Inspections, Compliance, Enforcement, and Criminal Investigations

FY 2006 Inspectional Observation Summaries

Number of 483s issued from the System*

Inspections ending between 10/1/2005 12:00:00 AM and 9/30/2006 12:00:00 AM

Center Name 483s issued
Foods 2452
Devices 887
Drugs 649
Incidental text 418
Bioresearch monitoring 286
Veterinary medicine 202
Biologics 299
Parts 1240 and 1250 204
Human tissue for transplantation 86
Radiological health 2
Special requirements 12
Sum Product Area 483s from System* 5497
Actual Total in system 483s** 4849

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

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

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Foods

Center Name Cite Id Ref No Frequency Short Description Long Description
Foods 905 21 CFR 123.6(b) 364 HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, ***
1524 21 CFR 123.11(b) 323 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, ***
1560 21 CFR 110.35(c) 263 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, ***
904 21 CFR 123.6(b) 258 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, ***
1525 21 CFR 123.11(c) 250 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, ***
12720 21 CFR 1.225 249 Not registered Your food facility is not registered as required. Specifically, ***
945 21 CFR 123.12(a)(2) 238 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, ***
908 21 CFR 123.6(d) 210 Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, ***
6004 21 CFR 123.6(c)(4) 204 Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically***
961 21 CFR 123.6(c)(3) 195 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,
6008 21 CFR 123.8(a)(3) 186 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, ***
960 21 CFR 123.6(c)(2) 165 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, ***
1422 21 CFR 110.20(b)(4) 145 Floors, walls and ceilings The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good repair]. Specifically, ***
1552 21 CFR 110.35(a) 140 Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
6020 21 CFR 123.9(a) 139 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, ***
963 21 CFR 123.6(c)(5) 136 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***
1553 21 CFR 110.35(a) 135 Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, ***
1306 21 CFR 110.20(b)(7) 131 Screening Failure to provide adequate screening or other protection against pests. Specifically, ***
1287 21 CFR 110.20(a)(1) 119 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, ***
6021 21 CFR 123.10 119 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, ***
959 21 CFR 123.6(c)(1) 117 Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
1695 21 CFR 110.80(b)(2) 113 Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination]. Specifically, ***
933 21 CFR 123.8(a)(2)(ii) 110 Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
2386 21 CFR 110.80(a)(1) 101 Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, ***
6001 21 CFR 123.11(b) 98 Sanitation monitoring documentation Your sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically***
1554 21 CFR 110.35(a) 95 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, ***
1701 21 CFR 110.80(b)(7) 94 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, ***
1424 21 CFR 110.20(b)(4) 92 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, ***
1405 21 CFR 110.10(b)(6) 89 Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, ***
990 21 CFR 110.10(b)(3) 84 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, ***
1007 21 CFR 110.10(b)(9) 83 Precautions against contamination--micro, foreign substances Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
1427 21 CFR 110.20(b)(5) 81 Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, ***
6005 21 CFR 123.6(c)(6) 76 Verification procedures - adequacy Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented. Specifically, ***
1173 21 CFR 110.40(f) 75 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,***
1615 21 CFR 110.93 74 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination. Specifically, ***
6018 21 CFR 123.7(a) 74 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,***
2392 21 CFR 110.80(b)(1) 73 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, ***
1689 21 CFR 110.80 72 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
9930 21 CFR 120.6(c) 72 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, ***
3659 21 CFR 110.37(e)(3) 70 Hand drying Lack of a sanitary towel service or suitable hand drying devices. Specifically, ***
1006 21 CFR 110.10(b)(8) 67 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, ***
1556 21 CFR 110.35(b)(2) 67 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, ***
931 21 CFR 123.8(d) 66 Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***
1562 21 CFR 110.35(d) 66 Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, ***
6015 21 CFR 123.6(c)(6) 64 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, ***
913 21 CFR 123.8(a)(1) 58 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, ***
1292 21 CFR 110.20(b)(1) 58 Sufficient space Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for the maintenance of sanitary operations and the production of safe food. Specifically, ***
