 21 CFR 111.123(a)(8) Quality control - finished batch, distribution Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution. Specifically, *** 5
15986 21 CFR 111.123(b)(2) Quality control - batch, product specifications Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications. Specifically, *** 5
16070 21 CFR 111.35(b)(2) 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, *** 5
16072 21 CFR 111.35(b)(3) 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, *** 5
16133 21 CFR 118.4(b)(2) Cross contamination from equipment You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses. Specifically,*** 5
1196 21 CFR 110.10(a) 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, *** 4
1317 21 CFR 113.87(d) Timing devices Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved. Specifically, *** 4
1487 21 CFR 113.87(b) 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, *** 4
1569 21 CFR 110.35(d)(2) Continuous operations Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary. Specifically, *** 4
1600 21 CFR 110.37(a) General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, *** 4
1651 21 CFR 113.40(a)(1) Thermometer calibration Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy. Specifically, *** 4
1669 21 CFR 110.80(a)(3) 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, *** 4
2389 21 CFR 110.80(a)(5) Identify rework Failure to identify material scheduled for rework as such. Specifically, *** 4
2396 21 CFR 110.80(b)(6) Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination. Specifically, *** 4
2886 21 CFR 113.40(i) 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, *** 4
3079 21 CFR 114.80(b) Code - packing period The packing period is not changed often enough to enable ready identification of lots during sale and distribution Specifically, *** 4
3089 21 CFR 114.100(c) 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, *** 4
3864 21 CFR 113.60(a)(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, *** 4
4069 21 CFR 113.40(b)(13) Retort configuration Failure to have data on file which demonstrates that the heat distribution is adequate for retort installations which deviate from the diagrams in 21 CFR 113.40(b)(13). Specifically, *** 4
4514 21 CFR 108.35(c)(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, *** 4
4529 21 CFR 108.35(c)(2)(ii) 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, *** 4
6002 21 CFR 123.11(b) Sanitation corrections You did not correct sanitation deficiencies in a timely manner. Specifically,*** 4
6012 21 CFR 123.8(a)(3)(iii) 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, *** 4
9963 21 CFR 120.24(c) 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, *** 4
9986 21 CFR 120.24(c) 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, *** 4
12732 21 CFR 120.10(a) 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, *** 4
15302 21 CFR 120.11(a)(2) Calibration, testing - no records You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, *** 4
15409 21 CFR 111.14(b)(1) 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, *** 4
15442 21 CFR 111.15(b)(1) Physical plant - clean and sanitary You did not maintain your physical plant in a clean and sanitary condition. Specifically, *** 4
15443 21 CFR 111.15(b)(2) 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, *** 4
15481 21 CFR 111.23(b) Records - cleaning, pest control You did not make and keep records of the written procedures for [cleaning the physical plant] [pest control]. Specifically, *** 4
15493 21 CFR 111.25(b) Procedures - calibrating automated, mechanical equip You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment. Specifically, *** 4
15525 21 CFR 111.30(b) Equipment - automated - suitability You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process. Specifically, *** 4
15542 21 CFR 111.260(b) 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, *** 4
15544 21 CFR 111.260(d) 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, *** 4
15556 21 CFR 111.260(j)(2)(iv) Batch record - initials; verifying component Your batch production records did not include initials of the person responsible for verifying the addition of components to the batch. Specifically, *** 4
15567 21 CFR 111.260(l)(4) Batch record - approved, released, rejected Your batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement. Specifically, *** 4
15598 21 CFR 111.160(d)(1) Packaging - identify You did not identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the packaging] [the dietary supplement that you distributed]. Specifically, *** 4
15662 21 CFR 111.303 Written procedures - laboratory operations You did not [establish] [follow] written procedures for laboratory operations. Specifically, *** 4
15702 21 CFR 111.320(b) 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, *** 4
15712 21 CFR 111.325(b)(2)(ii) Records - document; results The documentation for laboratory tests and examinations did not include the results of the testing and examination. Specifically, *** 4
15715 21 CFR 111.375(b) Records - manufacturing operations; written procedures You did not make and keep records of the written procedures for manufacturing operations. Specifically, *** 4
15732 21 CFR 111.365(a) Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination]. Specifically, *** 4
15745 21 CFR 111.210(h)(1) Instructions; specifications; packaged, labeled The written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Specifically, *** 4
15774 21 CFR 111.415(f)(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, *** 4
15784 21 CFR 111.410(c) 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, *** 4
15800 21 CFR 111.560(a)(2) 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, *** 4
15842 21 CFR 111.70(f) 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, *** 4
15870 21 CFR 111.75(c)(1) 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, *** 4
15891 21 CFR 111.80(a) 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, *** 4
15989 21 CFR 111.127 Quality control operations - packaging, labeling You do not have quality control operations for [packaging] [labeling]. Specifically, *** 4
16000 21 CFR 111.130 Quality control operations - returned dietary supplement You do not have quality control operations for returned dietary supplements. Specifically, *** 4
16089 FDCA 417(d)(1)(A) 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, *** 4
16138 21 CFR 118.4(c)(1) Monitoring for rodents The presence of rodents is not monitored by appropriate monitoring methods. Specifically,*** 4
949 21 CFR 123.12(c) Records, English The records that document the performance and results of the affirmative step you chose are not in English. Specifically, *** 3
1045 21 CFR 113.10 Supervisors Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility. Specifically, *** 3
1188 21 CFR 110.37(c) Sewage disposal Failure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, *** 3
1288 21 CFR 110.20(a)(2) 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, *** 3
1303 21 CFR 113.81(f) 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, *** 3
1472 21 CFR 113.83 Critical factors not stated Critical factors that may affect the scheduled process are not specified in the scheduled process. Specifically, *** 3
1500 21 CFR 113.89 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority. Specifically, *** 3
1531 21 CFR 113.100(a)(6) Water activity Forms used in recording specific processing and production information for food preservation methods such as water activity in conjunction with thermal processing lack [product formulation] [scheduled processes used] [thermal process] [associated and other critical factors] [results of water activity determinations]. Specifically, *** 3
1534 21 CFR 113.100(b) 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, *** 3
1563 21 CFR 110.35(d)(1) Low-moisture food requirements Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use. Specifically, *** 3
1595 21 CFR 110.37(b)(1) 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, *** 3
1640 21 CFR 113.100(b) Entries not signed The retort or processing system operator or other designated person did not initial or sign each record form. Specifically, *** 3
1649 21 CFR 113.40(a)(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, *** 3
1691 21 CFR 113.40(a)(4) Steam controller Failure to equip retorts with automatic steam controllers to maintain retort temperatures. Specifically, *** 3
1708 21 CFR 110.80(b)(12) 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, *** 3
1710 21 CFR 110.80(b)(14) Water activity controls Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms. Specifically, *** 3
1806 21 CFR 129.80(b)(1) Mechanical washers - records You did not keep records of [inspections and conditions found] [physical maintenance] [performance] for mechanical washers. Specifically, *** 3
2150 21 CFR 113.40(b)(2) Presence and accuracy Each retort did not have an accurate temperature-recording device. Specifically, *** 3
2271 21 CFR 129.80(e) Package identification You did 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, *** 3
2837 21 CFR 113.40(g)(4) 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, *** 3
3645 21 CFR 110.10(d) Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned to competent supervisory personnel. Specifically, *** 3
3710 21 CFR 110.80(b)(16) Ice manufacturing Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality]. Specifically, *** 3
3857 21 CFR 113.60(a) Record of visual closure examination Failure to record observations of visual closure examinations performed by a qualified person during production. Specifically, *** 3
3876 21 CFR 113.60(c) Coding - failure to mark Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye. Specifically, *** 3
3885 21 CFR 113.87(c) IT of cans in water filled retorts Failure to assure that the initial temperature of cans exposed to water during filling or operating of the retort was not lower than the initial temperature specified in the scheduled process. Specifically, *** 3
4179 21 CFR 113.83 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, *** 3
4295 21 CFR 110.40(a) Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials. Specifically, *** 3
4419 21 CFR 110.10(c) 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, *** 3
4517 21 CFR 108.35(c)(2)(ii) 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, *** 3
4523 21 CFR 108.35(f) Recall procedures Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, *** 3
9946 21 CFR 120.11(b) 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, *** 3
9953 21 CFR 120.11(a)(1)(iv)(A) 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, *** 3
12751 21 CFR 120.8(b)(7) HACCP plan - recordkeeping system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, *** 3
15351 FDCA 761(b)(1) 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, *** 3
15382 21 CFR 111.8 Written procedures - personnel qualifications You did not [establish] [follow] written procedures for determining personnel qualification requirements. Specifically, *** 3
15452 21 CFR 111.15(f)(5) 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, *** 3
15526 21 CFR 111.30(c) Equipment - automated - calibrate, inspect You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance. Specifically, *** 3
15548 21 CFR 111.260(h) Batch record - results; testing, examination; batch Your batch production records did not include the results of testing or examination performed during batch production, or a cross-reference to such results. Specifically, *** 3
15549 21 CFR 111.260(i) Batch record - specifications Your batch production records did not include documentation that the finished dietary supplement meets established specifications. Specifically, *** 3
15550 21 CFR 111.260(j) Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch. Specifically, *** 3
15552 21 CFR 111.260(j)(2) Batch record - initials; each step Your batch production records did not include initials of the persons performing each step. Specifically, *** 3
15554 21 CFR 111.260(j)(2)(ii) 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, *** 3
15557 21 CFR 111.260(k) Batch record - packaging, labeling Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations. Specifically, *** 3
15559 21 CFR 111.260(k)(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, *** 3
15580 21 CFR 111.155(c)(2) 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, *** 3
15583 21 CFR 111.155(d)(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, *** 3
15599 21 CFR 111.160(d)(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, ***" 3
15652 21 CFR 111.465(b) Retain reserve samples - 1 year, 2 years You did not retain reserve samples for the required time. Specifically, *** 3
15658 21 CFR 111.475(a) Records - holding, distribution: readily available You did not have records or copies of records required for your holding and distributing operations readily available during the required retention period for inspection and copying by FDA when requested. Specifically, *** 3
15675 21 CFR 111.315(b) Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples. Specifically, *** 3
15746 21 CFR 111.210(h)(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, *** 3
15791 21 CFR 111.403 Written procedures -packaging operations You did not [establish] [follow] written procedures for packaging operations. Specifically, *** 3
15799 21 CFR 111.560(a)(1) 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, *** 3
15810 21 CFR 111.570(b)(2) Record - product complaint; good manufacturing practice You did not make and keep a written record of every product complaint that was related to good manufacturing practice. Specifically, *** 3
15817 21 CFR 111.570(b)(2)(ii)(F) Record - product complaint; findings The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken]. Specifically, *** 3
15847 21 CFR 111.73 Specifications met - component identity You did not determine whether you met identity specifications established for components. Specifically, *** 3
15882 21 CFR 111.75(h)(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, *** 3
15885 21 CFR 111.77(a) 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, *** 3
15933 21 CFR 111.105(b) Quality control - supplier qualification Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers. Specifically, *** 3
15944 21 CFR 111.105(i) 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, *** 3
15954 21 CFR 111.113(a)(2) 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, *** 3
15970 21 CFR 111.120 Quality control operations - components, packaging, labels You do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically, *** 3
15975 21 CFR 111.120(e) 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, *** 3
15976 21 CFR 111.123 Quality control operations - master, batch, manufacturing You do not have quality control operations required for the [master manufacturing record] [batch production record] [manufacturing operations]. Specifically, *** 3
15977 21 CFR 111.123(a)(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, *** 3
15978 21 CFR 111.123(a)(2) Quality control operations - batch production records Your quality control operations did not include reviewing and approving all batch production-related records. Specifically, *** 3
16071 21 CFR 111.35(b)(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, *** 3
16117 21 CFR 118.4 No written SE prevention plan Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you produce eggs. Specifically,*** 3
16132 21 CFR 118.4(b)(1) Limiting visitors Visitors are not limited [on the farm] [in the poultry houses]. Specifically,*** 3
16136 21 CFR 118.4(b)(5) Employees keeping birds at home Employees are allowed to keep birds at home. Specifically,*** 3
16141 21 CFR 118.4(c)(2) Satisfactory fly control methods When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control. Specifically,*** 3
16171 21 CFR 118.7(a) Environmental test An environmental test for SE was not done for each poultry house as required. Specifically,*** 3
16194 21 CFR 118.10(a)(3)(iii) Depopulation cleaning and disinfection procedures You did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation. Specifically,*** 3
16207 21 CFR 118.10(b)(4) Data and information re: compliance activities Data and information reflecting compliance activities [is not entered on records at the time the activity is performed or observed] [does not indicate the actual values]. Specifically*** 3
976 21 CFR 123.9(b)(2) Process adequacy records The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their applicability to the product you produced. Specifically, *** 2
1176 21 CFR 110.40(f) 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,*** 2
1255 21 CFR 129.20(a) Bottling room separation, plant operations The bottling room was not separated from other plant operations by [tight walls] [ceilings] [self-closing doors] to protect against contamination. Specifically, *** 2
1330 21 CFR 113.100(a) 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, *** 2
1428 21 CFR 110.20(b)(6) Adequate ventilation Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food. Specifically, *** 2
1483 21 CFR 113.87(a) 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, *** 2
1484 21 CFR 113.87(a) Vent not posted Retort venting procedures for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators]. Specifically, *** 2
1486 21 CFR 113.87(b) System not established A system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, *** 2
1529 21 CFR 113.89 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, *** 2
1601 21 CFR 110.37(a) Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, *** 2
1639 21 CFR 113.100(b) 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, *** 2
1660 21 CFR 113.40(a)(1) MIG thermometer not used as reference The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures. Specifically, *** 2
1670 21 CFR 110.80(a)(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, *** 2
1734 21 CFR 113.40(a)(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] the mercury-in-glass thermometer during processing. Specifically, *** 2
1757 21 CFR 113.40(a)(8) Observable Failure to install bleeders so that the operator can observe that they are functioning properly. Specifically, *** 2
1944 21 CFR 129.80(d) Sanitizing operations inadequate Sanitizing operations were not adequate to sanitize the intended [product water-contact surfaces] [critical areas]. Specifically, *** 2
1945 21 CFR 129.80(d) Records - sanitizing times, intensities (S) You did 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, *** 2
2101 21 CFR 113.40(a)(13) 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, *** 2
2142 21 CFR 113.40(b)(1) No MIG thermometer Failure to install a mercury-in glass thermometer on each retort. Specifically, *** 2
2272 21 CFR 129.80(e) Records - product, volume, date, code, distribution You did 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, *** 2
2274 21 CFR 129.80(g)(1) Bacteriological test - bottled water You did 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, *** 2
2298 21 CFR 129.80(f) Inspection - containers, closures You did not [sample] [inspect] all containers and closures to ascertain they are free from contamination. Specifically, *** 2
2856 21 CFR 113.40(g)(1)(i)(e) Calibration The differential pressure recorder-controller was not tested [upon installation] [every three months of operation] [as frequently as necessary] against a known accurate standard pressure indicator. Specifically, *** 2
2887 21 CFR 113.40(j) 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, *** 2
2889 21 CFR 113.40(g)(2)(i)(a) 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, *** 2
2901 21 CFR 113.40(i) 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, *** 2
3074 21 CFR 114.80(a)(2) Using pH meter Failure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH] when the finished equilibrium pH is above 4.0. Specifically, *** 2
3093 21 CFR 114.89 Process deviation evaluation - record Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, *** 2
15623 21 CFR 111.180(b)(2) 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, *** 2
3648 21 CFR 110.20(a)(4) Neighboring grounds Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control. Specifically, *** 2
3872 21 CFR 113.60(a)(3) 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, *** 2
4062 21 CFR 113.100(a) Critical factors - entry missing information Forms used to record critical factors lack [closing machine vacuum in vacuum-packed products] [maximum fill-in weight] [drained weight] [critical factors specified in the scheduled process]. Specifically, *** 2
4465 21 CFR 114.100(c) Process deviations - action to rectify Failure to record the action taken to rectify a departure from a scheduled process. Specifically, *** 2
4476 21 CFR 108.25(c)(3)(ii) Process information availability Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, *** 2
4512 21 CFR 108.25(g) 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, *** 2
9917 21 CFR 120.10(c) Corrective action documentation You do not have records that [fully] document corrective actions that were taken. Specifically, *** 2
9933 21 CFR 120.6(b) GMP correction - timely You do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, *** 2
12744 21 CFR 120.8(b)(4) 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, *** 2
12750 21 CFR 120.8(b)(6) 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, *** 2
15352 FDCA 761(b)(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, *** 2
15403 21 CFR 111.12(b) 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, *** 2
15427 21 CFR 111.15(h) Bathrooms - adequate, accessible You did not provide your employees with [adequate] [readily accessible] bathrooms. Specifically, *** 2
15447 21 CFR 111.15(c)(3) Cleaning compounds and toxic materials - holding You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces. Specifically, *** 2
15450 21 CFR 111.15(f)(3) Plumbing - source of contamination The plumbing in your physical plant was not adequate to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface or creating an unsanitary condition. Specifically, *** 2
15465 21 CFR 111.20(d)(2) Air blowing equipment Air-blowing equipment was not [located] [operated] to minimize the potential for microorganisms or particulate matter to contaminate components, dietary supplements, or contact surfaces. Specifically, *** 2
15473 21 CFR 111.20(c)(7) 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, *** 2
15478 21 CFR 111.20(f) Physical plant - bulbs, fixtures, skylights You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary supplements. Specifically, *** 2
15505 21 CFR 111.27(a)(3)(v) Equipment - protect from contamination Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated. Specifically, *** 2
15506 21 CFR 111.27(a)(4) Equipment - bonded seams You used equipment or utensils that do not have seams that are smoothly bonded or maintained to minimize accumulation of extraneous materials or contaminants. Specifically, *** 2
15508 21 CFR 111.27(a)(5)(ii) Refrigerator, freezer - alarm Your freezer, refrigerator, or other cold storage compartments that you use to hold components or dietary supplements does not have either an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change. Specifically, *** 2
15521 21 CFR 111.27(d)(6) Cleaning compounds - adequate, safe Cleaning compounds or sanitizing agents were not [adequate for their intended use] [safe under their conditions of use]. Specifically, *** 2
15533 21 CFR 111.255(c) Batch record - follow master Your batch production record did not accurately follow the appropriate master manufacturing record. Specifically, *** 2
15534 21 CFR 111.255(c) Batch record - each step "You did not perform each step in the production of a batch, according to the master production record. Specifically, ***" 2
15539 21 CFR 111.260(a)(1) Batch record - control number, finished batch Your batch production records did not include the batch, lot, or control number of the finished batch of dietary supplement. Specifically, *** 2
15547 21 CFR 111.260(g) Batch record - results; monitoring Your batch production records did not include the actual results obtained during a monitoring operation. Specifically, *** 2
15553 21 CFR 111.260(j)(2)(i) Batch record - initials; weighing Your batch production records did not include the initials of the person responsible for weighing or measuring each component used in the batch. Specifically, *** 2
15555 21 CFR 111.260(j)(2)(iii) Batch record - initials; component Your batch production records did not include the initials of the person responsible for adding a component to the batch. Specifically, *** 2
15558 21 CFR 111.260(k)(1) Batch record - identifier; packaging Your batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used]. Specifically, *** 2
15561 21 CFR 111.260(k)(3) 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, *** 2
15570 21 CFR 111.153 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements. Specifically, *** 2
15572 21 CFR 111.153 Written procedures - labels You did not [establish] [follow] written procedures for the requirements for labels received. Specifically, *** 2
15578 21 CFR 111.155(c) Components - quarantine You did not quarantine components before you used them in the manufacture of a dietary supplement. Specifically, *** 2
15579 21 CFR 111.155(c)(1) Components - representative samples You did not collect representative samples of components while the components were quarantined. Specifically, *** 2
15604 21 CFR 111.165(b) 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, *** 2
15605 21 CFR 111.165© Product received - quarantine You did not quarantine received product. Specifically, *** 2
15610 21 CFR 111.165(d)(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, ***" 2
15649 21 CFR 111.465(a)(1) Hold - reserve samples; ordinary storage You did not hold reserve samples [under conditions consistent with product labels] [under ordinary storage conditions]. Specifically, *** 2
15660 21 CFR 111.475(b)(2) Records - product distribution You did not make and keep records of product distribution. Specifically, *** 2
15665 21 CFR 111.303 Written procedures - tests, examinations; specifications met You did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met. Specifically, *** 2
15722 21 CFR 111.365(j) Containers - segregating, identifying You did not segregate and identify containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing. Specifically, *** 2
15728 21 CFR 111.365(d) 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, *** 2
15730 21 CFR 111.365(c) Water - Federal, State, local requirements The water you used that may become a component of a finished batch of dietary supplement, did not at minimum comply with the applicable Federal, State, and local requirements. Specifically, *** 2
15734 21 CFR 111.360 Manufacturing operations - sanitation You did not conduct manufacturing operations in accordance with adequate sanitation principles. Specifically, *** 2
15741 21 CFR 111.210(h)(3)(i) Components, verify weight, measure The written instructions in your master manufacturing record did not include instructions to verify the weight or measure and addition of components. Specifically, *** 2
15742 21 CFR 111.210(h)(3) Specific actions; packaged, labeled The written instructions in your master manufacturing record did not include specific actions to perform and verify 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, *** 2
15750 21 CFR 111.210(d) Master manufacturing record - ingredients list Your master manufacturing record did not include the identity of each ingredient that will be declared on the ingredients list of the dietary supplement. Specifically, *** 2
15752 21 CFR 111.210(c) 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, *** 2
15753 21 CFR 111.210(b) Master manufacturing record - list components Your master manufacturing record did not include a complete list of components to be used. Specifically, *** 2
15760 21 CFR 111.205(b)(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, *** 2
15779 21 CFR 111.415(a) Clean, sanitize - filling, packaging equipment You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement packaging], as appropriate. Specifically, *** 2
15783 21 CFR 111.410(d) Manufacturing history You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution. Specifically, *** 2
15785 21 CFR 111.410(b) Label, packaging - discrepancies You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies]. Specifically, *** 2
15786 21 CFR 111.410(b) Labels - issuance, use You did not control the [issuance] [use] of labels, Specifically, *** 2
15812 21 CFR 111.570(b)(2)(ii)(A) Record - product complaint; name, description The written record of a product complaint did not include the name and description of the dietary supplement. Specifically, *** 2
15813 21 CFR 111.570(b)(2)(ii)(B) 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, *** 2
15832 21 CFR 111.70(c)(1) 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, *** 2
15834 21 CFR 111.70(c)(2) 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, *** 2
15835 21 CFR 111.70(c)(2) Documentation specifications - contamination limits You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement. Specifically, *** 2
15860 21 CFR 111.75(a)(2) Component - confirm identity; specifications met You did not confirm the identity of components. Specifically, *** 2
15865 21 CFR 111.75(a)(2)(ii)(D) Re-confirm certificate of analysis You did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, *** 2
15867 21 CFR 111.75(b)(1) Specifications met, in-process - quality finished batch You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met. Specifically, *** 2
15868 21 CFR 111.75(b)(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, *** 2
15872 21 CFR 111.75(c)(3) 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, *** 2
15874 21 CFR 111.75(c)(4) 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, *** 2
15887 21 CFR 111.77(c) Specifications not met - received product identified Your quality control personnel did not reject a product that was not [adequately identified] [consistent with your purchase order]. Specifically, *** 2
15890 21 CFR 111.80(a) Components packaging, labels used You did not collect representative samples of each unique lot of [components] [packaging][ labels] that you used to determine whether the [components] [packaging] [labels] meet(s) established specifications. Specifically, *** 2
15901 21 CFR 111.83(b)(3) Reserve sample - retained You did not retain reserve samples for the required time. Specifically, *** 2
15921 21 CFR 111.95(b)(2) Documentation - supplier qualification You did not make and keep documentation of your qualification of a supplier. Specifically, *** 2
15940 21 CFR 111.105(h) Quality control - production, process control Your quality control personnel did not determine that specifications established for the production and process control system were met. Specifically, *** 2
15941 21 CFR 111.105(i) QC required operations production and process control Your quality control personnel did not perform required operations for the production and process control system. Specifically, *** 2
15952 21 CFR 111.113 Quality control operations - material review, disposition You do not have quality control operations for a material review and disposition decision. Specifically, *** 2
15953 21 CFR 111.113(a)(1) QC production, process control; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met. Specifically, *** 2
15963 21 CFR 111.113(b)(2) 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, *** 2
15972 21 CFR 111.120(b) QC operations -specifications; components, packaging, labels Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications. Specifically, *** 2
15999 21 CFR 111.127(h) 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, *** 2
16007 21 CFR 111.135 Quality control operations - product complaints You do not have quality control operations for product complaints. Specifically, *** 2
16052 21 CFR 111.530 Returned dietary supplement - investigation You did not conduct an investigation of your manufacturing processes, and of each other batch implicated when a dietary supplement was returned, to determine compliance with specifications. Specifically, *** 2
16056 21 CFR 111.535(a) Records - returned dietary supplement: readily available You did not have records or copies of records required for returned dietary supplements readily available during the required retention period for inspection and copying by FDA when requested. Specifically, *** 2
16066 21 CFR 111.35(b)(1)(i) 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, *** 2
16119 21 CFR 118.4(a)(1) Procurement of chicks You do not procure chicks from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for "U.S. S. Enteritidis Clean" or equivalent status. Specifically,*** 2
16131 21 CFR 118.4(b) Transfer or introduction of SE You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or among poultry houses. Specifically,*** 2
16140 21 CFR 118.4(c)(2) Monitoring for flies The presence of flies is not monitored by appropriate monitoring methods. Specifically,*** 2
16149 21 CFR 118.4(e) Egg transport temperature/time Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay. Specifically,*** 2
16183 21 CFR 118.9 Supervisor(s) training/job experience Supervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job experience to administer the SE prevention measures]. Specifically,*** 2
16190 21 CFR 118.10(a)(1) Written SE prevention plan You do not have a written SE prevention plan. Specifically,*** 2
16191 21 CFR 118.10(a)(2) Pullets records documentation You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE monitored" conditions] [that adequate environmental testing records for pullets were kept as required by CFR regulations]. Specifically,*** 2
16198 21 CFR 118.10(a)(3)(vii) Egg diversion documentation You did not maintain records documenting diversion of eggs. Specifically*** 2
16510 FDCA 402(a)(4) On farm processing of shell eggs You have prepared, packed or held shell eggs under insanitary conditions whereby [they may have become contaminated with filth][they may have been rendered injurious to health]. Specifically, *** 2
17004 FDCA 402(a) Food Field Exam During a field examination of food products at your facility the following [was] [were] observed: 2
899 21 CFR 123.16 Process controls Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, *** 1
972 21 CFR 123.8(a)(1) Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. Specifically, *** 1
1060 21 CFR 123.11(a) SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, *** 1
1093 21 CFR 110.40(g) 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, *** 1
1197 21 CFR 110.10(a) Lack of instruction/reporting of health conditions Personnel with adverse health conditions are not instructed to report to their supervisors. Specifically, *** 1
1258 21 CFR 113.60(c) Coding - visible Hermetically sealed containers do not have an identifying code permanently visible to the naked eye. Specifically *** 1
1273 21 CFR 129.20(b) Non-sealed system Processing operations that were conducted in other than a sealed system under pressure did not provide adequate protection against contamination of the water and the system. Specifically, *** 1
1276 21 CFR 129.20(c) Ventilation - condensation The ventilation in the [processing room] [bottling room] [container washing and sanitizing area] was not adequate to minimize condensation. Specifically, *** 1
1325 21 CFR 113.100(e) Record retention Copies of processing, production, and other required records for each lot of a low-acid food processed were not retained at the processing plant [for a one year period following manufacture] [or other reasonably accessible location for a total of a three-year record-retention period]. Specifically, *** 1
1332 21 CFR 113.100(a)(2) Agitating retorts - processing information Forms used in recording specific processing and production information for agitating retorts lack [functioning of the condensate bleeder] [retort speed]. Specifically, *** 1
1334 21 CFR 113.100(a)(4) Aseptic processing Forms used in recording specific processing and production information for aseptic processing and packaging systems lack [the product temperature in the holding tube outlet] [the product temperature in the final heater outlet] [differential pressure] [product flow rate] [sterilization media flow rate] [sterilization media temperature] [retention time of containers and closures] [sterilization cycle times] [sterilization cycle temperatures]. Specifically, *** 1
1348 21 CFR 129.35(a)(2) Operations water location, quality The operations water supply was not [properly located, protected, and operated] [easily accessible] [adequate] [of a safe, sanitary quality][in conformance at all times with applicable laws and regulations]. Specifically, *** 1
1351 21 CFR 129.35(a)(3)(i) Sample frequency - product water You did not take and analyze samples of product water [as often as necessary] [at least once every year for chemical contamination] [at least once every four years for radiological contaminants]. Specifically, *** 1
1364 21 CFR 129.35(a)(3)(ii) Analytical methods - recognized, approved The [test] [sample] methods for source water [were not recognized and approved by the government agency or agencies having approval over the water source] [were not consistent with the minimum requirements established in the quality standard for bottled water]. Specifically, *** 1
1374 21 CFR 129.35(a)(3)(iii) Analysis - competent commercial lab Analysis of [product] [operations] source water samples was not [always] performed for the plant by competent commercial laboratories. Specifically, *** 1
1412 21 CFR 129.37(b) Multiservice containers, utensils - transport, storage After cleaning, you did not transport or store all multiservice containers, utensils, or disassembled piping and equipment in a manner [that assured drainage] [that protected from contamination]. Specifically, *** 1
1415 21 CFR 129.37(c) Single service containers, caps, seals - sanitary closure Your single-service containers, caps, or seals were not [purchased] [stored] in sanitary closures. Specifically, *** 1
1453 21 CFR 129.40(a)(1) Suitability - equipment, utensils Plant equipment or utensils were not suitable for their intended use. Specifically, *** 1
1467 21 CFR 129.40(a)(2) Suitability - product water contact surfaces Product water contact surfaces were not constructed of nontoxic and nonabsorbent material [that can be adequately cleaned and sanitized] [that complies with the requirements for food additives]. Specifically, *** 1
1485 21 CFR 113.87(a) Scheduled processes not available Scheduled processes were not readily available to the [retort or processing system supervisor] [FDA Investigator]. Specifically, *** 1
1499 21 CFR 113.89 No corrective action taken No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a deviation from the scheduled process was found. Specifically, *** 1
1532 21 CFR 113.100(a)(7) 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, *** 1
1643 21 CFR 113.100(c) 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, *** 1
1645 21 CFR 113.100(c) 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, *** 1
1652 21 CFR 113.40(a)(1) Defective thermometer A retort was used without replacing or repairing a mercury-in-glass thermometer [with a divided column] [that could not be adjusted to the standard]. Specifically, *** 1
1665 21 CFR 110.80(a)(2) 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, *** 1
1706 21 CFR 110.80(b)(10) Mechanical manufacturing control Failure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, *** 1
1733 21 CFR 113.40(a)(2) Scale The working scale of the temperature-recording device chart was more than 55 degrees F per inch, within a range of 20 degrees F of the processing temperature. Specifically, *** 1
1735 21 CFR 113.40(a)(2) Unauthorized adjustment There was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, *** 1
1752 21 CFR 113.40(a)(8) Location - from ends Bleeders on horizontal retorts are not installed [approximately one foot from the outermost end at both ends of the retort] [on top of the retort]. Specifically, *** 1
1755 21 CFR 113.40(a)(8) Vertical retort - opposite steam inlet Failure to install at least one bleeder in the vertical retort in that portion of the retort opposite the steam inlet. Specifically, *** 1
1761 21 CFR 129.80(a) Records - equipment inspection You did not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the [type and date of physical inspections of equipment] [conditions found] [performance and effectiveness of equipment]. Specifically, *** 1
1764 21 CFR 129.80(b)(1) Multiservice primary containers - clean You did not adequately [clean] [sanitize] [inspect] multiservice primary containers just prior to the containers being filled, capped, and sealed. Specifically, *** 1
1812 21 CFR 129.80(c) Sample, test - cleaning, sanitizing solutions You did not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, *** 1
1853 21 CFR 113.40(a)(9) Suitable material Crates, trays, gondolas, etc., for holding containers are not made of strap iron, adequately perforated sheet metal, or other suitable material. Specifically, *** 1
1855 21 CFR 113.40(a)(12) Installation Vents are not installed so as to provide complete removal of air from a retort before the process start time. Specifically, *** 1
1865 21 CFR 113.40(a)(12) Short vent Timing of a process began before the retort [was properly vented] [processing temperature was reached]. Specifically, *** 1
2102 21 CFR 113.40(a)(13)(i) Maximum weight The [maximum fill-in weight] [drain weight] specified in the scheduled process is not [measured] [recorded] at intervals of sufficient frequency to ensure that the weight of the product is within limits specified in the scheduled process. Specifically, *** 1
2104 21 CFR 113.40(a)(13)(iii) 15 minute interval (S) Failure to make measurements and recordings of critical factors specified in the scheduled process at intervals not to exceed 15 minutes. Specifically, *** 1
2111 21 CFR 113.40(b)(4) Steam controller Failure to equip a retort with an automatic steam controller to maintain retort temperatures. Specifically, *** 1
2144 21 CFR 113.40(b)(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, *** 1
2206 21 CFR 113.40(b)(14) Measured, recorded Critical factors were not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors were within limits specified in the scheduled process. Specifically, *** 1
2208 21 CFR 113.40(b)(14)(ii) Closing vacuum Closing machine vacuum was not [observed] [recorded] at intervals of sufficient frequency to ensure that the vacuum was as specified in the scheduled process. Specifically, *** 1
2273 21 CFR 129.80(g)(1) Representative samples - bottled water Samples collected for [bacteriological] [chemical] [physical] [radiological] analysis were not primary containers or unit packages from a batch or segment of a continuous production run for each type of bottled drinking water. Specifically, *** 1
2284 21 CFR 129.80(f) Inspection - filled containers You did not visually or electronically inspect filled containers to assure they are [sound] [properly capped or sealed] [properly coded and labeled]. Specifically, *** 1
2367 21 CFR 129.80(a) Effective treatment - product water Your treatment of product water was not done in a manner that was effective in accomplishing the intended purpose. Specifically, *** 1
2390 21 CFR 110.80(a)(6) Kept frozen prior to use Failure to keep frozen raw materials frozen prior to use. Specifically, *** 1
2391 21 CFR 110.80(a)(6) Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, *** 1
2438 21 CFR 113.40(c)(8)(i) Cans in valves Following an emergency stop of the retort, containers in the in-take valve or transfer valves between cooker shells were not reprocessed, repacked and reprocessed, or discarded. Specifically, *** 1
2439 21 CFR 113.40(c)(8)(ii) Time of stop Failure to note on the [recording chart] [production record] the time at which the reel stopped following a malfunction. Specifically, *** 1
2552 21 CFR 113.40(f)(8) Unauthorized changes There is no means of preventing unauthorized speed changes on retorts Specifically, *** 1
2844 21 CFR 113.40(g)(1)(i)(b) Presence and accuracy Each product sterilizer was not equipped with an accurate temperature-recording device. Specifically, *** 1
2848 21 CFR 113.40(g)(1)(i)(b) 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, *** 1
2849 21 CFR 113.40(g)(1)(i)(b) Unauthorized adjustment There is no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, *** 1
2860 21 CFR 113.40(g)(1)(i)(f) Unauthorized speed changes There was no means of preventing unauthorized speed changes to the metering pump. Specifically, *** 1
2864 21 CFR 113.40(g)(1)(ii)(b) Process deviations per 113.89 Process deviations are not handled in accordance with 21 CFR 113.89. Specifically, *** 1
2885 21 CFR 113.40(i) Methods and controls operated and administered for safety Methods and controls used for the manufacturing, processing and packaging of thermally processed foods wherein critical factors such as water activity are used are not operated and administered in a manner adequate to ensure the product is safe. Specifically, *** 1
2899 21 CFR 113.40(g)(2)(ii)(c) 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, *** 1
3068 21 CFR 114.80(a)(1) pH control Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain] a pH value of 4.6 or lower in all finished foods. Specifically, *** 1
3091 21 CFR 114.100(e) 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, *** 1
3092 21 CFR 114.89 Process deviation - disposition Failure to fully reprocess or destroy food where a process deviation has been evaluated as being unsafe. Specifically, *** 1
15617 21 CFR 111.180(a) Records - comp, package, labels, product received: Available You did not have records or copies of records required for [components] [packaging] [labels] [product received for packaging or labeling] readily available during the required retention period for inspection and copying by FDA when requested. Specifically, *** 1
15618 21 CFR 111.180(b)(1) Written procedures - components You did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements. Specifically, *** 1
15619 21 CFR 111.180(b)(1) 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, *** 1
15620 21 CFR 111.180(b)(1) Written procedures - product received You did not make and keep written procedures for fulfilling the requirements that apply to product received for packaging or labeling as a dietary supplement and for distribution rather than for return to the supplier. Specifically, 1
15627 21 CFR 111.180(b)(3) Documentation - product received; packaging, labeling You did not make and keep documentation that the requirements that apply to production and process control for product received for packaging or labeling as a dietary supplement were met. Specifically, *** 1
15634 21 CFR 111.180(b)(3)(ii)(D) Documentation - required operation; material review, disposi Your documentation of a required operation did not include a material review and disposition decision conducted on components, packaging, labels, or products that you received for packaging or labeling as a dietary supplement. Specifically, *** 1
3644 21 CFR 110.10(b)(5) Impermeable (S) Gloves used for food handling are not impermeable. Specifically, *** 1
3649 21 CFR 110.35(d)(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, *** 1
3650 21 CFR 110.35(d)(1) Wet cleaning Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned. Specifically, *** 1
3708 21 CFR 110.80(a)(1) Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, *** 1
3773 21 CFR 113.40(a)(7) Number and size of steam spreader perforations (S) The total cross-sectional area of steam spreader perforations is [less than 1 1/2] [greater than 2] times the cross-sectional area of the smallest restriction in a steam inlet line. Specifically, *** 1
3800 21 CFR 113.40(a)(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, *** 1
3821 21 CFR 113.40(g)(1)(i)(a) Date of last calibration Failure to provide a tag, seal, or other means of identifying the date of last calibration of the temperature-indicating device. Specifically, *** 1
3859 21 CFR 113.60(a) 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, *** 1
3860 21 CFR 113.60(a) Pertinent observations Failure to record all pertinent visual closure observations. Specifically, *** 1
3862 21 CFR 113.60(a)(1) Failure to perform teardown examinations Failure to [have a qualified individual] perform teardown examinations of double seam cans . Specifically, *** 1
3863 21 CFR 113.60(a)(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, *** 1
3868 21 CFR 113.60(a)(1)(ii) Method of taking seam measurements (seam scope) Failure to measure can double seam characteristics using a seam [projector] [scope] at two different locations, excluding the side seam. Specifically, *** 1
3870 21 CFR 113.60(a)(2) Glass containers, capper efficiency check Failure to measure the cold water vacuum of the glass container capper before actual filling operations. Specifically, *** 1
3875 21 CFR 113.60(b) Cooling water - residual sanitizer (S) No measurable residual of the cooling water sanitizer at the water discharge point of the container cooler. Specifically, *** 1
4421 21 CFR 110.20(a) Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, *** 1
4516 21 CFR 108.35(c)(2)(i) Limited process filing Failure to provide FDA with existing information as to the scheduled process and request an extension of time for submission of the additional information. Specifically, *** 1
4520 21 CFR 108.35(c)(3)(ii) Process information availability Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, *** 1
4528 21 CFR 108.35(c)(2)(ii) 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, *** 1
4530 21 CFR 114.100(c) Process deviations - product disposition Failure to record the disposition of product involved in a departure from a scheduled process. Specifically, *** 1
9919 21 CFR 120.10(a) 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, *** 1
9929 21 CFR 120.12(b)(4) Records - information not entered when observed Processing and other information is not [always] entered on your records at the time it is observed. Specifically, *** 1
9938 21 CFR 120.7(d) 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, *** 1
9960 21 CFR 120.12(d)(2) Records - offsite storage - not returned for review You did not retrieve and provide records stored offsite within 24 hours of request for official review. Specifically, *** 1