1597 21 CFR 110.37(b)(3) 58 As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, ***
1581 21 CFR 110.37(e) 55 Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature. Specifically, ***
1126 21 CFR 110.40(a) 54 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, ***
6007 21 CFR 123.9(a) 52 Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed. Specifically, ***
901 21 CFR 123.6(a) 51 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, ***
3661 21 CFR 110.37(e)(5) 51 Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, ***
9941 21 CFR 120.8(a) 51 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, ***
906 21 CFR 123.6(b) 50 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, ***
1172 21 CFR 110.40(e) 50 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, ***
6006 21 CFR 123.6(c)(7) 49 Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, ***
1125 21 CFR 110.40(a) 48 Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, ***
1402 21 CFR 110.10(b)(4) 48 Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, ***
1696 21 CFR 110.80(b)(3) 46 Holding foods - refrigerate/freeze/heat Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. Specifically, ***
1599 21 CFR 110.37(b)(5) 45 Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
4470 21 CFR 108.25(c)(2) 44 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, ***
9935 21 CFR 120.7(a) 44 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, ***
3652 21 CFR 110.37(e)(1) 43 Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, ***
1571 21 CFR 110.35(d)(5) 42 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, ***
3658 21 CFR 110.37(e)(2) 42 Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
6019 21 CFR 123.8(a)(2) 42 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, ***
9931 21 CFR 120.6(b) 42 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, ***
9958 21 CFR 120.12(c) 42 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, ***
3654 21 CFR 110.37(d)(1) 41 Maintained Failure to maintain toilet facilities in a sanitary condition. Specifically, ***
985 21 CFR 110.10(b)(1) 40 Suitable outer garments Suitable outer garments are not worn that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
6010 21 CFR 123.8(a)(3)(i) 40 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, ***
1406 21 CFR 110.10(b)(6) 39 Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, ***
1066 21 CFR 110.40(b) 37 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, ***
1570 21 CFR 110.35(d)(5) 36 Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
1698 21 CFR 110.80(b)(5) 36 Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
1702 21 CFR 110.80(b)(8) 36 Metal / extraneous materials Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, ***
6022 21 CFR 123.12(c) 36 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, ***
950 21 CFR 123.12(d) 35 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, ***
1005 21 CFR 110.10(b)(7) 35 Storage of personal items Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils are washed]. Specifically, ***
12734 21 CFR 120.12(a) 35 Required records 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, ***
3080 21 CFR 114.83 33 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, ***
6016 21 CFR 123.6(c)(7) 33 Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, ***
1293 21 CFR 110.20(b)(2) 32 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, ***
1578 21 CFR 110.37(f) 32 Odor, attractant for pests, harborage The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor] [potential for waste becoming an attractant and harborage or breeding place for pests]. Specifically, ***
3086 21 CFR 114.100(b) 32 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, ***
9932 21 CFR 120.6(a) 32 No SSOP 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, ***
12742 21 CFR 120.8(a) 32 HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, ***
932 21 CFR 123.7(d) 31 Corrective action documentation You do not have records that document corrective actions that were taken. Specifically, ***
1565 21 CFR 110.35(d)(3) 29 Non-food-contact surfaces (S) Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, ***
3085 21 CFR 114.100(a) 29 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, ***
1403 21 CFR 110.10(b)(4) 28 Hand jewelry - remove/cover Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand. Specifically, ***
1426 21 CFR 110.20(b)(5) 28 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, ***
6014 21 CFR 123.6(c)(2) 26 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,
9955 21 CFR 120.11(a)(1) 26 Verification activities 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, ***
12749 21 CFR 120.8(b)(6) 26 Verification procedures - none/frequency Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented. Specifically, ***
12755 21 CFR 120.11(a)(1)(iv) 26 Records review signed 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, ***
1289 21 CFR 110.20(a)(3) 25 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, ***
1709 21 CFR 110.80(b)(13) 25 Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, ***
9984 21 CFR 120.13(a) 25 Training requirements DO NOT CITE. See Notes for more information.