12709 21 CFR 129.80(c) Records - cleaning, sanitizing solutions You did not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, *** 1
12715 21 CFR 129.80(f) Bacteriological tests - competent lab Bacteriological tests were not performed by either qualified plant personnel or a competent commercial laboratory. Specifically, *** 1
12733 21 CFR 120.11(a)(1)(iv)(C) 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, *** 1
15305 21 CFR 120.14(a)(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, *** 1
15358 FDCA 761(c)(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, *** 1
15388 21 CFR 111.10(b) 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, *** 1
15391 21 CFR 111.10(b)(3) 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, *** 1
15395 21 CFR 111.10(b)(5) Gloves Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material]. Specifically, *** 1
15396 21 CFR 111.10(b)(6) Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner]. Specifically, *** 1
15405 21 CFR 111.13(a) Supervisor - qualified You have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling] [holding] of dietary supplements]. Specifically, *** 1
15411 21 CFR 111.14(b)(2) Personnel - records - training date, type, persons Your training documentation did not include the [date of the training] [type of training] [persons trained]. Specifically, *** 1
15428 21 CFR 111.15(h) Bathrooms - clean Your bathrooms [were not clean] [were a potential source of contamination to components, dietary supplements, or contact surfaces]. Specifically, *** 1
15429 21 CFR 111.15(k) Sanitation supervisors - assigned You did not assign one or more employees to supervise overall sanitation. Specifically, *** 1
15431 21 CFR 111.15(e)(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, *** 1
15433 21 CFR 111.15(d)(1) Animals and pests in facility You allowed [animals] [pests] in your physical plant. Specifically, *** 1
15437 21 CFR 111.15(a)(1) Grounds - equipment, litter, weeds You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant. Specifically, *** 1
15445 21 CFR 111.15(c)(1) Sanitizing agents You did not use sanitizing agents that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use]. Specifically, *** 1
15456 21 CFR 111.20(b) 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, *** 1
15459 21 CFR 111.20(d) Physical plant - design and construction Your physical plant was not [designed] [constructed] in a manner that prevents contamination of components, dietary supplements, or contact surfaces. Specifically, *** 1
15462 21 CFR 111.20(d)(1)(iv) Physical plant - temperature, humidity controls Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement. Specifically, *** 1
15482 21 CFR 111.23(c) 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, *** 1
15502 21 CFR 111.27(a)(3)(ii) Equipment - corrosion-resistant Your equipment or utensils that contact components or dietary supplements are not corrosion-resistant. Specifically, *** 1
15504 21 CFR 111.27(a)(3)(iv) Equipment - withstand environment Your equipment or utensils are not designed or constructed to withstand [the environment in which they are used] [the action of components or dietary supplements] [cleaning compounds and sanitizing agents]. Specifically, *** 1
15511 21 CFR 111.27(d) 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, *** 1
15527 21 CFR 111.30(c) Equipment - automated - QC check Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of your automated, mechanical, or electronic equipment. Specifically, *** 1
15529 21 CFR 111.30(e) 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, *** 1
15535 21 CFR 111.255(d) Batch record - 1 year, 2 years "You did not keep batch production records for the required time period. Specifically, ***" 1
15537 21 CFR 111.255(d) Batch record - electronic Your electronic batch production records do not comply with the electronic records requirements. Specifically, *** 1
15562 21 CFR 111.260(l)(1) Batch record - quality control review; production Your batch production records did not include documentation that quality control personnel reviewed the batch production record. Specifically, *** 1
15563 21 CFR 111.260(l)(1)(i) Batch record - quality control review; monitoring Your batch production records did not include documentation that quality control personnel reviewed required monitoring operations. Specifically, *** 1
15573 21 CFR 111.153 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, *** 1
15574 21 CFR 111.153 Written procedures - rejected components, packaging, labels You did not [establish] [follow] written procedures for the requirements for rejected components, packaging, or labels. Specifically, *** 1
15581 21 CFR 111.155(c)(3) Quality control - components, approve, release Your quality control personnel did not [approve components while the components were quarantined] [release components from quarantine] for use in the manufacture of a dietary supplement. Specifically, *** 1
15585 21 CFR 111.155(d)(2) Components - unique identifier You did not use a unique identifier whenever you recorded the disposition of [each unique lot within each unique shipment of components that you received] [each lot of components that you produced]. Specifically, *** 1
15591 21 CFR 111.160(c)(1) Labels - quarantine; samples You did not collect representative samples of labels while the labels were quarantined. Specifically, *** 1
15606 21 CFR 111.165(c)(1) Product received - quarantine; representative samples You did not collect representative samples of received product while the received product was quarantined. Specifically, *** 1
15607 21 CFR 111.165(c)(2) 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, *** 1
15643 21 CFR 111.455(b) Hold - adversely affected You did not hold [packaging] [labels] under appropriate conditions so that [it was not] [they were not] adversely affected. Specifically, *** 1
15646 21 CFR 111.460(a) 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, *** 1
15648 21 CFR 111.465(a)(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, *** 1
15653 21 CFR 111.470 Distribute dietary supplement; contamination, deterioration You did not distribute a dietary supplement under conditions that protect the dietary supplement against contamination and deterioration. Specifically, *** 1
15656 21 CFR 111.475(a) Records-holding, distribution: originals, copies, electronic You did not keep the records required for your holding and distributing operations as original records, true copies, or as electronic records. Specifically, *** 1
15669 21 CFR 111.310(c) 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, *** 1
15671 21 CFR 111.315 Laboratory control processes - requirements You did not [establish] [follow] laboratory control processes. Specifically, *** 1
15689 21 CFR 111.315(b)(3) Sampling plans; finished batches You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of dietary supplements. Specifically, *** 1
15698 21 CFR 111.320(a) Examination, testing; appropriate You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use. Specifically, *** 1
15708 21 CFR 111.325(a) Written procedures, laboratory operations You did not make and keep written procedures for laboratory operations. Specifically, *** 1
15710 21 CFR 111.325(b)(2)(i) Document; laboratory methodology followed The person who conducted the testing and examination did not document [at the time of performance] that established laboratory methodology was followed. Specifically, *** 1
15718 21 CFR 111.375(a) Records-manufacturing operation:originals,copies,electronic You did not keep the records required for manufacturing operations as original records, true copies, or as electronic records. Specifically, *** 1
15720 21 CFR 111.370 Rejected dietary supplements - identify, hold, control You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations. Specifically, 1
15735 21 CFR 111.355 Manufacturing operations - design You did not design or select manufacturing processes that ensure that product specifications are consistently met. Specifically, *** 1
15739 21 CFR 111.210(h)(3)(ii)(B) Components; add, verify The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person to add and another person to verify the addition of the components. Specifically, *** 1
15740 21 CFR 111.210(h)(3)(ii)(A) Instructions; components; weight, measure The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person weighing or measuring and another person verifying the weight or measure of components. Specifically, *** 1
15743 21 CFR 111.210(h)(3) 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, *** 1
15751 21 CFR 111.210(d) Master manufacturing record - Supplemental Facts Your master manufacturing record did not include the [identity] [weight or measure] of each dietary ingredient that will be declared on the Supplement Facts label. Specifically, *** 1
15754 21 CFR 111.210(a) 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, *** 1
15765 21 CFR 111.430(a) Packaging, labeling operations:originals, copies, electronic You did not keep the records required for your packaging and labeling operations as original records, true copies, or as electronic records. Specifically, *** 1
15771 21 CFR 111.415(h) 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, *** 1
15772 21 CFR 111.415(g) Representative sample - packaged, labeled dietary supplement You did not examine a representative sample of each batch of packaged and labeled dietary supplement to determine whether the dietary supplement meets established specifications. Specifically, *** 1
15775 21 CFR 111.415(e) Dietary supplement containers - mix-ups 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, *** 1
15776 21 CFR 111.415(d) 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, *** 1
15777 21 CFR 111.415(c) Filling, assembling, packaging, labeling - sanitary handling You did not use sanitary handling procedures during [filling] [assembling] [packaging] [labeling] operations. Specifically, *** 1
15780 21 CFR 111.415 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, *** 1
15803 21 CFR 111.560© Product complaint -investigate, findings, follow-up Your [review about whether to investigate a product complaint] [findings and follow-up action of an investigation performed] did not extend to all relevant batches and records. Specifically, *** 1
15805 21 CFR 111.570(a) Records - product complaints: 1 year, 2 years You did not keep the records required for product complaints for the required time period. Specifically, *** 1
15808 21 CFR 111.570(a) Records - product complaints: readily available You did not have records or copies of records required for product complaints readily available during the required retention period for inspection and copying by FDA when requested. Specifically, *** 1
15815 21 CFR 111.570(b)(2)(ii)(D) Record - product complaint; nature, how used The written record of a product complaint did not include the nature of the complaint. Specifically, *** 1
15816 21 CFR 111.570(b)(2)(ii)(E) Record - product complaint; reply The written record of a product complaint did not include the reply to the complainant. Specifically, *** 1
15822 21 CFR 111.60(a) Production, in- process control system design, master record Your production and in-process control system is not designed to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, *** 1
15826 21 CFR 111.65 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, *** 1
15845 21 CFR 111.73 Specifications met - quality You did not determine whether you met specifications established to ensure the quality of the dietary supplement. Specifically, *** 1
15852 21 CFR 111.73 Specifications met - labels, packaging You did not determine whether you met established specifications for [dietary supplement labels] [packaging that may come in contact with dietary supplements]. Specifically, *** 1
15863 21 CFR 111.75(a)(2)(ii)(B) Component - certificate of analysis The certificate of analysis for a component does not include [a description of the test or examination method(s) used] [limits of the test or examination] [actual results of the tests or examinations]. Specifically, *** 1
15875 21 CFR 111.75(d)(1) Documentation specifications met; exempted, periodic testing You did not document why an exempted product specification is met without verification by periodically testing the finished batch. Specifically, *** 1
15878 21 CFR 111.75(e) 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, *** 1
15880 21 CFR 111.75(f)(2) Label - visual examination, review supplier's documentation You did not [conduct a visual examination of the label] [review the supplier's invoice, guarantee, or certification] to determine whether label specifications are met. Specifically, *** 1
15886 21 CFR 111.77(b) Specifications not met - identity; component, reject Your quality control personnel did not reject a component that did not meet an identity specification. Specifically, *** 1
15898 21 CFR 111.83(b)(1) Reserve sample -container-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, *** 1
15899 21 CFR 111.83(b)(1) 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, *** 1
15908 21 CFR 111.90(b)(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, *** 1
15920 21 CFR 111.95(b)(1) Records - established specifications You did not make and keep records of established specifications. Specifically, *** 1
15931 21 CFR 111.105 Quality control - packaged, labeled Your quality control personnel did not ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, *** 1
15934 21 CFR 111.105(c) 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, *** 1
15939 21 CFR 111.105(g) Quality control - reserve samples Your quality control personnel did not ensure that required reserve samples were collected and held. Specifically, *** 1
15942 21 CFR 111.105(i) QC- required operations equipment, instruments, controls Your quality control personnel did not perform required operations for [equipment] [instruments] [controls]. Specifically, *** 1
15945 21 CFR 111.105(i) QC - required operations packaging/labeling operations Your quality control personnel did not perform required operations for [packaging] [labeling] operations. Specifically, *** 1
15946 21 CFR 111.105(i) QC - required operations returned dietary supplements Your quality control personnel did not perform required operations for returned dietary supplements. Specifically, *** 1
15948 21 CFR 111.110 Quality control operations - laboratory operations You do not have quality control operations for laboratory operations associated with the production and process control system. Specifically, *** 1
15950 21 CFR 111.110(b) Quality control operations - tests, examinations Your quality control operations did not include ensuring that [tests] [examinations] required for your laboratory operations were conducted. Specifically, *** 1
15951 21 CFR 111.110(c) Quality control operations - tests, examinations; results Your quality control operations did not include reviewing and approving the results of required [tests] [examinations]. Specifically, *** 1
15957 21 CFR 111.113(a)(4) QC- calibration; quality; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision when calibration of an instrument or control suggested a problem that may have resulted in a failure to ensure the quality of [a batch] [batches] of a dietary supplement. Specifically, *** 1
15967 21 CFR 111.117(b) Quality control operations - calibration records Your quality control operations did not include periodically reviewing all records for calibration of instruments and controls. Specifically, *** 1
15980 21 CFR 111.123(a)(4) QC operations - material review, disposition decision Your quality control operations for [the master manufacturing record] [the batch production record] [manufacturing operations] did not include conducting a required material review and making a required disposition decision. Specifically, *** 1
15981 21 CFR 111.123(a)(5) Quality control operations - reprocessing Your quality control operations did not include approving or rejecting reprocessing. Specifically, *** 1
15982 21 CFR 111.123(a)(6) Quality control operations - in-process specifications Your quality control operations did not include determining whether established in-process specifications were met. Specifically, *** 1
15983 21 CFR 111.123(a)(7) Quality control operations - finished batch, specifications Your quality control operations did not include determining whether each finished batch conforms to established product specifications. Specifically, *** 1
15987 21 CFR 111.123(b)(3) Quality control - batch released, adulteration Your quality control personnel approved and released for distribution a batch of dietary supplement that was not manufactured, packaged, labeled, or held under conditions to prevent adulteration. Specifically, *** 1
15991 21 CFR 111.127(a) Quality control operations - labeling; visual examinations Your quality control operations for labeling did not include reviewing the results of [visual examinations] [documentation] to ensure that established specifications were met for products that you receive for labeling. Specifically, *** 1
15995 21 CFR 111.127(d) 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, *** 1
16003 21 CFR 111.130(a)(2) Returned dietary supplement; tests, examinations; results Your quality control operations for returned dietary supplements did not include reviewing the results of any tests or examinations conducted to determine compliance with product specifications. Specifically, *** 1
16008 21 CFR 111.135 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, *** 1
16017 21 CFR 111.140(b)(3) Records - material review, disposition You did not make and keep documentation of your material review and disposition decision. Specifically, *** 1
16037 21 CFR 111.605 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, *** 1
16044 21 CFR 111.503 Written procedures - returned dietary supplement; salvaged You did not [establish] [follow] written procedures for when a returned dietary supplement may be salvaged. Specifically, *** 1
16046 21 CFR 111.503 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, *** 1
16047 21 CFR 111.510 Returned dietary supplement - material review, disposition You did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision. Specifically, *** 1
16049 21 CFR 111.520 Returned dietary supplement - salvaged You salvaged a returned dietary supplement for which quality control personnel did not conduct a material review and make a disposition decision to allow the salvage. Specifically, *** 1
16059 21 CFR 111.535(b)(3) Returned dietary supplement: results; testing, examination You did not make and keep records of the results of testing or examination conducted to determine compliance with established product specifications. Specifically, *** 1
16065 21 CFR 111.35(b)(1) Written procedures - equipment, utensils; make, keep You did not make and keep written procedures for fulfilling the requirements for equipment and utensils. Specifically, *** 1
16068 21 CFR 111.35(b)(1)(iii) 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, *** 1
16069 21 CFR 111.35(b)(1)(iii) Procedures contact surfaces; maintaining, cleaning, sanitize You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Specifically, *** 1
16083 21 CFR 111.35(b)(6) 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, *** 1
16085 21 CFR 111.75(c)(3) Specifications met limits on contamination ; basis You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for the limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement will ensure that the finished batch of dietary supplement will not be adulterated as a result of such contamination. Specifically, *** 1
16087 21 CFR 111.123(b)(4) QC supplier product released assurance not provided package Your quality control personnel approved and released for distribution product received from a supplier for [packaging] as a dietary supplement for which sufficient assurance was not provided [to adequately identify the product] [to determine that the product was consistent with your purchase order]. Specifically, *** 1
16144 21 CFR 118.4(d) Before new laying hens added Your poultry house was not cleaned and disinfected by appropriate procedures before new laying hens were added to the house, when there was [an environmental test] [an egg test] that was positive for SE at any point during the life of a flock that was housed there prior to depopulation. Specifically,*** 1
16153 21 CFR 118.5(a)(1) Poultry house has multiple groups of laying hens Environmental testing for SE, using approved methods, was not done in a poultry house containing more than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age. Specifically,*** 1
16156 21 CFR 118.5(b) Environmental testing after induced molting period Environmental testing of SE in a poultry house was not performed at 4 to 6 weeks after the end of the molting process which followed your inducing of a molt in a flock or a group in the flock. Specifically,*** 1
16157 21 CFR 118.5(b)(1) SE testing 4 to 6 weeks after each molting process You did not perform environmental testing for SE 4 to 6 weeks after the end of the molting process each time a flock or group within the flock was molted. Specifically*** 1
16162 21 CFR 118.6(a)(2) SE positive test any time during life of flock An environmental test during the life of a flock was positive for SE, and you failed to divert eggs for treatment for the life of the flock or conduct egg testing as required. Specifically,*** 1
16185 21 CFR 118.9 Supervisor duties You lack [qualified] supervisory personnel who are responsible for [development and implementation of an SE plan that is appropriate for your farm and meets the regulatory requirement] [reassessing and modifying the SE prevention plan as necessary] [reviewing records created to document the SE prevention measures]. Specifically, *** 1
16189 21 CFR 118.10(c) Records retention time All records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production. Specifically,*** 1
16196 21 CFR 118.10(a)(3)(v) Sampling procedures documentation You did not maintain records documenting compliance with environmental and egg sampling procedures. Specifically,*** 1
16197 21 CFR 118.10(a)(3)(vi) SE testing results documentation You did not maintain records documenting the results of SE testing. Specifically,*** 1
16200 21 CFR 118.10(d) Offsite storage of records except SE plan Your written SE prevention plan was stored offsite. Specifically,*** 1
16201 21 CFR 118.10(d) 24 hour retrieval of offsite records You are not able to retrieve and provide the records at your place of business within 24 hours of request for official review. Specifically,*** 1
16202 21 CFR 118.10(e) Official review and copying of records You did not have all records required available for [official review] [copying] at reasonable times. Specifically,*** 1
16241 21 CFR 118.12(b) Refusal to permit inspection You refused to permit authorized representatives of FDA to make an inspection, at a reasonable time, of your egg production establishment in which shell eggs were being produced. Specifically,*** 1
16493 FDCA 601(b) Contamination with filth Your cosmetic consists in whole or in part of any filthy, putrid, or decomposed substance. Specifically, *** 1
16500 21 CFR 129.35(a)(3)(i) E. coli follow-up, eliminate, prevent reoccurrence You did not take appropriate measures to rectify or otherwise eliminate the cause of Escherichia coli contamination of your [product] [operations] source water [in a manner sufficient to prevent its reoccurrence]. Specifically, *** 1
Cite Id Ref No Short Description Long Description Frequency
3130 21 CFR 820.100(a) Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** 360
14713 21 CFR 820.198(a) Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,*** 251
479 21 CFR 820.50 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, *** 129
546 21 CFR 820.75(a) 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, *** 122
630 21 CFR 803.17 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, *** 117
3696 21 CFR 820.100(b) Documentation Corrective and preventive action activities and/or results have not been [adequately] documented. Specifically, *** 101
3282 21 CFR 820.90(a) Nonconforming product, Lack of or inadequate procedures Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, *** 100
3103 21 CFR 820.30(i) Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established. Specifically,*** 95
2327 21 CFR 820.22 Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been [adequately] established. Specifically, *** 90
3172 21 CFR 820.198(c) 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, *** 68
2350 21 CFR 820.25(b) Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, *** 61
14722 21 CFR 820.40 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained]. Specifically,*** 61
3666 21 CFR 820.20(c) Management review - Lack of or inadequate procedures Procedures for management review have not been [adequately] established. Specifically,*** 60
3331 21 CFR 820.181 DMR - not or inadequately maintained A device master record has not been [adequately] maintained. Specifically, *** 58
3125 21 CFR 820.80(d) Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been [adequately] established. Specifically, *** 55
3680 21 CFR 820.70(a) 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, *** 55
2371 21 CFR 820.30(a) Design control - no procedures Procedures for design control have not been established. Specifically,*** 53
3678 21 CFR 820.30(g) Design Validation - Risk analysis not performed/inadequate Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, *** 48
732 21 CFR 803.50(a)(2) 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, *** 47
3120 21 CFR 820.80(a) Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established. Specifically,*** 46
3101 21 CFR 820.30(g) Design validation- Lack of or inadequate procedures Procedures for design validation have not been [adequately] established. Specifically,*** 45
3118 21 CFR 820.75(a) Documentation Process validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved]. Specifically, *** 45
3121 21 CFR 820.80(b) Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been [adequately] established. Specifically, *** 44
541 21 CFR 820.70(c) Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been [adequately] established. Specifically, *** 43
3104 21 CFR 820.30(j) 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]. 43
3233 21 CFR 820.72(a) Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically, *** 42
14712 21 CFR 820.184 DHR - not or inadequately maintained A device history record has not been [adequately] maintained. Specifically, *** 42
3159 21 CFR 820.184 DHR content "The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820]. " 41
447 21 CFR 820.40 Lack of procedures, or not maintained Document control procedures have not been [established] [maintained]. Specifically,*** 39
3837 21 CFR 820.25(b) Training records Personnel training is not documented. Specifically, *** 38
3415 21 CFR 820.22 Quality Audit/Reaudit - conducted Quality [audits][reaudits] have not been performed. Specifically, *** 37
3669 21 CFR 820.20(c) 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, *** 37
2974 21 CFR 812.110(b) 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, *** 33
3286 21 CFR 820.90(b)(1) 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, *** 33
731 21 CFR 803.50(a)(1) 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, *** 32
3168 21 CFR 820.198(a) Complaints Complaint files are not [adequately] maintained. Specifically *** 32
537 21 CFR 820.70(a) Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications. Specifically, *** 31
3128 21 CFR 820.90(a) Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, *** 30
3160 21 CFR 820.184 Lack of or inadequate DHR procedures Procedures for device history records have not been [adequately] established. Specifically,*** 30
3375 21 CFR 820.198(e) Records of complaint investigation Records of complaint investigations do not include required information. Specifically, *** 29
3127 21 CFR 820.80(e) 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, *** 28
2604 21 CFR 820.30(e) Design review - Lack of or inadequate procedures Procedures for design review have not been [adequately] established. Specifically,*** 27
3119 21 CFR 820.75(b) 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, *** 27
4059 21 CFR 820.22 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, *** 27
419 21 CFR 820.20(b) 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, *** 26
486 21 CFR 820.50(a) Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, *** 26
3263 21 CFR 820.250(b) Sampling plans Sampling plans are not [written][based on valid statistical rationale]. Specifically, *** 23
14716 21 CFR 820.30(f) Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements. Specifically, *** 23
2302 21 CFR 820.20(e) Quality System Procedures Quality system procedures and instructions have not been established. Specifically,*** 22
3117 21 CFR 820.70(i) 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, *** 22
3132 21 CFR 820.120 Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been [adequately] established. Specifically, *** 22
14505 21 CFR 812.140(a)(3) Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current]. Specifically, *** 22
2650 21 CFR 820.30(f) Design verification - Lack of or inadequate procedures Procedures for design verification have not been [adequately] established. Specifically,*** 21
3226 21 CFR 820.70(g)(1) Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, *** 20
3102 21 CFR 820.30(h) Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been [adequately] established. Specifically,*** 19
3207 21 CFR 820.50(b) Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, *** 19
3285 21 CFR 820.90(b)(2) Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been [adequately] established. Specifically, *** 19
14720 21 CFR 820.50(a)(3) Acceptable supplier records, inadequate records Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established. 19
539 21 CFR 820.70(b) Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, *** 18
631 21 CFR 803.17(a)(1) 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, *** 18
2328 21 CFR 820.22 Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, *** 18
3192 21 CFR 820.30(g) Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses. Specifically, *** 18
4070 21 CFR 820.30(g) 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, *** 18
3170 21 CFR 820.198(b) Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, *** 17
2557 21 CFR 820.30(c) Design input - documentation Design input requirements were not [adequately] documented. Specifically, *** 16
2968 21 CFR 812.100 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, *** 16
3426 21 CFR 820.50(a)(1) Documented evaluation The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, *** 16
4191 21 CFR 806.10(a)(1) 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, *** 16
14714 21 CFR 820.30(c) Design input - Lack of or inadequate procedures Procedures for design input have not been [adequately] established. Specifically,*** 16
3235 21 CFR 820.72(a) Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, *** 15
3123 21 CFR 820.80(c) Lack of or inadequate In-process acceptance procedures Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, *** 14
3427 21 CFR 820.50(a)(2) Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, *** 14
14710 21 CFR 820.150 Lack of or inadequate procedures for storage. Procedures for the control of storage areas and stock rooms have not been [adequately] established. Specifically,*** 14
502 21 CFR 820.60 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, *** 13
2293 21 CFR 820.20(d) Quality plan A quality plan has not been [adequately] established. Specifically, *** 13
3262 21 CFR 820.250(a) 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,*** 13
3425 21 CFR 820.50(a)(1) Evaluation and Selection, Suppliers, Contractors, etc. Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, *** 13
3201 21 CFR 820.40(a) 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, ***" 12
3433 21 CFR 820.75(c) Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, *** 12
3671 21 CFR 820.25(a) Personnel Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, *** 12
632 21 CFR 803.17(a)(2) 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, *** 11
2984 21 CFR 812.140(a)(3)(i) 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, *** 11
3108 21 CFR 820.70(e) 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, *** 11
3676 21 CFR 820.30(f) 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, *** 11
3686 21 CFR 820.90(b)(2) Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, *** 11
2981 21 CFR 812.140(a)(2)(i) 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, *** 10
3270 21 CFR 820.80(c) Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, *** 10
3310 21 CFR 820.120(b) 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, *** 10
2269 21 CFR 820.20(a) Quality policy and objectives The [quality policy] [quality objectives] was/were not established by management with executive responsibility. Specifically, *** 9
2970 21 CFR 812.100 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, *** 9
3173 21 CFR 820.198(d) 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, *** 9
3432 21 CFR 820.75(b)(2) 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, *** 9
3668 21 CFR 820.20(c) Management review dates The results and/or dates of management reviews are not documented. Specifically, *** 9
3190 21 CFR 820.30(g) Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities. Specifically, *** 8
3199 21 CFR 820.40(a) Document review, approval documentation The documentation of approval of documents does not include [the document approval date] [the signature of the approving official]. Specifically, *** 8
3204 21 CFR 820.40(b) 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, ***" 8
3231 21 CFR 820.70(i) 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, *** 8
454 21 CFR 820.40(a) Document review, approval by designated individual Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance . Specifically, *** 7
2430 21 CFR 820.30(b) Design plans - Lack of or inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established. Specifically, *** 7
2630 21 CFR 820.30(e) Design review - documentation The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file. Specifically, *** 7
2928 21 CFR 812.40 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, *** 7
3191 21 CFR 820.30(g) Design validation - production units The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, *** 7
3193 21 CFR 820.30(g) Design validation - simulated testing The design was not validated under actual or simulated use conditions. Specifically, *** 7
3206 21 CFR 820.50(b) 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, *** 7
3313 21 CFR 820.120(d) 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, *** 7
3677 21 CFR 820.30(g) Design validation - software validation not performed Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, *** 7
4212 21 CFR 806.20(b)(4) 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,*** 7
14715 21 CFR 820.30(d) Design output - Lack of or inadequate procedures Procedures for design output have not been [adequately] established. Specifically,*** 7
14718 21 CFR 820.30(g) Design validation - Risk analysis Results of the design risk analysis were not [adequately] documented. Specifically, *** 7
2980 21 CFR 812.140(a)(1) 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, *** 6
3109 21 CFR 820.70(d) Personnel requirements, Lack of or inadequate requirements Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing]. Specifically, *** 6
3175 21 CFR 820.186 QSR The quality system record has not been [adequately] maintained Specifically *** 6
3266 21 CFR 820.86 Acceptance status The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained]. Specifically, *** 6
3345 21 CFR 820.200(a) 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, *** 6
3674 21 CFR 820.30(d) Design output - documentation Design output was not [adequately] documented before release. Specifically, *** 6
14711 21 CFR 820.160(a) Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established. Specifically,*** 6
3149 21 CFR 820.180 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, *** 5
3232 21 CFR 820.72(a) Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically, *** 5
3269 21 CFR 820.80(b) Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented. Specifically, *** 5
3372 21 CFR 820.198(d) Records of MDR Investigation Investigation records of MDR reportable complaints do not include required information. Specifically *** 5
3409 21 CFR 820.200(d) Service reports Service reports [are not documented] [do not include the required information]. Specifically, *** 5
3434 21 CFR 820.75(c) 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, *** 5
4193 21 CFR 806.10(b) 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, *** 5
4208 21 CFR 806.20(a) Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,*** 5
7006 21 CFR 812.43(c)(5) 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, *** 5
7013 21 CFR 812.110(d) 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, *** 5
14717 21 CFR 820.30(g) Design validation - software validation documentation Results of the validation of the device software were not [adequately] documented. Specifically, *** 5
633 21 CFR 803.17(a)(3) 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, *** 4
812 21 CFR 803.56 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, *** 4
3147 21 CFR 820.170(a) Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established. Specifically,*** 4
3171 21 CFR 820.198(b) Rationale documented for no investigation Records for complaints where no investigation was made do not include required information. Specifically *** 4
3203 21 CFR 820.40(b) Document change records, maintained. Records of changes to documents were not [adequately] maintained. Specifically, *** 4
3224 21 CFR 820.70(g)(2) Periodic equipment inspection lack of or inadequate procedu Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established. Specifically, *** 4
3239 21 CFR 820.72(b) Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, *** 4
3682 21 CFR 820.70(d) Implementing Personnel Procedures, Health, Cleanliness. Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, *** 4
3683 21 CFR 820.70(g) 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, *** 4
14507 21 CFR 812.140(a)(3)(ii) Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current]. Specifically, *** 4
635 21 CFR 803.17(b)(1) 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, *** 3
733 21 CFR 803.50(b)(1) Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, *** 3
2338 21 CFR 820.22 Quality audit - audit report review Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically, *** 3
2949 21 CFR 812.46(a) 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, *** 3
2985 21 CFR 812.140(a)(3)(ii) 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, *** 3
3002 21 CFR 812.140(b)(5) Sponsor records of adverse device effects & complaints Records concerning [anticipated adverse device effects] [unanticipated adverse device effects] [complaint] reports are not all [accurate] [complete] [current]. Specifically, *** 3
3007 21 CFR 812.140(d) 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, *** 3
3236 21 CFR 820.72(b) Calibration procedures - content Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, *** 3
3237 21 CFR 820.72(b) 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, *** 3
3309 21 CFR 820.120(b) 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, *** 3
4057 21 CFR 820.20(a) 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, *** 3
4436 21 CFR 803.40(a) 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, *** 3
7012 21 CFR 812.100 Investigator lack of control of investigational devices Devices under investigation were not properly controlled. Specifically, *** 3
14511 21 CFR 812.2(b) Abbreviated requirements / non-significant risk study A clinical investigation that was determined to be a non-significant risk device study does not meet the abbreviated requirements for investigational device exemptions (IDEs). Specifically, *** 3
14721 21 CFR 820.70(g)(2) Periodic equipment inspections Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented]. Specifically, *** 3
512 21 CFR 820.65 Traceability Lack of or inadequate {see also 820.120(e)} Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been [adequately] established. Specifically, *** 2
2339 21 CFR 820.22 Quality Audit/Reaudit - documentation The dates of quality [audits][reaudits] have not been documented. Specifically, *** 2
2431 21 CFR 820.30(b) Design plans- updated Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, *** 2
2930 21 CFR 812.42 Sponsor began study before IRB/FDA approval [An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, *** 2
2933 21 CFR 812.43(a) Investigator(s) not qualified One or more investigators were selected who were not qualified by [training] [experience] to investigate a device. Specifically, *** 2
2946 21 CFR 812.45 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, *** 2
2969 21 CFR 812.100 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected. Specifically, *** 2
2983 21 CFR 812.140(a)(2)(iii) 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, *** 2
2991 21 CFR 812.140(b)(1) 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, *** 2
2993 21 CFR 812.140(b)(2) Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current]. Specifically, *** 2
3000 21 CFR 812.140(b)(4)(v) Sponsor records re QSR/GMP & non-significant risk studies For an investigation subject to the abbreviated requirements, records that include a statement of the extent to which the regulations covering current good manufacturing practice would be followed in manufacturing the device reports are not all [accurate] [complete] [current]. Specifically, *** 2
3021 21 CFR 812.150(a)(1) 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, *** 2
3065 21 CFR 812.140(a)(5) Additional investigator records FDA requires Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation] are not all [accurate] [complete] [current]. Specifically, *** 2
3138 21 CFR 820.130 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, *** 2
3139 21 CFR 820.140 Lack of or inadequate procedures for handling "Procedures for product handling have not been [adequately] established. Specifically,***" 2
3155 21 CFR 820.181(a) DMR device specifications The device master record does not include or refer to the location of device software specifications. Specifically, *** 2
3200 21 CFR 820.40(a) Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, *** 2
3264 21 CFR 820.250(b) Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established. Specifically,*** 2
3323 21 CFR 820.170(b) Installer records The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation. 2
3328 21 CFR 820.180(b) 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, *** 2
3346 21 CFR 820.200(b) Analyzing service report Service reports were not analyzed following appropriate statistical methods. Specifically, *** 2
3692 21 CFR 820.100(a)(4) 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, *** 2
4189 21 CFR 820.198(a) General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented]. Specifically, *** 2
14516 21 CFR 812.25(e) Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study. Specifically,*** 2
14521 21 CFR 812.36(e) 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, *** 2
14523 21 CFR 812.43(c) No investigator agreement A signed investigator agreement was not obtained from each participating investigator . Specifically,*** 2
636 21 CFR 803.17(b)(2) Reports and information documentation The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, *** 1
637 21 CFR 803.17(b)(3) Info used for semiannual reports, certification The written MDR procedure does not include documentation and recordkeeping requirements for any information that was evaluated for the purpose of preparing the submission of [semiannual reports] [certification]. Specifically, *** 1
648 21 CFR 803.18(e) MDR not evaluated per 820.162 and 820.198 A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding [Failure Investigations] [Complaint Files]. Specifically, *** 1
650 21 CFR 803.18(e) 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, *** 1
652 21 CFR 803.20(a)(1) Front of FDA form 3500A not completed The front side of FDA Form 3500A was not completed. Specifically, *** 1
654 21 CFR 803.20(a)(2) Sections G and H not completed by mfr. The device manufacturer did not complete Sections G and H on the back side of FDA Form 3500A. Specifically, *** 1
712 21 CFR 803.33(a) Failure to Submit Annual Reports Annual user facility reports have not been submitted to FDA. Specifically, *** 1
740 21 CFR 803.52(a)(3) Patient Gender An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's gender. Specifically, *** 1
745 21 CFR 803.52(b)(2) 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, *** 1
750 21 CFR 803.52(b)(4) Date of Report by the Initial Reporter An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of report by the initial reporter. Specifically, *** 1
757 21 CFR 803.52(c)(3) Manufacturer Name and Address An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block D the device manufacturer's name and address. Specifically, *** 1
763 21 CFR 803.52(c)(9) Device Available for Evaluation An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block D [whether the device was available for evaluation] [whether the device was returned to the manufacturer] [the date the device was returned to the manufacturer]. Specifically, *** 1
771 21 CFR 803.52(e)(1) Contact Office Name and Address An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the [contact office name and address] [device manufacturing site]. Specifically, *** 1
2481 21 CFR 820.30(c) Design input procedures - addressing conflicting requirement Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, *** 1
2602 21 CFR 820.30(d) Design output - review and approval Design output was not [reviewed] [approved] before release. Specifically, *** 1
2628 21 CFR 820.30(e) 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, *** 1
2910 21 CFR 812.7(a) Promotion or test marketing An investigational device was [promoted] [test marketed] prior to FDA approval/clearance. Specifically, *** 1
2937 21 CFR 812.43(c)(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, *** 1
2938 21 CFR 812.43(c)(2) No info on relevant experience in investigator agreement A signed agreement that includes the specifics of the investigator's relevant experience was not obtained from each participating investigator. Specifically, *** 1
2940 21 CFR 812.43(c)(4)(i) 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, *** 1
2941 21 CFR 812.43(c)(4)(ii) No supervision commitment in investigator agreement A signed agreement that includes a statement of the investigator's commitment to supervise all testing of the device involving human subjects was not obtained from each participating investigator. Specifically, *** 1
2944 21 CFR 812.43(d) Monitors not qualified Monitors that are qualified by [training] [experience] were not chosen to monitor the investigational study. Specifically, *** 1
2952 21 CFR 812.46(b)(1) No evaluation of unanticipated adverse effects An evaluation of reported unanticipated adverse device effects was not conducted. Specifically,*** 1
2972 21 CFR 812.110(a) 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, *** 1
2973 21 CFR 812.110(a) 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, *** 1
2975 21 CFR 812.110(c) Investigator did not supervise use of investigational device An investigational device was used for subjects not under the supervision of an authorized investigator. Specifically, *** 1
2992 21 CFR 812.140(b)(2) Sponsor device shipment records inadequate Records of shipment of an investigational device that include the [name and address of the consignee] [type and quantity of device] [date of shipment] [batch number or code mark] reports are not all [accurate] [complete] [current]. Specifically, *** 1
2994 21 CFR 812.140(b)(3) Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, *** 1
2995 21 CFR 812.140(b)(4) Availability of records of non-significant risk studies For an investigation subject to the abbreviated requirements, records are not [consolidated in one location] [available for FDA inspection and copying]. Specifically, *** 1
2996 21 CFR 812.140(b)(4)(i) Sponsor records re device use in non-significant risk study For an investigation subject to the abbreviated requirements, records which include the [name and intended use of the device] [objectives of the investigation] are not all [accurate] [complete] [current]. Specifically, *** 1
3003 21 CFR 812.140(b)(6) 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, *** 1
3025 21 CFR 812.150(a)(3) 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, *** 1
3028 21 CFR 812.150(a)(4) No approval for investigator change in non-emergency Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation. Specifically, *** 1
3043 21 CFR 812.150(b)(2) 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, *** 1
3049 21 CFR 812.150(b)(5) 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, *** 1
3111 21 CFR 820.70(f) 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, *** 1
3113 21 CFR 820.70(g) Equipment design and installation Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, *** 1
3115 21 CFR 820.70(h) Use and removal, Lack of or inadequate procedures Procedures for the use and removal of manufacturing material have not been [adequately] established. Specifically, *** 1
3164 21 CFR 820.184(d) 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, *** 1
3198 21 CFR 820.40(b) 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, *** 1
3230 21 CFR 820.70(i) 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, *** 1
3268 21 CFR 820.80(b) Incoming inspection, testing, verification Incoming product was not adequately inspected or tested to verify conformance to specifications. Specifically, *** 1
3291 21 CFR 820.100(b) Procedures The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented]. Specifically, *** 1
3332 21 CFR 820.184(e) ID label, labeling The device history record does not include the primary identification label and labeling for each device. Specifically, *** 1
3343 21 CFR 820.198(e) Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, *** 1
3355 21 CFR 820.198(f) Records accessibility Investigated complaints and records of investigation were not accessible to the manufacturing establishment. Specifically, *** 1