918 21 CFR 123.8(a) 23 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, ***
1602 21 CFR 110.37(a) 23 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, ***
3656 21 CFR 110.37(d)(3) 23 Self-closing doors Toilet facilities lack self-closing doors. Specifically, ***
4479 21 CFR 108.25(e) 23 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, ***
1598 21 CFR 110.37(b)(4) 22 Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, ***
3643 21 CFR 110.10(b)(5) 22 Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, ***
9928 21 CFR 120.12(b) 22 General records requirements 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, ***
12747 21 CFR 120.8(b)(3) 22 Critical limits 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, ***
1067 21 CFR 110.40(c) 21 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, ***
1429 21 CFR 110.20(b)(6) 20 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, ***
6009 21 CFR 123.8(a)(3)(iii) 20 Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, ***
4464 21 CFR 108.25(c)(1) 19 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, ***
9936 21 CFR 120.7(a) 19 Hazard analysis - 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, ***
3078 21 CFR 114.80(b) 18 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, ***
6017 21 CFR 123.7(c) 18 Corrective action per regulation You did not take corrective action that ensured [the affected product was segregated] [a review of the affected product was done to determine its acceptability] [affected product was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation and modified as necessary]. Specifically, ***
9934 21 CFR 120.6(a) 18 SSOP does not address Your sanitation standard operating procedure does not address [the safety of the water that comes into contact with food or food contact surfaces or that is used to manufacture ice] [the condition and cleanliness of food contact surfaces] [the prevention of cross-contamination from insanitary objects] [the maintenance of hand washing, hand sanitizing, and toilet facilities] [the protection of food, food packaging material, and food contact surfaces from adulteration with contaminants] [the proper labeling, storage, and use of toxic compounds] [the control of employee health conditions that could result in microbiological contamination of the food, food packaging materials, and food contact surfaces] [the exclusion of pests from the food plant]. Specifically, ***
9947 21 CFR 120.11(b) 18 HACCP plan - failure to validate 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, ***
12745 21 CFR 120.8(b)(1) 18 Food hazards Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
975 21 CFR 123.9(b)(1) 17 Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically, ***
2393 21 CFR 110.80(b)(1) 17 Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***
3073 21 CFR 114.80(a)(2) 17 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, ***
1128 21 CFR 110.40(a) 16 Installation and maintenance of equipment (S) Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, ***
3071 21 CFR 114.80(a)(1) 16 Scheduled process Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***
3647 21 CFR 110.10(c) 16 Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors]. Specifically, ***
3663 21 CFR 110.40(e) 16 Lack of automatic control / alarm (S) Lack of [an automatic control for regulating temperature] [an automatic temperature alarm system] for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms. Specifically, ***
12743 21 CFR 120.8(b)(4) 15 Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits. Specifically, ***
1184 21 CFR 110.35(e) 14 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, ***
1596 21 CFR 110.37(b)(2) 14 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, ***
3062 21 CFR 114.10 14 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, ***
3712 21 CFR 110.93 14 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, ***
9939 21 CFR 120.7(c) 14 Consideration of hazards 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, ***
9954 21 CFR 120.11(a)(1)(iv) 14 Record review - CCP, CA You did not review [all of] your [critical control point monitoring] [corrective action] records within one week (7 days) of the day the records are made. Specifically, ***
12746 21 CFR 120.8(b)(2) 14 Critical control points Your HACCP plan does not list the critical control points for each of the identified food hazards. Specifically, ***
1129 21 CFR 110.40(a) 13 Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces. Specifically, ***
1711 21 CFR 110.80(b)(15) 13 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, ***
2384 21 CFR 110.80(a)(7) 13 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, ***
2388 21 CFR 110.80(a)(5) 13 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, ***
3067 21 CFR 114.80(a) 13 Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "***
9943 21 CFR 120.8(a) 13 Location and type Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed]. Specifically, ***
12750 21 CFR 120.8(b)(6) 13 Validation procedures - none/frequency 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, ***
1601 21 CFR 110.37(a) 12 Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, ***
2394 21 CFR 110.80(b)(6) 12 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, ***
12751 21 CFR 120.8(b)(7) 12 Recordkeeping system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, ***
929 21 CFR 123.8(b) 11 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, ***
1566 21 CFR 110.35(d)(4) 11 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, ***
1642 21 CFR 113.100(b) 11 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, ***
3655 21 CFR 110.37(d)(2) 11 Good repair Failure to keep toilet facilities in good repair. Specifically, ***
938 21 CFR 123.9(c) 10 Official review You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations. Specifically, ***
1090 21 CFR 110.40(d) 10 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, ***
1561 21 CFR 110.35(c) 10 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, ***