3371 21 CFR 820.198(a)(3) 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, *** 1
3377 21 CFR 820.198(e)(3) Device identification and control number Records of complaint investigations do not include device identifications and control numbers used. Specifically, *** 1
3383 21 CFR 820.198(g) Foreign complaint files The manufacturer's formally designated complaint unit is located outside of the United States and complaint records are not reasonably accessible in the United States. Specifically, *** 1
3672 21 CFR 820.30(c) Design input - review and approval Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, *** 1
3681 21 CFR 820.70(b) Verification or validation of changes Changes to a [specification] [method] [process] [procedure] were not verified or validated. Specifically, *** 1
3691 21 CFR 820.100(a)(4) Verification vs validation There is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation. Specifically, *** 1
4071 21 CFR 820.30(i) 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, *** 1
4192 21 CFR 806.10(a)(2) Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA. Specifically, *** 1
4201 21 CFR 806.10(c)(8) Illness report Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not been reported. Specifically,*** 1
4202 21 CFR 806.10(c)(9) Device number, identification The [total number] [sub-lot identification] of devices subject to correction or removal actions was not reported. Specifically,*** 1
4209 21 CFR 806.20(b)(1) Device name, identification The records of devices subject to correction and removal actions did not contain the device's [brand name] [common name] [usual name] [classification] [name] [product code] [intended use]. Specifically,*** 1
4211 21 CFR 806.20(b)(3) Events A description of the events that led to the correction or removal actions was not contained in the record. Specifically,*** 1
4213 21 CFR 806.20(b)(5) Records of communications A copy of all communications regarding the correction or removal action was not contained in the record. Specifically,*** 1
4252 21 CFR 821.25(c)(3) Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling [has not been established] [is not complete] [has not been followed]. Specifically,*** 1
6803 21 CFR 807.20(a) Devices not listed Devices for which listing is required have not been listed. Specifically, *** 1
7019 21 CFR 812.150(b)(10) No sponsor report in response to a request In response to a request from [FDA] [a reviewing IRB], [accurate] [complete] [current] information about an investigation was not provided. Specifically, *** 1
14512 21 CFR 812.2(c) Needs IDE; not a legally marketed device A clinical investigation requires but lacks an IDE, in that the device is not a legally marketed device being used according to labeling. Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
1105 21 CFR 211.22(d) Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, *** 145
3603 21 CFR 211.160(b) 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, *** 109
2027 21 CFR 211.192 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, *** 94
1361 21 CFR 211.100(a) 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, *** 87
1215 21 CFR 211.67(b) 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, *** " 72
1451 21 CFR 211.113(b) Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, *** 72
1883 21 CFR 211.165(a) 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, *** 64
1213 21 CFR 211.67(a) 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, *** 63
1274 21 CFR 211.68(a) 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, *** 54
1914 21 CFR 211.166(a) Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products. Specifically, *** 51
3585 21 CFR 211.110(a) 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, *** " 51
2419 21 CFR 211.198(a) 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, *** 47
1112 21 CFR 211.25(a) 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, *** 46
1358 21 CFR 211.100(b) 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, *** 43
2009 21 CFR 211.188 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, *** 43
1434 21 CFR 211.42(c)(10)(iv) Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, *** 42
1177 21 CFR 211.63 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, *** 41
4402 21 CFR 211.192 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, *** 38
1452 21 CFR 211.113(b) 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, *** 37
1809 21 CFR 211.160(a) Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, *** 36
1435 21 CFR 211.42(c)(10)(v) Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, *** 35
1111 21 CFR 211.25(a) 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, *** 33
2028 21 CFR 211.192 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, *** 32
4391 21 CFR 211.180(e)(2) 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, *** 30
1890 21 CFR 211.165(e) Test methods The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, *** 27
4314 21 CFR 211.84(d)(2) 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, *** 27
1159 21 CFR 211.28(a) 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, *** 26
1162 21 CFR 211.28(a) Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, *** 24
1932 21 CFR 211.167(a) 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, *** 24
2031 21 CFR 211.194(a) 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, , *** 24
4576 21 CFR 211.192 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, *** 24
9001 21 CFR 211.22(a) Lack of quality control unit There is no quality control unit. Specifically, *** 24
1263 21 CFR 211.68(b) 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, *** 23
4303 21 CFR 211.67 b) 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, *** 23
3602 21 CFR 211.160(a) Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, *** 22
1943 21 CFR 211.180(e)(1) 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, *** 21
2026 21 CFR 211.192 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, *** 21
1450 21 CFR 211.113(a) 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, *** 19
3572 21 CFR 211.100(b) Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, *** 19
4340 21 CFR 211.142 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, *** 19
1133 21 CFR 211.25(a) 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, *** 18
1227 21 CFR 211.67(c) Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, *** 18
1540 21 CFR 211.125(a) Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, *** 18
1891 21 CFR 211.165(f) Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, *** 18
3565 21 CFR 211.58 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, *** 18
4389 21 CFR 211.198(a) 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, *** 18
1885 21 CFR 211.165(b) Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, *** 17
3583 21 CFR 211.110(a) 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, *** 17
3632 21 CFR 211.170(b) 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, *** 17
6732 21 CFR 314.80(c)(1)(i) 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, *** 17
1787 21 CFR 211.80(a) 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, *** 16
1912 21 CFR 211.166(a) Written program not followed The written stability testing program is not followed. Specifically, *** 16
1098 21 CFR 211.22(c) 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, *** 15
1194 21 CFR 211.42(c) Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, *** 15
1926 21 CFR 211.166(b) 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, *** 15
6730 21 CFR 314.80(b) 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, *** 15
1433 21 CFR 211.42(c)(10)(iii) Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, *** 14
1801 21 CFR 211.84(a) 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, *** 14
1833 21 CFR 211.84(d)(1) 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, *** 14
1920 21 CFR 211.166a)(3) Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, *** 14
3547 21 CFR 211.46(b) 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, *** 14
3559 21 CFR 211.56(a) 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, *** 14
3571 21 CFR 211.100(a) 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, *** 14
4336 21 CFR 211.150 Written distribution procedure Written distribution procedures are not [established] [followed]. Specifically, *** 14
1975 21 CFR 211.182 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, *** 13
2008 21 CFR 211.186(a) Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, *** 13
4352 21 CFR 211.160(b)(4) 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, *** 13
4413 21 CFR 211.194(a)(8) 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, *** 13
1767 21 CFR 211.137(a) 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, *** 12
1810 21 CFR 211.160(a) 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, *** 12
4372 21 CFR 211.188(b)(8) 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, *** 12
1033 21 CFR 211.22(a) 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, *** 11
1169 21 CFR 211.42(a) 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, *** 11
1395 21 CFR 211.103 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, *** 11
1802 21 CFR 211.84(b) Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, *** 11
1942 21 CFR 211.180(e) 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, *** 11
4306 21 CFR 211.80(a) 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, *** 11
1261 21 CFR 211.68(a) 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, *** 10
1448 21 CFR 211.111 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, *** 10
2619 21 CFR 211.198(b)(2) Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, *** 10
4342 21 CFR 211.142(b) 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, *** 10
1079 21 CFR 211.22(a) 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, *** 9
1626 21 CFR 211.130 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, *** 9
1790 21 CFR 211.80(b) 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, *** 9
3613 21 CFR 211.160(b)(4) 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, *** 9
3639 21 CFR 211.204 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, *** 9
4401 21 CFR 211.186(b)(9) 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, *** 9
8907 21 CFR 314.81(b)(1)(ii) 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, *** 9
2033 21 CFR 211.194(c) 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, *** 8
3561 21 CFR 211.56(b) 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, *** 8
3616 21 CFR 211.165(d) 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, *** 8
4351 21 CFR 211.160(b)(3) Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, *** 8
8911 21 CFR 314.81(b)(1)(ii) 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, *** 8
1049 21 CFR 211.22(a) 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, *** 7
1086 21 CFR 211.22(b) 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, *** 7
1134 21 CFR 211.25(b) 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, *** 7
1136 21 CFR 211.25(c) Inadequate number of personnel The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, *** 7
1550 21 CFR 211.125(f) Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, *** 7
1844 21 CFR 211.84(d)(2) 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, *** 7
1933 21 CFR 211.167(a) Sterility/pyrogens - test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ****** 7
2205 21 CFR 211.186(b)(9) 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, *** 7
3592 21 CFR 211.110(c) 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, *** 7
17764 21 CFR 212.20(e) Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,*** 7
1270 21 CFR 211.68(b) input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, *** 6
1421 21 CFR 211.42(c)(10) 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,*** 6
1436 21 CFR 211.42(c)(10)(vi) Equipment to control conditions "Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, *** " 6
1869 21 CFR 211.94(c) 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, *** 6
3629 21 CFR 211.170(b) 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, *** 6
4325 21 CFR 211.110(a) 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,*** 6
4338 21 CFR 211.150(b) 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, *** 6
4350 21 CFR 211.160(b)(3) 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, *** 6
4357 21 CFR 211.166(a) Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, *** 6
1174 21 CFR 211.42(b) 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, *** 5
1454 21 CFR 211.115(a) 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, *** 5
1495 21 CFR 211.122(a) 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, *** 5
1496 21 CFR 211.122(a) 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, *** 5
1725 21 CFR 211.134(c) Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, *** 5
1886 21 CFR 211.165(c) 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, *** 5
2007 21 CFR 211.186(a) 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, *** 5
2044 21 CFR 211.196 Distribution Record Requirements Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, *** 5
3545 21 CFR 211.44 Adequate lighting not provided Adequate lighting is not provided in all areas. Specifically, *** 5
4406 21 CFR 211.194(a)(2) Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use. Specifically, *** 5
4409 21 CFR 211.194(a)(4) 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, *** 5
17812 21 CFR 212.50 Adequate controls (general) Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. Specifically,*** 5
17851 21 CFR 212.60(c) Analytical methods Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible]. Specifically,*** 5
1256 21 CFR 211.68(b) Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system. Specifically, *** 4
1388 21 CFR 211.101(d) Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person. Specifically, *** 4
1798 21 CFR 211.82(b) 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, *** 4
1803 21 CFR 211.84(b) Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, *** 4
1851 21 CFR 211.84(e) 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, *** 4
1918 21 CFR 211.166(a)(2) Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, *** 4
2012 21 CFR 211.188(b) 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, *** 4
2034 21 CFR 211.194(d) Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, *** 4
2567 21 CFR 211.198(a) 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, *** 4
3557 21 CFR 211.52 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, *** 4
3570 21 CFR 211.100(a) 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, *** 4
3582 21 CFR 211.105(a) 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, *** 4
3591 21 CFR 211.110(b) 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, *** 4
3614 21 CFR 211.160(b)(4) 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, *** 4
4343 21 CFR 211.160(b)(1) 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, *** 4
4382 21 CFR 211.198(b)(2) 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, *** 4
4400 21 CFR 211.186(b)(8) 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, *** 4
4403 21 CFR 211.194(b) 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, *** 4
4410 21 CFR 211.194(a)(5) Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, *** 4
4418 21 CFR 211.42(b) Adequate space lacking to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination. Specifically, *** 4
17763 21 CFR 212.20(d) Determination need for investigation When errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,*** 4
1163 21 CFR 211.28(b) Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits. Specifically, *** 3
1220 21 CFR 211.67(b)(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, *** " 3
1266 21 CFR 211.42(d) 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, *** 3
1393 21 CFR 211.103 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person. Specifically, *** 3
1632 21 CFR 211.130(c) 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, *** 3
1633 21 CFR 211.130(d) 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, *** 3
1726 21 CFR 211.86 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, *** 3
1728 21 CFR 211.87 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, *** 3
1774 21 CFR 211.142(a) Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit. Specifically, *** 3
1876 21 CFR 211.180(a), (b) 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, *** 3
1917 21 CFR 211.166(a)(1) 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, *** 3
1927 21 CFR 211.166(b) 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, *** 3
1958 21 CFR 211.180(f) 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, *** 3
1976 21 CFR 211.182 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, *** 3
2198 21 CFR 211.186(b)(3) Component Name and Code The master production and control records are deficient in that they do not include a complete list of components designated by [name] [code] sufficiently specific to indicate any special characteristic. Specifically, *** 3
2399 21 CFR 211.194(a)(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, *** 3
2402 21 CFR 211.194(a)(5) Testing Calculations Laboratory records are deficient in that they do not include all calculations performed during testing. Specifically, *** 3
2406 21 CFR 211.194(a)(8) 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, *** 3
2420 21 CFR 211.198(a) 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, *** 3
3562 21 CFR 211.56(c) 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, *** 3
3630 21 CFR 211.170(b) 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, *** 3
4307 21 CFR 211.80(d) 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, *** 3
4320 21 CFR 211.84(d)(6) 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, *** 3
4324 21 CFR 211.110(b) In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, *** 3
4353 21 CFR 211.160(b)(4) Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, *** 3
4399 21 CFR 211.186(b)(7) 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, *** 3
4404 21 CFR 211.194(a)(1) 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, *** 3
4412 21 CFR 211.194(a)(7) 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, *** 3
6728 21 CFR 314.80(b) 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, *** 3
6823 21 CFR 314.80(c) Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA. Specifically, *** 3
17749 21 CFR 212.30(a) Prevention of contamination Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by [substances] [personnel] [environmental conditions] that could reasonably be expected to have an adverse effect on product quality. Specifically,*** 3
17769 21 CFR 212.40(a) Content of written procedures You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures]. Specifically,*** 3
17813 21 CFR 212.50(a) Written control procedures You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified]. Specifically,*** 3
17932 21 CFR 212.60(b) Testing Procedures- Conformance to Standards Each laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,*** 3
17939 21 CFR 212.71(a) Procedures to Investigate Cause of Non-Conforming Product You did not [establish] [follow] procedures to investigate the cause(s) of the nonconforming batch(s) of a PET drug product. Specifically, *** 3
1168 21 CFR 211.34 Consultant Records Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, *** 2
1223 21 CFR 211.67(b)(5) 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, *** 2
1384 21 CFR 211.101(c) Weighing/measuring/subdividing operations Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, *** 2
1411 21 CFR 211.105(b) 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, *** 2
1449 21 CFR 211.111 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, *** 2
1505 21 CFR 211.122(d) Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, *** 2
1545 21 CFR 211.125(c) 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, *** 2
1630 21 CFR 211.130(b) 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, *** 2
1637 21 CFR 211.130(e) 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, *** 2
1777 21 CFR 211.150(b) 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, *** 2
1797 21 CFR 211.82(a) 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, *** 2
1845 21 CFR 211.84(d)(3) Container/Closure Written Test Procedure Drug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance with appropriate written procedures. Specifically, *** 2
1852 21 CFR 211.94(a) 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, *** 2
1868 21 CFR 211.94(b) Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. Specifically, *** 2
1879 21 CFR 211.180(c) 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, *** 2
2014 21 CFR 211.188(b)(2) 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, *** 2
2203 21 CFR 211.186(b)(7) 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, *** 2
2621 21 CFR 211.198(b)(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, *** 2
3445 21 CFR 211.65(a) 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, *** 2
3546 21 CFR 211.46(a) Adequate ventilation not provided Adequate ventilation is not provided. Specifically, *** 2
3548 21 CFR 211.46(c) Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system. Specifically, *** 2
3550 21 CFR 211.46(c) 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, *** 2
3553 21 CFR 211.48(a) Plumbing System Defects The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, *** 2
3569 21 CFR 211.89 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, *** 2
3573 21 CFR 211.101(b) Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, *** 2
3596 21 CFR 211.122(g) Failure to include one of special control procedures Packaging and labeling operations involving the use of cut labels fail to include one of the three special control procedures provided for in the regulations ( e.g., dedicated lines, automated equipment for 100% exam, visual inspection for 100% exam). Specifically, *** 2
3610 21 CFR 211.160(b)(3) Drug product sample Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, *** 2
4302 21 CFR 211.56(b) Written sanitation procedures not followed Written procedures for sanitation are not followed. Specifically, *** 2
4315 21 CFR 211.84(d)(2) 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, *** 2
4344 21 CFR 211.160(b)(1) Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, *** 2
4345 21 CFR 211.160(b)(1) Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified]. Specifically, *** 2
4354 21 CFR 211.165(d) Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, *** 2
4355 21 CFR 211.165(c) Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product. Specifically, *** 2
4359 21 CFR 211.170(a)(1), (b)(1) 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. 2
4373 21 CFR 211.188(b)(7) 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, *** 2
4375 21 CFR 211.188(b)(5) 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, *** 2
4378 21 CFR 211.188(b)(2) 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, *** 2
4380 21 CFR 211.198(b)(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, *** 2
4388 21 CFR 211.198(a) 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, *** 2
6736 21 CFR 314.80(c)(1)(ii) 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, *** 2
6830 21 CFR 314.80(c)(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, *** 2
6832 21 CFR 314.80(c)(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, *** 2
6842 21 CFR 314.80(i) Failure to maintain records Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period. Specifically, *** 2
8906 21 CFR 314.81(b)(1)(i) 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, *** 2
8912 21 CFR 314.81(b)(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, *** 2
17743 21 CFR 212.30(b) Equipment procedures overall You did not implement procedures to ensure that all your equipment is [properly installed] [maintained] [capable of repeatedly producing valid results]. Specifically,*** 2
17853 21 CFR 212.60(d) Supplies adequately controlled Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled. Specifically,*** 2
17858 21 CFR 212.60(f) Documenting procedures You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment. Specifically,*** 2
17859 21 CFR 212.60(g) Test records complete (general) Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,*** 2
17863 21 CFR 212.60(g)(3) Record of all test data Laboratory records did not contain a complete record of all data obtained in the course of each test. Specifically,*** 2
17864 21 CFR 212.60(g)(4) Statement of results and comparisons Laboratory test records did not contain a statement [of the results of tests] [how the results compare with established acceptance criteria]. Specifically,*** 2
17867 21 CFR 212.61(a) Stability testing program You did not [establish] [follow] [maintain] a written testing program to assess the stability characteristics of your PET drug products. Specifically,*** 2
17913 21 CFR 212.100(a) Written complaint procedures You have not [developed] [followed] written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,*** 2
1219 21 CFR 211.67(b)(2) Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, *** 1
1222 21 CFR 211.67(b)(4) 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, *** 1
1224 21 CFR 211.67(b)(6) Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, *** 1
1396 21 CFR 211.42(c)(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,*** 1
1430 21 CFR 211.42(c)(10)(i) 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,*** 1
1498 21 CFR 211.122(b) Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, *** 1
1504 21 CFR 211.122(d) Labels and labeling stored separately Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. Specifically, *** 1
1506 21 CFR 211.122(e) Destruction of obsolete labeling Obsolete or outdated labels, labeling and packaging materials are not destroyed. Specifically, *** 1
1541 21 CFR 211.125(b) 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, *** 1
1549 21 CFR 211.125(e) Return of labeling Returned labeling is not maintained and stored in a manner to [prevent mix-ups] [provide proper identification]. Specifically, *** 1
1722 21 CFR 211.134(a) 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, *** 1
1768 21 CFR 211.137(b) Storage conditions Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, *** 1
1791 21 CFR 211.80(c) 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, *** 1
1794 21 CFR 211.80(d) 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, *** 1
1843 21 CFR 211.84(d)(2) Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, *** 1
1870 21 CFR 211.94(d) Written Procedures to Remove Pyrogens "There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties. Specifically, *** " 1
1922 21 CFR 211.166(a)(4) 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, *** 1
1924 21 CFR 211.166(a)(5) Testing of reconstituted drugs The written stability program does not include testing of drug products for reconstitution [at time of dispensing - as directed in the labeling] [after they are reconstituted]. Specifically, *** 1
1939 21 CFR 211.167(c) Controlled release test methods written, followed Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed]. Specifically, *** 1
1957 21 CFR 211.180(e)(2) 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, *** 1
1978 21 CFR 211.182 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, *** 1
2001 21 CFR 211.184(b) 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, *** 1
2003 21 CFR 211.184(c) 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, *** 1
2004 21 CFR 211.184(d) 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, *** 1
2016 21 CFR 211.188(b)(4) 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, *** 1
2020 21 CFR 211.188(b)(8) 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, *** 1
2023 21 CFR 211.188(b)(11) 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, *** 1
2087 21 CFR 211.208 Salvaging performed without evidence Salvaging operations on drug products which may have been subjected to improper storage conditions proceeded in the absence of evidence from [laboratory tests and assays to establish that the drug products meet all applicable standards of identity, strength, quality and purity] [inspection of the premises to establish that the drug products and their associated packaging were not subjected to improper storage conditions as a result of a disaster or accident]. Specifically, *** 1
2197 21 CFR 211.186(b)(2) Active Ingredient Name and Weight The master production and control records are deficient in that they do not include the [name] [weight] of each active ingredient per dosage unit or unit of weight statement of total weight or measure of any dosage unit. Specifically, *** 1
2201 21 CFR 211.186(b)(5) Calculated Excess of Components Used The master production and control records are deficient in that they do not include a statement concerning any calculated excess of component. Specifically, *** 1
2401 21 CFR 211.194(a)(4) Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, *** 1
2618 21 CFR 211.198(b)(1) Complaint Record required information Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, *** 1
17962 21 CFR 361.1(c)(2) Numerical votes not in the minutes of any RDRC meetings The minutes of an RDRC meeting did not include the numerical results of votes on protocols involving use in human subjects. Specifically, *** 1
17968 21 CFR 361.1(c)(3) FDA research proposals not reported +30 subjects The RDRC did not [immediately] report to FDA a research proposal that involves exposure of more than thirty (30) subjects. Specifically, *** 1
3554 21 CFR 211.48(a) 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, *** 1
3555 21 CFR 211.48(b) 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, *** 1
3564 21 CFR 211.56(d) Sanitation work procedures not followed by contractors Sanitation work performed by [contractors] [temporary employees] does not follow the same sanitation procedures performed by full-time employees. Specifically, *** 1
3567 21 CFR 211.84(d)(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, *** 1
3581 21 CFR 211.101(d) Verification of component addition Each component is not added to the batch by one person and verified by a second person.. Specifically, *** 1
3588 21 CFR 211.110(a)(3) 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, *** 1
3604 21 CFR 211.160(b)(1) Determination of conformance Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not made for each lot within each shipment of [components] [drug product containers] [closures] [labeling] used in the manufacture, processing, packing or holding of drug products. Specifically, *** 1
3611 21 CFR 211.160(b)(3) Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, *** 1
3623 21 CFR 211.170(a) 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, *** 1
3631 21 CFR 211.170(b) Investigation of reserve sample deterioration "Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained with other stability data]. Specifically, *** " 1
3636 21 CFR 211.170(b)(3) Retention time for some OTC drugs OTC drug product reserve samples exempt from bearing an expiration date are not retained for three years after the lot or batch of drug product is distributed. Specifically, *** 1
3640 21 CFR 211.204 Returned drug products identified and held Returned drug products are not [identified as such] [held]. Specifically, *** 1
4304 21 CFR 211.68(b) 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, *** 1
4305 21 CFR 211.68(b) 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, *** 1
4316 21 CFR 211.84(d)(3) Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, *** 1
4323 21 CFR 211.115(a) 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, *** 1
4327 21 CFR 211.122(c) 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, *** 1
4328 21 CFR 211.122(a) Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, *** 1
4337 21 CFR 211.150(a) Distribution of oldest stock first Distribution procedures do not include a procedure whereby the oldest approved stock of a drug product is distributed first. Specifically, *** 1
4347 21 CFR 211.160(b)(2) In process materials - conformance to written specs Laboratory controls do not include a determination of conformance to written specifications for in-process materials. Specifically, *** 1
4356 21 CFR 211.166(b) 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, *** 1
4364 21 CFR 211.176 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, *** 1
4368 21 CFR 211.188(b)(12) 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, *** 1
4369 21 CFR 211.188(b)(11) 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, *** 1
4371 21 CFR 211.188(b)(9) Description of containers and closures Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced. Specifically, *** 1
4377 21 CFR 211.188(b(3) 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, *** 1
4383 21 CFR 211.198(b)(1) 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, *** 1
4386 21 CFR 211.198(b) 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, *** 1
4390 21 CFR 211.180c) Photocopying of records not allowed Records or copies of records were not made available for photocopying or other means of reproduction. Specifically, *** 1
6706 21 CFR 310.305(c)(1)(i) Late submission Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information. Specifically, *** 1
6729 21 CFR 314.80(b) Failure to submit follow-up information to FDA Follow-up information has not been submitted on adverse drug experience reports provided to you by FDA. Specifically, *** 1
6735 21 CFR 314.80(c)(1)(ii) Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, *** 1
6833 21 CFR 314.80(c)(2)(ii) 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, *** 1
6839 21 CFR 314.80(e)(2) Failure to identify post marketing study reports Not all reports of adverse drug experiences that occurred during post marketing studies were [separated] [clearly marked] as being distinct from those experiences reported spontaneously to you. Specifically, *** 1
8908 21 CFR 314.81(b)(2)(i) 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, *** 1
8919 21 CFR 314.81(b)(2)(vii) Post marketing study status not included An annual report did not include the status of each post marketing study concerning [clinical safety] [clinical efficacy] [clinical pharmacology] [non-clinical toxicology] required by FDA or to which the applicant has committed in writing to conduct. Specifically, *** 1
8921 21 CFR 314.81(b)(2)(vii)(a) Post marketing study status report required information An annual, status report of a post marketing study did not include [the applicant's name] [the product name] [the NDA, ANDA, and supplement number] [the date of U.S. approval of NDA or ANDA] [the date of post marketing study commitment] [a description of the post marketing study commitment sufficient to uniquely describe the study] [a schedule for completion and reporting of the post marketing study commitment] [the current status of the post marketing study commitment] [an explanation of the study's status]. Specifically, *** 1
8935 FDCA 760(b)(1) Failure of responsible person to report AE (non-RX Drug) Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, *** 1
8936 FDCA 760(b)(1) No label copy submitted with AE report (non-Rx drug) Copies of labels from on or within the retail package of a non-prescription drug did not accompany serious drug event report. Specifically, *** 1
10019 21 CFR 314.80(c)(1)(iii) Non-applicant reports directly to FDA You, as a non-applicant, did not elect to submit to the applicant all reports of adverse drug experiences that were both serious and unexpected. You were therefore obligated to submit those reports directly to FDA, but you did not submit each report [within five calendar days of your receipt of the information]. Specifically, *** 1
10022 21 CFR 310.305(a) 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, *** 1
17002 FDCA 501(a) Drug Field Exam During a field examination of drug products at your facility the following [was] [were] observed: 1
17741 21 CFR 212.30(b) Equipment not clean You did not implement procedures to ensure that all your equipment is clean. Specifically, *** 1
17755 21 CFR 212.20(a) Oversight of production operations You did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is supposed to have]. Specifically, *** 1
17757 21 CFR 212.20(b) Examine, approve or reject You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug. Specifically,*** 1
17760 21 CFR 212.20(c) Initial specifications, methods, processes You did not approve or reject, before implementation, initial [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug. Specifically,*** 1
17761 21 CFR 212.20(c) Proposed changes to existing specs/methods You did not approve or reject, before implementation, proposed changes to existing [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug. Specifically,*** 1
17770 21 CFR 212.40(a) Suitable for intended use Your written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use. Specifically,*** 1
17784 21 CFR 212.40(c)(2) Rep.sample - containers/closures You did not examine a representative sample of each lot of [containers] [closures] for conformity to written specifications. Specifically,*** 1
17787 21 CFR 212.40(d) Contamination, mix-ups and deterioration You did not handle and store [components] [containers] [closures] in a manner that prevents [contamination] [mix-ups] [deterioration] and ensures that they are and remain suitable for their intended use. Specifically,*** 1
17823 21 CFR 212.50(b)(8) Container & label descriptions Your master production and control records did not contain [a description of the PET drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling]. Specifically,*** 1
17835 21 CFR 212.50(c)(7) ID of major equipment Your batch production and control records did not include the identification of major pieces of equipment used in production of the batch. Specifically,*** 1
17838 21 CFR 212.50(c)(10) Initials or signatures Your batch production and control records did not include the initials or signatures of persons performing or checking each significant step in the operation. Specifically,*** 1
17841 21 CFR 212.50(d) Production area & equipment checks Your [production area] [equipment in the production area] was not checked to ensure [cleanliness] [suitability] immediately before use. Specifically,*** 1
17846 21 CFR 212.50(f)(2) Documentation of activities You did not document your process verification [activities] [results]. Specifically,*** 1
17847 21 CFR 212.50(f)(2) Documentation must include The documentation of your process verification activities and results does not include [the date and signature of the individual(s) performing the verification] [the monitoring and control methods and data] [the major equipment qualified]. Specifically,*** 1
17850 21 CFR 212.60(b) Lab sampling and test procedures Each laboratory did not have sampling procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,*** 1
17857 21 CFR 212.60(f) Lab written procedures Laboratory written procedures are not [established] [followed] to ensure that the lab equipment is routinely [calibrated] [inspected] [checked] [maintained]. Specifically,*** 1
17875 21 CFR 212.70(b) Compendial test procedure You did not first [verify] [document] that an established compendial test procedure works under the conditions of actual use. Specifically,*** 1
17877 21 CFR 212.70(c) Conform to specs prior to release You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release. Specifically,*** 1
17896 21 CFR 212.71(a) Rejection of nonconforming product You did not reject the batch of a PET drug product that did not conform to specifications. Specifically,*** 1
17904 21 CFR 212.80(d) Labeling and product mix-ups Labeling and packaging operations for PET drug products were not controlled to prevent labeling and product mix-ups. Specifically,*** 1
17906 21 CFR 212.90(a) Written distribution procedures You have not [established] [maintained] [followed] written procedures for the control of distribution of PET drug products to ensure that the method of shipping chosen will not adversely affect the identity, purity or quality of the PET drug product. Specifically, *** 1
17918 21 CFR 212.70(f)(1)(iv) Correct malfunction, re-do test You approved a conditional final release of a PET drug product batch due to analytical equipment malfunction, but you did not [promptly correct the malfunction of analytical equipment] [complete the omitted test using the reserve sample after correcting the malfunction] [document that reasonable efforts had been made to prevent recurrence of the malfunction]. Specifically,*** 1
17921 21 CFR 212,70(f)(2) Radiochemical test prevented You approved a conditional final release of a PET drug product batch due to analytical equipment malfunction, but the malfunction involving the analytical equipment [prevents the performance of a radiochemical identity/purity test] [prevents the determination of the product's specific activity]. Specifically,**** 1
17923 21 CFR 212.100(c) Complaint record contents Your written complaint record does not include [the name and strength of the PET drug product] [the batch number] [the name of the complainant] [the date the complaint was received] [the nature of the complaint] [the response to the complaint] [the findings of any investigation and follow-up]. Specifically,*** 1
17931 21 CFR 212.60(a) Testing Procedures - Documentation of Results Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug products] does not [have written procedures] [follow written procedures] for the documentation of the results. Specifically,*** 1
17934 21 CFR 212.60(g)(3) Laboratory Records Lack Required Data Laboratory records did not contain [all graphs, charts, and spectra from the laboratory instrumentation] [properly identified graphs, charts, and spectra from laboratory instrumentation] to show the specific [component] [in-process material] [drug product] for each lot tested. Specifically.*** 1
17935 21 CFR 212.70(b) Before implementing new procedure document accuracy etc. You implemented a new test procedure in a specification, but you did not first document the [accuracy] [sensitivity] [specificity] [reproducibility] of the procedure. Specifically,*** 1
17947 21 CFR 361.1(c)(1)(ii) RDRC not incl trained person to formulate radioactive drugs The RDRC membership does not include a person trained to formulate radioactive drugs. Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
4185 FDCA 402(a)(4) Record keeping Treatment records were not [maintained] [complete]. Specifically,*** 196
4093 21 CFR 530.11(d) 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, *** 151
7001 FDCA 402(a)(4) Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, *** 53
13509 FDCA 402(a)(4) 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, *** 43
1360 FDCA 501(a)(5) Expired drugs Expired drug(s) were observed in the drug storage area. Specifically, *** 32
4298 21 CFR 530.11(a) 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, *** 32
13521 21 CFR 530.41(a) 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, *** " 29
4186 FDCA 402(a)(4) System for administration of drugs Failure to have a system to control administration of drug treatments to your animals. Specifically, *** 25
1442 FDCA 402(a)(4) 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, *** 24
4097 21 CFR 530.20(a)(2)(iv) 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, *** 24
1389 21 CFR 530.11(a) 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, *** 18
4182 FDCA 501(a)(5) 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, *** 17
1362 21 CFR 530.11(a) 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, *** 16
1366 21 CFR 530.11(a) Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship. Specifically, *** 16
1446 FDCA 402(a)(4) Hospital pen Failure to [identify] [segregate] [quarantine] treated animals. Specifically, *** 16
4184 FDCA 501(a)(5) Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, *** 15
13508 FDCA 402(a)(4) 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, *** 14
1457 FDCA 402(a)(4) Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, *** 10
1373 21 CFR 530.11(a) 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, *** 8
4111 21 CFR 530.12(c) 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, *** 8
1376 21 CFR 530.11(a) 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, *** 7
4100 21 CFR 530.20(a)(2)(iii) 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, *** 7
1792 21 CFR 225.42(b)(7) Discrepancies Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage. Specifically, *** 6
1923 21 CFR 225.65(b) 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, *** 6
4564 21 CFR 225.180 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, *** 6
4098 21 CFR 530.20(a)(2)(i) 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, *** 6
4113 21 CFR 530.12(e) 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, *** 6
4545 21 CFR 225.120 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, *** 5
4094 21 CFR 530.11(b) 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, *** 5
4552 21 CFR 225.142 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, *** 4
4555 21 CFR 225.142 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, *** 4
4099 21 CFR 530.20(a)(2)(ii) 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, *** 4
4101 21 CFR 530.20(a)(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, *** 4
1466 21 CFR 225.20(b)(2) Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner. Specifically, *** 3
1482 21 CFR 225.30(b)(1) Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, *** 3
1760 21 CFR 225.42(b)(6) 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, *** 3
1811 21 CFR 225.58(b)(1) 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, *** 3
2359 21 CFR 226.58(e) Test method reliability "Laboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures. Specifically, ***" 3
1575 21 CFR 225.42(b)(4) Integrity and identity Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, *** 2
1782 21 CFR 225.42(b)(7) 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, *** 2
1821 21 CFR 225.58(b)(1) 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, *** 2
1882 21 CFR 225.58(e) 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, *** 2
2074 21 CFR 225.102(a) 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, *** 2
2076 21 CFR 225.102(b)(1) 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, ***" 2
2093 21 CFR 225.102(b)(2)(i)-(iv) 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, *** 2
2098 21 CFR 225.102(b)(4) Discrepancies investigated, reported "When significant discrepancies were noted on the batch production records, there was a failure to [institute an investigation immediately] [describe the corrective action taken on the production record]. Specifically, *** " 2
2353 21 CFR 226.58(b) Specifications, test procedures - Type A medicated articles Laboratory controls do not include [the establishment of adequate specifications] [a description of laboratory test procedures to check specifications] to assure that Type A medicated articles conform to appropriate specifications. Specifically, *** 2
4560 21 CFR 225.165 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, *** 2
4108 21 CFR 530.12(a) 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, *** 2
4116 21 CFR 530.13(b)(2) Approved drug available Compounding a drug from an approved human or animal drug, where there already exists an approved human or animal drug which would appropriately treat the condition diagnosed. Specifically, *** 2
4146 21 CFR 589.2000(e)(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, *** 2
4157 21 CFR 225.42(b)(7) Detention of feeds with yield discrepancies Medicated feeds implicated in drug inventory discrepancies based on a comparison of actual vs. theoretical usage are not detained until the discrepancies have been reconciled. Specifically, *** 2
4183 FDCA 501(a)(5) Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed]. Specifically, *** 2
4453 21 CFR 225.10(b)(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, *** 2
13541 FDCA 501(a)(5) 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, *** 2
1254 21 CFR 225.10(b)(1) Training "Employees involved in the manufacture of medicated feeds lack an understanding of the manufacturing or control operations which they perform. Specifically, ***" 1
1262 21 CFR 225.10(b)(2) 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, *** 1
1447 FDCA 402(a)(4) Feeding areas Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids. Specifically, *** 1
1469 21 CFR 225.20(b)(3) Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, *** 1
1491 21 CFR 225.30(b)(2) Maintenance reasonably clean & orderly Equipment is not maintained in a reasonably clean and orderly manner. Specifically, *** 1
1493 21 CFR 225.30(b)(4) 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, *** 1
1539 21 CFR 225.42(b)(3) 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, *** 1
1634 21 CFR 225.42(b)(5) Receipt for each lot of drug received Failure to [prepare] [maintain] a receipt record for each lot of drug received. Specifically, *** 1
1638 21 CFR 225.42(b)(5) 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, *** 1
1744 21 CFR 225.42(b)(6) Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, *** 1
1765 21 CFR 225.42(b)(6)(i) - (v) 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, *** 1
1826 21 CFR 225.58(b)(1) Alternate testing of drugs in combination Where only one drug is assayed in a medicated feed containing a combination of drugs, there was a failure to test a different drug from the one(s) previously tested during the calendar year. Specifically,*** 1
1850 21 CFR 225.58(d) 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,*** 1
1930 21 CFR 225.65(b)(3) Sequential production Sequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs. Specifically, *** 1
1952 21 CFR 225.80(b)(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, *** 1
2097 21 CFR 225.102(b)(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, ***" 1
2232 21 CFR 225.115(b)(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, *** 1
2379 21 CFR 226.40(e) Cleaning to prevent contamination of Type A articles Failure to use adequate procedures for cleaning of those parts of equipment which come into contact with drug components of Type A medicated articles, to avoid contamination of Type A medicated articles. Specifically, *** 1