1763 21 CFR 110.35(b)(1) 10 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, ***
1766 21 CFR 110.35(b)(1) 10 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, ***
2361 21 CFR 110.80 10 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
9919 21 CFR 120.10(a) 10 Steps to be taken You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, ***
9957 21 CFR 120.12(a)(4) 10 Records - HACCP system The records you maintain to document the ongoing application of your HACCP plan do not include [the monitoring of critical control points and their limits] [corrective actions]. Specifically, ***
9961 21 CFR 120.24(a) 10 HACCP plan - microorganism 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, ***
986 21 CFR 110.10(b)(2) 9 Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness. Specifically, ***
1425 21 CFR 110.20(b)(4) 9 Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, ***
3657 21 CFR 110.37(d)(4) 9 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, ***
9929 21 CFR 120.12(b)(4) 9 Recorded when observed Processing and other information is not [always] entered on your records at the time it is observed. Specifically, ***
12744 21 CFR 120.8(b)(4) 9 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 limits. Specifically, ***
1697 21 CFR 110.80(b)(4) 8 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, ***
2385 21 CFR 110.80(a)(1) 8 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, ***
3090 21 CFR 114.100(d) 8 Product distribution Records identifying initial distribution of finished product are not maintained. Specifically, ***
1568 21 CFR 110.35(d)(2) 7 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, ***
1641 21 CFR 113.100(b) 7 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, ***
3653 21 CFR 110.37(d) 7 Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
3662 21 CFR 110.37(e)(6) 7 Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, ***
6002 21 CFR 123.11(b) 7 Sanitation corrections You did not correct sanitation deficiencies in a timely manner. Specifically,***
6012 21 CFR 123.8(a)(3)(iii) 7 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, ***
899 21 CFR 123.16 6 Process controls Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
1643 21 CFR 113.100(c) 6 Incomplete information Written records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions taken]. Specifically, ***
2396 21 CFR 110.80(b)(6) 6 Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination. Specifically, ***
3660 21 CFR 110.37(e)(4) 6 Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, ***
9926 21 CFR 120.14(a) 6 Importer verification 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, ***
9981 21 CFR 120.12(b)(4) 6 Actual values Your records do not [always] contain the actual values and observations obtained during monitoring. Specifically, ***
972 21 CFR 123.8(a)(1) 5 Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. Specifically, ***
1288 21 CFR 110.20(a)(2) 5 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, ***
2065 21 CFR 123.28(c) 5 Shellstock records You do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification number of the harvester issued by the shellfish control authority]. Specifically, ***
2275 21 CFR 129.80(g)(2) 5 Chemical, physical, radiological You do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological] testing at least annually [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
2391 21 CFR 110.80(a)(6) 5 Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, ***
3075 21 CFR 114.80(a)(4) 5 Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination. Specifically, ***
3082 21 CFR 114.89 5 Process deviation Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of the finished product higher than 4.6]. Specifically, ***
3093 21 CFR 114.89 5 Process deviation evaluation - record Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, ***
4296 21 CFR 110.80(a)(5) 5 Temperature and humidity Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated. Specifically, ***
4419 21 CFR 110.10(c) 5 Level of competency (S) Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a needed level of competency. Specifically, ***
9917 21 CFR 120.10(c) 5 Corrective action documentation You do not have records that [fully] document corrective actions that were taken. Specifically, ***
9962 21 CFR 120.24(b) 5 Direct treatment - not exempt under 120.24(b) Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply. Specifically, ***
9964 21 CFR 120.25 5 Finished product not analyzed for E.coli You do not [always] analyze your finished juice product for biotype I Escherichia coli. Specifically, ***
12732 21 CFR 120.10(a) 5 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, ***
12754 21 CFR 120.11(a)(1)(iv)(C) 5 Calibration, testing - record review 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, ***
1060 21 CFR 123.11(a) 4 SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, ***
1176 21 CFR 110.40(f) 4 Insufficient number of Q.C. instruments An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms. Specifically,***
1196 21 CFR 110.10(a) 4 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, ***
1330 21 CFR 113.100(a) 4 Processing entry missing information Forms used to record processing or production information lack the [product] [code number] [date] [retort or processing system number] [container size] [approximate number of containers per coding interval] [initial temperature] [actual processing time] [mercury-in-glass thermometer readings] [recording thermometer readings] [appropriate processing data]. Specifically, ***
1577 21 CFR 110.37(f) 4 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, ***
1734 21 CFR 113.40(a)(2) 4 Corresponding with MIG Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
1751 21 CFR 113.40(a)(8) 4 Size, fully open Bleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***
2362 21 CFR 110.80 4 Reject and rework Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination.. Specifically, ***
2387 21 CFR 110.80(a)(1) 4 Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, ***