2416 21 CFR 226.80(b)(2) Label examination "Packaging and labeling operations do not provide for careful checking of labeling for identity and conformity to the labeling specified in the batch production records. Specifically, ***" 1
2421 21 CFR 226.110 Records maintenance Complete records are not maintained for each shipment of Type A medicated article in a manner that will facilitate [recall] [diversion] [destruction] if necessary. Specifically, *** 1
4547 21 CFR 225.130 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, *** 1
4553 21 CFR 225.142 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, *** 1
4557 21 CFR 225.158 Investigation and corrective action Results of laboratory assays of drug components indicated that medicated feed was not in accord with the permissible limits, and no [investigation] [corrective action] was implemented immediately. Specifically, *** 1
4558 21 CFR 225.158 Records kept for one year Records of [investigation] [corrective action] with respect to assays of drug components not meeting permissible levels are not maintained on the premises for a period of one year. Specifically, *** 1
4562 21 CFR 225.180 Assuring correct labels are used Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the medicated feed]. Specifically, *** 1
4567 21 CFR 225.202 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, *** 1
4109 21 CFR 530.12(a) Name and address - drug dispensed by pharmacist Failure to provide labeling showing the [name of the prescribing veterinarian] [name and address of the dispensing pharmacist] for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, *** 1
4110 21 CFR 530.12(b) Names of active ingredients Failure to provide labeling showing the established name of each active ingredient for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, *** 1
4117 21 CFR 530.13(b)(2) From human drug where animal drug available Compounding a drug from an approved human drug, where an approved animal drug could be used for the compounding. Specifically, *** 1
4131 21 CFR 589.2000(c)(1)(i) 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, *** 1
4132 21 CFR 589.2000(d)(1) 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, *** 1
4145 21 CFR 589.2000(e)(1) Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, *** 1
4155 21 CFR 226.115 Appropriate action not taken Appropriate action is not taken as a result of evaluation of complaints on Type A medicated articles. Specifically, *** 1
4454 21 CFR 225.20(a) Facilities features The features of the facility necessary for the proper manufacture of medicated feeds fail to provide for [ease of access to structures and equipment for routine maintenance] [ease of cleaning of equipment and work areas] [facilities to promote personal hygiene] [structural conditions for control of vermin and pests] [adequate space for the orderly receipt and storage of drugs and feed ingredients] [adequate space for the controlled flow of materials through the processing and manufacturing operations] [equipment necessary for the accurate packaging and delivery of a medicated feed of specified labeling and composition]. Specifically, *** 1
13532 21 CFR 511.1(b)(7)(ii) 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, *** 1
13534 21 CFR 511.1(b)(7)(ii) Records: Maintenance Complete records of the investigation were not maintained. Specifically, *** 1
13565 21 CFR 589.2001(c)(2)(ii) Renderer's maintaining adequate written procedures Failure to maintain adequate written procedures specifying how the process of [removing the brain and spinal cord from cattle not inspected and passed for human consumption] [separating animals based on whether or not they are 30 months of age or older] is carried out. Specifically,*** 1
13567 21 CFR 589.2001(c)(2)(iv) 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,*** 1
13569 21 CFR 589.2001(c)(2)(vi) Tracking records: establish, maintain, make available Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed. Specifically,*** 1
13571 21 CFR 589.2001(c)(3)(i) Records:establish, maintain, make available Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, cattle materials prohibited in animal feed. Specifically,*** 1
13578 21 CFR 589.2001(c)(1) Comply with 589.2001 Failure to comply with all applicable requirements in the regulations regarding cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy (BSE). Specifically,*** 1
Cite Id Reference Number Short Description Long Description Frequency
7560 21 CFR 312.60 FD-1572, protocol compliance "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically*** " 164
7530 21 CFR 312.62(b) 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, ***" 99
7526 21 CFR 312.62(a) Accountability records "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***" 38
7562 21 CFR 312.60 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*** 23
7281 21 CFR 56.108(a)(1) Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, *** 19
7318 21 CFR 56.115(a)(2) 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, *** 19
7482 21 CFR 312.50 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, *** 19
7520 21 CFR 312.64(b) 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, *** 14
7227 21 CFR 50.27(a) 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, *** 13
7334 21 CFR 56.115(a)(5) 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, *** 9
7498 21 CFR 312.66 Unanticipated problems "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***" 9
7231 21 CFR 50.20 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, *** 8
7278 21 CFR 56.107(e) 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, *** 8
7321 21 CFR 56.110(c) 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, *** 8
7290 21 CFR 56.108(c) 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, *** 7
7293 21 CFR 56.109(f) 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, *** 7
7317 21 CFR 56.115(a)(1) 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, *** 7
7517 21 CFR 312.66 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, *** 7
7209 21 CFR 50.25(a)(1) 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, *** 6
7391 21 CFR 50.25(a)(5) 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, *** 5
7335 21 CFR 56.115(a)(6) 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, *** 5
7531 21 CFR 312.62(c) 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, ***" 5
7552 21 CFR 312.66 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, *** 5
7384 21 CFR 50.25(b)(1) Statement of risks The informed consent document did not contain a statement that the test article or procedure might involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. Specifically, *** 4
7342 21 CFR 56.108(b)(2) 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, *** 4
7368 21 CFR 56.108(a)(2) 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, *** 4
7370 21 CFR 56.111(c) 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, *** 4
7388 21 CFR 50.25(a)(2) Reasonably foreseeable risks or discomforts The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, *** 3
7392 21 CFR 50.25(a)(7) 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, *** 3
4007 21 CFR 58.130(a) Conduct: in accordance with protocol "Not all nonclinical laboratory studies were conducted in accordance with the protocol. Specifically, ***" 3
7277 21 CFR 56.107(d) 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, *** 3
7316 21 CFR 56.115(a)(4) Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, *** 3
7369 21 CFR 56.109(h) 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, *** 3
7371 21 CFR 56.108(a)(1) 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, *** 3
7411 21 CFR 312.53(c)(1) 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, *** 3
7656 21 CFR 56.108(c) 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, *** 3
7664 21 CFR 50.20 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, *** 3
7390 21 CFR 50.25(a)(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, *** 2
3914 21 CFR 58.31(f) Management: personnel understand their functions Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, *** 2
3965 21 CFR 58.90(a) Animal care: SOPs Standard operating procedures for the housing, feeding, handling, and care of animals did not exist. Specifically, *** 2
7274 21 CFR 56.107(a) 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, *** 2
7286 21 CFR 56.108(b)(1) 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, *** 2
7297 21 CFR 56.109(b) 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, ***: 2
7320 21 CFR 56.109(e) 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, *** 2
7324 21 CFR 56.111(a)(4) Informed consent sought The IRB approved the conduct of research, but did not determine that informed consent would be sought from each prospective subject or the subject's legally authorized representative, to the extent required by 21 CFR 50. Specifically, *** 2
7337 21 CFR 56.115(b) Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, *** 2
7339 21 CFR 56.108(a)(4) 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, *** 2
7340 21 CFR 56.108(a)(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, *** 2
7343 21 CFR 56.108(b)(3) 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, *** 2
7406 21 CFR 56.109(a) Scope of reviews The IRB does not review all research activities covered by the regulations. Specifically, *** 2
7453 21 CFR 312.56(b) 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, *** 2
7456 21 CFR 312.57(d) Bioequivalence samples "Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were not [retained] [released to FDA upon request as required by 21 CFR Part 320.38]. Specifically, ***" 2
7652 21 CFR 56.113 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, *** 2
7657 21 CFR 50.25(b)(5) 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, *** 2
7666 21 CFR 50.20 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, *** 2
7378 21 CFR 50.27(a) Copy of consent form not provided A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent. Specifically, *** 1
7380 21 CFR 50.27(b)(2) Short form: IRB approval of oral presentation The IRB did not approve a written summary of what was to be said to the subject or the subject's legally authorized representative, in a situation where a short form written consent document was prepared. Specifically, *** 1
7397 21 CFR 50.24(a)(5) 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,*** 1
3900 21 CFR 58.10 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, *** 1
3905 21 CFR 58.29(d) Personnel: sanitation and health precautions Not all personnel take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems. Specifically, *** 1
3915 21 CFR 58.31(g) 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, *** 1
3917 21 CFR 58.33 study director: overall study responsibility The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control. Specifically, *** 1
3918 21 CFR 58.33(a) Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, *** 1
3919 21 CFR 58.33(b) 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, *** 1
3922 21 CFR 58.33(e) Study director: follow GLP regulations The study director failed to assure that all applicable GLP regulations were followed. Specifically, *** 1
3931 21 CFR 58.35(b)(5) 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, *** 1
3932 21 CFR 58.35(b)(6) 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, *** 1
3951 21 CFR 58.51 Facility: archives Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, *** 1
3953 21 CFR 58.63(a) Equipment: inspection, cleaning and maintenance Not all equipment is adequately inspected, cleaned, and maintained. Specifically, *** 1
3954 21 CFR 58.63(a) Equipment: calibration Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, *** 1
3955 21 CFR 58.63(b) Equipment: maintenance SOPs The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate. Specifically, *** 1
3958 21 CFR 58.81(a) 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, *** 1
3986 21 CFR 58.105(c) Test article: storage container labeling Not all storage containers for a test or control article were labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Specifically, *** 1
3989 21 CFR 58.107 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, *** 1
3996 21 CFR 58.120(a)(3) 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, *** 1
3999 21 CFR 58.120(a)(6) Protocol: experimental design Not all protocols contained a description of the experimental design, including the methods for the control of bias. Specifically, *** 1
4004 21 CFR 58.120(a)(11) Protocol: date and signature Not all protocols contained the date of approval of the protocol by the sponsor and the dated signature of the study director. Specifically, *** 1
4006 21 CFR 58.120(b) 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, *** 1
4017 21 CFR 58.185(a)(1) Final report: name, address, dates The final study report did not include the name and address of the facility performing the study and the dates on which the study was initiated and completed. Specifically, *** 1
4022 21 CFR 58.185(a)(6) Final report: description of methods The final study report did not include a description of the methods used. Specifically, *** 1
4031 21 CFR 58.185(b) Final report: not signed by study director Not all final reports were signed and dated by the study director. Specifically, *** 1
4035 21 CFR 58.190(a) 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, *** 1
7229 21 CFR 50.27(b)(1) Adequate opportunity to read before signing The investigator did not give [the subject] [the subject's legally authorized representative] adequate opportunity to read the informed consent document before it was signed. Specifically, *** 1
7276 21 CFR 56.107(c) 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, *** 1
7305 21 CFR 56.110(b)(2) 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, *** 1
7319 21 CFR 56.115(a)(3) Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities. Specifically, *** 1
7322 21 CFR 56.111 (a)(2) 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, *** 1
7326 21 CFR 56.111(a)(6) Monitoring of data collected The IRB approved the conduct of research, but did not determine, where appropriate, that the research plan made adequate provisions for monitoring the data collected to ensure the safety of subjects. Specifically, *** 1
7363 21 CFR 50.55(f) 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, *** 1
7366 21 CFR 50.55(e)(1) One parent's permission: studies under Parts 50.51 - 50.52 The IRB had not determined that the permission of one parent was sufficient for a clinical investigation to be conducted on children under the provisions of [21 CFR 50.51] [21 CFR 50.52], yet the investigator did not always obtain the permission of both parents where feasible. Specifically, *** 1
7409 21 CFR 312.53(b) Shipment to unauthorized persons Shipment of an investigational new drug to someone not an investigator participating in the investigation. Specifically, *** 1
7410 21 CFR 312.53(a) Investigator selection "Investigators who were not qualified by training and experience as appropriate experts were selected to investigate a drug. Specifically, ***" 1
7452 21 CFR 312.56(c) IND safety report Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report. Specifically, *** 1
7459 21 CFR 312.57(a) Records of receipt, shipment, disposition Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, *** 1
7461 21 CFR 312.58(a) FDA access to sponsor records "Failure to permit FDA to [have access to] [review] [copy] records or reports related to a clinical investigation. Specifically, ***" 1
7479 21 CFR 312.56(a) Monitoring investigations "Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***" 1
7480 21 CFR 312.50 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, *** 1
7483 21 CFR 312.55(b) New observations, adverse effects and risks "Not all participating investigators were [promptly] informed of new observations discovered by or reported to the sponsor [with respect to adverse effects and safe use]. Specifically, ***" 1
7518 21 CFR 312.64(d) Financial info "Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor. Specifically, ***" 1
7527 21 CFR 312.62(a) Unused drug disposition (investigator) "Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions]. Specifically, *** " 1
7534 21 CFR 312.68 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, ***" 1
7545 21 CFR 312.120(c) 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, ***" 1
7554 21 CFR 312.53(c)(4) Financial information - sufficient and accurate Failure to obtain from an investigator [sufficient] [accurate] financial information to allow complete and accurate certification or disclosure statements. Specifically, *** 1
7556 21 CFR 312.56(b) Shipments after termination of investigator Drug shipments to an investigator were not discontinued after the investigator's participation in the investigation was terminated for noncompliance. Specifically, *** 1
7558 21 CFR 312.57(c) 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*** 1
7629 21 CFR 312.56(c) 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, *** 1
7632 21 CFR 312.6(a) Required label statement The immediate package of the investigational new drug does not bear a label with the statement "Caution: New Drug- Limited by Federal (or United States) law to investigational use 1
7638 21 CFR 312.20(a) 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,*** 1
7639 21 CFR 312.20(b) Starting a study before IND is in effect The sponsor began a clinical investigation subject to IND requirements before an IND was in effect. Specifically,*** 1
7640 21 CFR 312.20(c) IND for emergency research The sponsor failed to [submit a separate IND to] [obtain prior written authorization from] the FDA for a clinical investigation involving an exception from informed consent under 21 CFR 50.24. Specifically,*** 1
7654 21 CFR 56.110(b) 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, *** 1
7665 21 CFR 50.20 Exculpatory language, waiving of rights The general requirements for informed consent were not met in that the consent form contained exculpatory language [through which the subject or the subject's representative was made to waive or appear to waive some of the subject's legal rights] [that released or appeared to release the investigator, sponsor, the institution, or its agents from liability for negligence]. Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
76 21 CFR 606.100(b) 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, *** 77
154 21 CFR 606.160(a)(1) 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, *** 23
98 21 CFR 606.100(c) 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,***" 21
9225 21 CFR 606.171 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, *** 20
155 21 CFR 606.160(b) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, *** 16
160 21 CFR 606.160(a)(1) 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, *** 16
4425 21 CFR 606.60(a) 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, *** 11
67 21 CFR 606.65(e) Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, *** 10
77 21 CFR 606.100(b) 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, *** 8
78 21 CFR 606.100(c) 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, *** 8
159 21 CFR 606.160(a)(1) Legibility and indelibility Records are [illegible] [not indelible]. Specifically, *** 8
31 21 CFR 606.20(b) 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, *** 7
41 21 CFR 606.40(a)(1) Provide space for examination "Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors. Specifically, ***" 7
15030 21 CFR 606.60(b) 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, *** 6
57 21 CFR 606.60(a) 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, *** 5
161 21 CFR 606.160(a)(2) 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, *** 5
9086 21 CFR 600.14(a)(1) Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports]. Specifically, *** 5
9089 21 CFR 600.14(c) When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, *** 5
61 21 CFR 606.60(a) 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, *** 4
89 21 CFR 606.100(b)(10) 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, *** 4
94 21 CFR 606.100(b)(15) 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, *** 4
150 21 CFR 606.151(e) 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, *** 4
208 21 CFR 640.3(a)(1) 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, *** 4
35 21 CFR 606.40 Clean & orderly Failure to maintain facilities in a clean and orderly manner. Specifically, *** 3
92 21 CFR 606.100(b)(13) Procedures to relate blood from donor to final disposition The standard operating procedure fails to include a written description of the procedures used for relating a unit of blood or blood component from the donor to its final disposition. Specifically, *** 3
117 21 CFR 606.121(f) 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, *** 3
224 21 CFR 640.4(f) Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, *** 3
246 21 CFR 640.25(a) 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, *** 3
12203 21 CFR 606.170(a) Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically, 3
50 21 CFR 606.40(c) Provide adequate handwashing Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel. Specifically, *** 2
84 21 CFR 606.100(b)(5) 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, *** 2
91 21 CFR 606.100(b)(12) Criteria for suitability of reissue of returned blood The standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for reissue. Specifically, *** 2
157 21 CFR 606.160(d) Retention period Failure to retain records [for 10 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, *** 2
162 21 CFR 606.165(a) 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, *** 2
238 21 CFR 640.11(a) General requirements - storage Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, *** 2
9044 21 CFR 600.10(b) 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, *** 2
9087 21 CFR 600.14(a)(1) Who must report - receiving information Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed biological product subject to biological product deviation reporting. Specifically, *** 2
9234 21 CFR 630.6(c) 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, *** 2
9235 21 CFR 630.6(c) 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, *** 2
65 21 CFR 606.65(c) Testing of representative samples of reagent lots Representative samples of each lot of [Anti-human globulin] [Blood grouping reagents] [Lectins] [Antibody screening and reverse grouping cells] [Hepatitis test reagents] [Syphilis serology reagents] [Enzymes] are not tested on a regularly scheduled basis as described in the SOP Manual to determine their capacity to perform as required by the regulations. Specifically, *** 1
80 21 CFR 606.100(b)(1) Donor criteria "The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria. Specifically, ***" 1
88 21 CFR 606.100(b)(9) 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, *** 1
110 21 CFR 606.120(b)(2) Destruction of obsolete labels Failure to destroy stocks of obsolete labels. Specifically, *** 1
143 21 CFR 606.140(b) 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, *** 1
144 21 CFR 606.140(c) Adequate identification and handling of test samples Failure to adequately provide for identification and handling of all test samples so that they are accurately related [to the specific unit of product being tested] [to its donor] [to the specific recipient]. Specifically, *** 1
158 21 CFR 606.160(e) 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, *** 1
166 21 CFR 606.170(a) Adverse reaction - Disposition of Reports Written reports of a product at fault in causing a transfusion reaction are not [forwarded to] [maintained by] the [manufacturer] [collecting facility]. Specifically, *** 1
167 21 CFR 606.170(b) 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, *** 1
181 21 CFR 610.53(c) Dating periods for licensed biological products Failure to assign dating periods in accordance with 21 CFR 610.53 or as approved by CBER. Specifically, *** 1
205 21 CFR 640.3(f) 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, *** 1
251 21 CFR 640.25(b) 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, *** 1
253 21 CFR 640.25(b)(4) 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, *** 1
255 21 CFR 640.31 Donor suitability Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, *** 1
260 21 CFR 640.31(b) Criteria for plasmapheresis donor suitability Failure of a plasmapheresis donor to [meet the same criteria for donor suitability as specified for Source Plasma donors (21 CFR 640.63)] [be presented the informed consent]. Specifically, *** 1
321 21 CFR 640.63(c)(6) Weight Donor did not weigh 110 pounds or more on the date of donation. Specifically, *** 1
333 21 CFR 640.64(e) Prevention of contamination The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, *** 1
338 21 CFR 640.65(b)(2)(i) Physician review of four month sample Failure of the physician or physician substitute to [review] [sign] the [plasma or serum protein electrophoresis data] [collection records] within 21 days after the sample was drawn. Specifically, *** 1
343 21 CFR 640.65(b)(3) 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, *** 1
368 21 CFR 640.72(d) Donor reaction Failure of the donor record to contain a full explanation of a donor reaction, while on the plasmapheresis premises or reported to the center after the donor has left the premises, including the measures taken to assist the donor and the outcome of the incident. Specifically, *** 1
370 21 CFR 640.72(a)(2) Donor exams, tests, lab data, interviews Failure to maintain for each donor a separate and complete records of all initial and periodic examinations, tests, laboratory data and interviews. Specifically, *** 1
3244 21 CFR 640.61 Written consent Failure to obtain written consent of prospective Source Plasma donors. Specifically, *** 1
3248 21 CFR 640.63(a) Determining donor suitability Failure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision]. Specifically, *** 1
3455 21 CFR 601.12(f)(1) Labeling changes Failure to [submit a supplement] [receive FDA approval] before distributing the product with labeling changes. Specifically, *** 1
9052 21 CFR 600.11(b) Equipment There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use]. Specifically, *** 1
9078 21 CFR 600.12(a) Maintenance - tracing Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced. Specifically, *** 1
9095 21 CFR 600.80(c)(1)(i) Reporting Requirements - 15-day alert All [serious] [unexpected] adverse experiences were not reported within 15 calendar day of initial receipt of the information. Specifically, *** 1
9097 21 CFR 600.15 Blood & Blood Components Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 °C or colder] [Cryoprecipitated AHF at -18 °C or colder] [Liquid Plasma at 1 to 10 °C] [Plasma at -18 °C or colder] [Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the labeled range] [Red Blood Cells between 1 and 10 °C] [Red Blood Cells, Frozen at -65 °C or colder] [Source Plasma at -5 °C or colder] [Source Plasma Liquid at 10 °C or colder] [Whole Blood as required]. Specifically, *** 1
9219 21 CFR 606.100(b)(20) Donor deferral The standard operating procedure fails to include a written description of the donor deferral process. Specifically, *** 1
9266 21 CFR 610.40(e) Further testing Failure to further test each donation found to be reactive to a screening test. Specifically, *** 1
9305 21 CFR 640.66 Procedures Failure to maintain immunization procedures on site. Specifically, *** 1
9596 21 CFR 640.3(a) 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, *** 1
12202 21 CFR 606.170(a) Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made. Specifically, 1
15033 21 CFR 610.47(a) Lookback System [Collecting Establishment] Failure to [establish] [maintain] [follow] an appropriate system for HCV "lookback." Specifically, *** 1
15034 21 CFR 610.47(a)(1) Review Records ID Previous Donations [Collecting Estab] Failure to review all records required under the regulations to identify previously donated blood and blood components within 3 calendar days [after a donor tests reactive for evidence of HCV infection] [when you were made aware of other reliable test results] [when you were made aware of information] indicating evidence of HCV infection. Specifically, *** 1
15064 21 CFR 610.46(a) "Lookback System [Collecting Establishment]" Failure to [establish] [maintain] [follow] an appropriate system for HIV "lookback." Specifically, *** 1
15065 21 CFR 610.46(a)(1) Review Records to ID Previous Donations [Collecting Estab] Failure to review all records required under the regulations to identify previously donated blood and blood components within 3 calendar days [after a donor tests reactive for evidence of HIV infection] [when you were made aware of other reliable test results] [when you were made aware of information] indicating evidence of HIV infection. Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
12416 21 CFR 1271.260(e) Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, *** 16
12213 21 CFR 1271.47(a) 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, *** 14
12277 21 CFR 1271.75(a)(1) 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, *** 14
12336 21 CFR 1271.180(a) 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, *** 14
12431 21 CFR 1271.265(e) 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, *** 14
12229 21 CFR 1271.50(a) 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, *** 12
12286 21 CFR 1271.80(b) Specimen collections not timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time. Specifically, *** 12
12492 21 CFR 1271.85(a) Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents. Specifically, *** 10
12230 21 CFR 1271.50(a) 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, *** 9
12246 21 CFR 1271.55(d)(1)(iii) 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, *** 9
12433 21 CFR 1271.265(f) 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, *** 9
12221 21 CFR 1271.47(a) 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, *** 7
12432 21 CFR 1271.265(e) 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, *** 7
12457 21 CFR 1271.320(a) 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, *** 7
12242 21 CFR 1271.55(c) 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, *** 6
12247 21 CFR 1271.55(d)(2) Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible]. Specifically, *** 6
12287 21 CFR 1271.80(c) 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, *** 6
12493 21 CFR 1271.90(b) 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, *** 6
12223 21 CFR 1271.47(b) Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation. Specifically, *** 5
12282 21 CFR 1271.75(d) 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, *** 5
12301 21 CFR 1271.150(c)(1)(iii) 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, *** 5
12398 21 CFR 1271.230(a) 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, *** 4
12222 21 CFR 1271.47(a) Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically, *** 3
12239 21 CFR 1271.55(b)(2) Listing and interpretation of CD tests performed The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed. Specifically, *** 3
12254 21 CFR 1271.60(b) Identified as quarantined, distinguishable HCT/Ps in quarantine pending completion of the donor eligibility determination were [not clearly identified as quarantined] [not easily distinguishable from HCT/Ps available for release and distribution]. Specifically, *** 3
12272 21 CFR 1271.65(b)(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, *** 3
12278 21 CFR 1271.75(a)(2) Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation. Specifically, *** 3
12311 21 CFR 1271.160(b)(1) 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, *** 3
12334 21 CFR 1271.170(c) Trained or re-trained as necessary Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities. Specifically, *** 3
12369 21 CFR 1271.200(b) Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, *** 3
12411 21 CFR 1271.260(a) 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, *** 3
12414 21 CFR 1271.260(d) Corrective actions Corrective actions were not [performed] [documented] when proper storage conditions were not met. Specifically, *** 3
12417 21 CFR 1271.260(e) Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits. Specifically, *** 3
12436 21 CFR 1271.270(a) Accurate, indelible, legible Records were not [accurate] [indelible] [legible]. Specifically, *** 3
12496 21 CFR 1271.85(b)(2) SOP for release; reactive for CMV A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically. *** 3
15020 21 CFR 1271.200(e) Documentation of maintenance and cleaning Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained. Specifically, *** 3
12232 21 CFR 1271.50(b)(2) 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, *** 2
12241 21 CFR 1271.55(b)(4) Reasons for ineligibility on summary The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility. Specifically, *** 2
12243 21 CFR 1271.55(d)(1) Documentation maintained (general) Documentation was not maintained after the donor-eligibility determination was complete. Specifically, *** 2
12270 21 CFR 1271.65(a) Improper release prevention--storage, I.D. HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release. Specifically, *** 2
12280 21 CFR 1271.75(c) Reproductive cells/ tissues- general Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of communicable diseases of the genitourinary tract. Specifically, *** 2
12290 21 CFR 1271.80(d)(1) Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible. Specifically, *** 2
12310 21 CFR 1271.160(a) 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, *** 2
12325 21 CFR 1271.160(b)(6) 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, *** 2
12326 21 CFR 1271.160(c) Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed. Specifically, *** 2
12337 21 CFR 1271.180(a) 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, *** 2
12345 21 CFR 1271.190(b)(1) Clean, sanitary, orderly manner Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction, transmission, or spread of communicable disease. Specifically, *** 2
12353 21 CFR 1271.190(d)(1) Description of methods, schedule Facility cleaning and sanitation procedures did not describe [the cleaning methods to be used] [the schedule for cleaning]. Specifically, *** 2
12363 21 CFR 1271.195(c) Monitoring--cross contamination, exposure to CD Environmental conditions are not monitored when such conditions could cause [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents]. Specifically, *** 2
12370 21 CFR 1271,200(c) 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, *** 2
12387 21 CFR 1271.220(a) 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, *** 2
12415 21 CFR 1271.260(e) 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, *** 2
12429 21 CFR 1271.265(d) Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, *** 2
12435 21 CFR 1271.270(a) Records maintained concurrently Records were not maintained concurrently with the performance of each step. Specifically, *** 2
12447 21 CFR 1271.290(b) 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, **** 2
12459 21 CFR 1271.320(b) Sufficient information to draw conclusions The complaint file [did not contain sufficient information about each complaint for proper review and evaluation] [did not include the distinct identification code of the HCT/P involved] [did not contain sufficient information for determining whether the complaint is an isolated event or represents a trend]. Specifically, *** 2
12224 21 CFR 1271.47(c) Availability of procedures Donor eligibility procedures were not available to personnel in the area where operations are performed, or in a nearby area when such availability is impractical. Specifically, *** 1
12231 21 CFR 1271.50(b)(1) 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, *** 1
12237 21 CFR 1271.55(a)(3) 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, *** 1
12238 21 CFR 1271.55(b)(1) 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, *** 1
12249 21 CFR 1271.55(d)(3) Records not made available to FDA Required donor eligibility records were not made available for authorized inspection or upon request by FDA. Specifically, *** 1
12279 21 CFR 1271.75(b) 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, *** 1
12281 21 CFR 1271.75(c) Reproductive cells/tissues-Chlamydia, Neisseria Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of [Chlamydia trachomatis] [Neisseria gonorrhea]. Specifically, *** 1
12283 21 CFR 1271.75(e) 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, *** 1
12285 21 CFR 1271.80(a) Birth mother sample not tested A sample from the birth mother of a donor one month of age or younger was not used for testing of communicable disease agents. Specifically, *** 1
12288 21 CFR 1271.80(c) Manufacturer instructions not followed Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions. Specifically, *** 1
12291 21 CFR 1271.80(d)(2) 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, *** 1
12312 21 CFR 1271.160(b)(2) 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. 1
12319 21 CFR 1271.160(b)(3) Actions taken and documented The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented]. Specifically, *** 1
12320 21 CFR 1271.160(b)(3) 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, *** 1
12322 21 CFR 1271.160(b)(4) Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities. Specifically, *** 1
12323 21 CFR 1271.160(b)(5) Monitoring systems The quality program has not established and maintained appropriate monitoring systems. Specifically, *** 1
12324 21 CFR 1271.160(b)(6) 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, *** 1
12332 21 CFR 1271.170(b) Qualifications lacking Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions. Specifically, *** 1
12359 21 CFR 1271.195(a)(3) Aseptic processing---cleaning, disinfecting Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing. Specifically, *** 1
12361 21 CFR 1271.195(b) Periodic inspection Environmental control systems are not periodically inspected to verify adequate and proper function. Specifically, *** 1
12365 21 CFR 1271.195(d) Documentation not maintained Documentation of environmental control and monitoring activities was not maintained. Specifically, *** 1
12367 21 CFR 1271.200(a) Design appropriate, suitably located Equipment used in the manufacture of HCT/Ps was [not of appropriate design for its use] [not suitably located to facilitate operations, cleaning and maintenance]. Specifically, *** 1
12378 21 CFR 1271.210(d)(1) Receipt documentation maintained Documentation of the receipt of [supplies] [reagents] was not maintained. Specifically, *** 1
12395 21 CFR 1271.225 Verification/validation Process changes were not [validated] [verified] to ensure the change does not cause an adverse impact elsewhere in operations. Specifically, *** 1
12399 21 CFR 1271.230(a) 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, *** 1
12405 21 CFR 1271.250(a) 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, *** 1
12406 21 CFR 1271.250(a) Design of labeling procedures Labeling procedures were not designed [to ensure proper HCT/P identification] [to prevent mix-ups]. Specifically, *** 1
12407 21 CFR 1271.250(b) Verification of label accuracy, legibility, integrity Labeling procedures did not include verification of label [accuracy] [legibility] [integrity]. Specifically, *** 1
12421 21 CFR 1271.265(a) 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, *** 1
12424 21 CFR 1271.265(c)(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, *** " 1
12437 21 CFR 1271.270(a) 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, *** 1
12438 21 CFR 1271.270(b) Management system re: core CGTPs A records management system relating to core CGTP requirements was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, *** 1
12452 21 CFR 1271.290(d) Recording I.D. code and type of HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system to record [the distinct identification code] [the type] of each HCT/P distributed to a consignee. Specifically, *** 1
12453 21 CFR 1271.290(e) 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, *** 1
12460 21 CFR 1271.320(c) 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, *** 1
12468 21 CFR 1271.350(a)(1) Investigation of adverse reactions Adverse reactions involving a communicable disease related to HCT/Ps were not investigated. Specifically, *** 1
12469 21 CFR 1271.350(a)(1) Adverse reaction reporting to FDA Adverse reactions which involved a communicable disease related to an HCT/P made available for distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body, or necessitated medical or surgical intervention, were not reported to FDA. Specifically, *** 1
12470 21 CFR 1271.350(a)(2) 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, *** 1
12473 21 CFR 1271.350(b)(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, *** 1
12489 21 CFR 1271.90(b)(1) Autologous use only--labeling HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only. Specifically, *** 1
12490 21 CFR 1271.85(b)(1) Cell-associated CD Donors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases. Specifically, *** 1
12494 21 CFR 1271.85(c) Reproductive cells or tissues Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for communicable diseases of the genitourinary tract. Specifically, *** 1
15026 21 CFR 1271.85(c) Reproductive cells or tissues-cell-associated CD Donors of viable, leukocyte-rich reproductive cells or tissues were not tested for cell-associated communicable diseases or cytomegalovirus (CMV). Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
7036 21 CFR 1250.67 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, *** 29
7032 21 CFR 1250.63 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, *** 17
6558 21 CFR 1250.30(d) Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, *** 15
6560 21 CFR 1250.32(a) Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, *** 14
6569 21 CFR 1250.33(b) Equipment kept clean Failure to keep all equipment clean. Specifically, *** 11
6552 21 CFR 1250.28 Handling to avoid contamination Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination. Specifically, *** 8
7053 21 CFR 1250.75(b) Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, *** 8
6563 21 CFR 1250.33(a) 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, *** 5
7051 21 CFR 1250.75(a) Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, *** 5
7055 21 CFR 1250.75(b) 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, *** 5
7090 21 CFR 1250.82(e) Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, *** 5
6564 21 CFR 1250.33(a) 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, *** 4
6581 21 CFR 1250.38(b) Soap, sanitary towels, water Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, *** 4
6591 21 CFR 1250.42(a) Backflow protection A water system not protected against backflow. Specifically, *** 4
7042 21 CFR 1250.70(a) Clean and sanitary Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition. Specifically, *** 4
7089 21 CFR 1250.82(d) Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification. Specifically, *** 4
6565 21 CFR 1250.33(a) 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, *** 3
6570 21 CFR 1250.33(c) 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, *** 3
6593 21 CFR 1250.42(b) 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, *** 3
6555 21 CFR 1250.30(a) 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, *** 3
7041 21 CFR 1250.70(a) 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, *** 3
6580 21 CFR 1250.38(b) 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, *** 2
6561 21 CFR 1250.32(b) Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, *** 2
7038 21 CFR 1250.67 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, *** 2
6567 21 CFR 1250.33(b) 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, *** 1
6568 21 CFR 1250.33(b) 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, *** 1
6572 21 CFR 1250.34 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, *** 1
6579 21 CFR 1250.38(a) Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, *** 1
6585 21 CFR 1250.39 Containers - close-fitting covers Garbage containers lack close-fitting covers. Specifically, *** 1
6508 21 CFR 1240.61(a) Not pasteurized Milk or milk product in final package form for direct human consumption has not been pasteurized or made from dairy ingredients that have all been pasteurized. Specifically, *** 1
6509 21 CFR 1240.61(b) Inadequate pasteurization Pasteurization of [milk] [milk products] does not meet minimum time-temperature requirements. Specifically, *** 1
6512 21 CFR 1240.62(b) Undersized live turtles Live turtles with a carapace length of less than four inches [sold] [held for sale] [offered for public distribution]. Specifically, *** 1
6549 21 CFR 1250.27 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, *** 1
6554 21 CFR 1250.30(a) Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, *** 1
6609 21 CFR 1250.49 Clean and free of flies and mosquitoes Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit. Specifically, *** 1
7037 21 CFR 1250.67 Outlets for non-potable water Outlets for non-potable water have not been provided with fittings different from those provided for outlets for potable water. Specifically, *** 1
7087 21 CFR 1250.82(c) Potable water tanks -- openings A potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating substances. Specifically, *** 1
7120 21 CFR 1250.95 Infestation by flies, mosquitoes, fleas, lice, other insects Failure to prevent, through generally accepted methods of control, an infestation by [flies] [mosquitoes] [fleas] [lice] [insects known to be vectors in the transmission of communicable diseases]. Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
5007 21 CFR 1002.13 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, *** 8
5005 21 CFR 1002.11 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, *** 3
5700 21 CFR 1002.10 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, *** 2
5802 21 CFR 1002.13 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, *** 2
5813 21 CFR 1002.30(a)(2) Methods, devices, procedures for testing You have not [established] [maintained] records of the [methods] [devices] [procedures] used in tests for electronic product radiation safety. Specifically, *** 2
5816 21 CFR 1002.30(a)(4) Communication with dealers et. al. You have not [established] [maintained] copies of all written communication between you and dealers, distributors, and purchasers concerning radiation safety, including [complaints] [investigations] [instructions] [explanations affecting the use, repair, adjustment, maintenance, or testing] for your products listed under 21 CFR 1002.1. Specifically, *** 2
5741 21 CFR 1020.33(h)(1) Visual indication of x-ray production, shutter status There is no visual indication [on the control] [near the housing of the scanning mechanism] of a computed tomography system that [x-rays are being produced] [the shutter is open or closed]. Specifically, *** 1
5748 21 CFR 1020.33(f)(1) Visible from any position Indications of CT conditions of operation are not visible from all positions from which scan initiation is possible. Specifically, *** 1
5008 21 CFR 1002.20(a) Failure to report You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you. Specifically, *** 1
5012 21 CFR 1003.10(a) FDA not notified of defect or noncompliance You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled] [imported] [distributed]. Specifically, *** 1
5032 21 CFR 1010.2(b) 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, *** 1
5034 21 CFR 1010.2(c) 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, *** 1
5044 21 CFR 1010.3(a)(2) ID label lacks place, month & year of manufacture An identification label fails to provide the [place] [month] [year] of manufacture. Specifically, *** 1
5066 21 CFR 1020.40(c)(1)(i) Leakage limit Radiation emitted from a cabinet x-ray system exceeds an exposure of 0.5 milliroentgen in one hour, measured at a point five centimeters outside the external surface. Specifically, *** 1
5104 21 CFR 1020.40(c)(9)(ii) Purchaser-assembled/installed systems Failure to provide the purchaser of a cabinet x-ray system with instructions for [assembly] [installation] [adjustment] [testing] adequate to assure that the system is in compliance when assembled, installed, adjusted, and tested as directed. Specifically, *** 1
5144 21 CFR 1040.10(f)(2)(i) 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, *** 1
5197 21 CFR 1040.10(h)(1)(i) User information, adequate instructions Adequate instructions for each laser product were not provided or caused to be provided for [assembly] [operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits specified in the regulations] [a maintenance schedule necessary to keep the product in compliance with the standard]. Specifically, *** 1
5203 21 CFR 1040.10(h)(2)(i) 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, *** 1
5450 21 CFR 1020.30(h)(2)(i) Tube housing assemblies (leakage technique factors) Failure to provide the purchaser or to others upon request at cost, [statements of the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which you state compatibility] [the minimum filtration permanently in the useful beam expressed as millimeters of aluminum equivalent] [the peak tube potential at which the aluminum equivalent was obtained]. Specifically, *** 1
5472 21 CFR 1020.30(k) Compliance measurements--diagnostic source assembly Compliance for radiation leakage from the diagnostic source assembly was not determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. Specifically, *** 1
5690 21 CFR 1002.10(g) 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, *** 1
5709 21 CFR 1002.40(b) Purchaser, product info, date of sale The information which you have obtained regarding first purchasers lacks the [name and mailing address of the purchaser] [identification and brand name of the product] [model number and serial or other identification number of the product] [date of sale, award, or lease]. Specifically, *** 1
5817 21 CFR 1002.30(a)(5) Production and sales volume levels You have not [established] [maintained] records containing data on production and sales volume levels. Specifically, *** 1
5907 21 CFR 1020.30(d)(1) Report of assembly submitted within 15 days A completed report of assembly regarding certified components installed in a diagnostic x-ray system was not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation protection] within 15 days following the completion of the assembly. Specifically, *** 1

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