2389 21 CFR 110.80(a)(5) 4 Identify rework Failure to identify material scheduled for rework as such. Specifically, ***
2848 21 CFR 113.40(g)(1)(i)(b) 4 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, ***
3077 21 CFR 114.80(b) 4 Visible code Each container is not marked with an identifying code permanently visible to the naked eye. Specifically, ***
3088 21 CFR 114.100(b) 4 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, ***
3089 21 CFR 114.100(c) 4 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, ***
3645 21 CFR 110.10(d) 4 Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned to competent supervisory personnel. Specifically, ***
3651 21 CFR 110.37(b)(5) 4 Cross contamination Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, ***
4062 21 CFR 113.100(a) 4 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, ***
4181 21 CFR 113.89 4 Process deviation identification Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control. Specifically, ***
4421 21 CFR 110.20(a) 4 Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
4511 21 CFR 108.25(f) 4 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, ***
4515 21 CFR 108.35(c)(2) 4 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, ***
12709 21 CFR 129.80(c) 4 Records of cleaning/sanitizing solutions You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
12718 21 CFR 120.6(a) 4 Before, during, after processing Your sanitation standard operating procedure does not address sanitation conditions and practices [before] [during] [after] processing. Specifically, ***
12731 21 CFR 120.7(a)(2) 4 Hazard evaluation not complete The evaluation of a food hazard identified in your written hazard analysis [did not determine if the hazard were reasonably likely to occur] [did not include an assessment of the severity of the illness or injury if the food hazard occurred]. Specifically, ***
976 21 CFR 123.9(b)(2) 3 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, ***
1132 21 CFR 110.40(a) 3 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, ***
1255 21 CFR 129.20(a) 3 Bottling room separation The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination. Specifically, ***
1290 21 CFR 110.20(a)(4) 3 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, ***
1534 21 CFR 113.100(b) 3 Entries not done Required entries on [processing records] [production records] were not made by the retort or processing system operator or other designated person for specific retort operations or conditions specified in the scheduled process. Specifically, ***
1569 21 CFR 110.35(d)(2) 3 Continuous operations Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary. Specifically, ***
1600 21 CFR 110.37(a) 3 General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, ***
1669 21 CFR 110.80(a)(3) 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, ***
1670 21 CFR 110.80(a)(4) 3 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, ***
1706 21 CFR 110.80(b)(10) 3 Mechanical manufacturing control Failure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, ***
1812 21 CFR 129.80(c) 3 Testing of cleaning/sanitizing solutions You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, ***
2301 21 CFR 129.80(f) 3 Bacteriological contamination of containers and closures (S) You do not take a bacteriological swab and/or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing. Specifically, ***
2427 21 CFR 110.80(b)(9) 3 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, ***
3074 21 CFR 114.80(a)(2) 3 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, ***
3650 21 CFR 110.35(d)(1) 3 Wet cleaning Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned. Specifically, ***
3709 21 CFR 110.80(a)(1) 3 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, ***
4295 21 CFR 110.40(a) 3 Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials. Specifically, ***
4465 21 CFR 114.100(c) 3 Process deviations - action to rectify Failure to record the action taken to rectify a departure from a scheduled process. Specifically, ***
4475 21 CFR 108.25(c)(3)(i) 3 Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
4476 21 CFR 108.25(c)(3)(ii) 3 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, ***
9952 21 CFR 120.11(a)(1)(i) 3 Complaint review Your review of consumer complaints does not determine whether such complaints [relate to the performance of the HACCP plan] [reveal previously unidentified critical control points]. Specifically, ***
12721 21 CFR 1.234 3 Registration not updated You did not submit an update to your facility's registration within 60 calendar days of [a change] [changes] to the registration information previously submitted. Specifically, ***
12733 21 CFR 120.11(a)(1)(iv)(C) 3 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, ***
12748 21 CFR 120.8(b)(5) 3 Corrective action plan 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,***
939 21 CFR 123.9(f) 2 Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. Specifically, ***
949 21 CFR 123.12(c) 2 Records, English The records that document the performance and results of the affirmative step you chose are not in English. Specifically, ***
1130 21 CFR 110.40(a) 2 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, ***
1188 21 CFR 110.37(c) 2 Sewage disposal Failure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, ***
1487 21 CFR 113.87(b) 2 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, ***
1500 21 CFR 113.89 2 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority. Specifically, ***
1529 21 CFR 113.89 2 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, ***
1559 21 CFR 110.35(c) 2 Guard/guide dogs The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
1595 21 CFR 110.37(b)(1) 2 Sufficient quantities of water Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required locations throughout the plant. Specifically, ***
1639 21 CFR 113.100(b) 2 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, ***
1665 21 CFR 110.80(a)(2) 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, ***
1716 21 CFR 113.40(a)(11) 2 Water valves, leakage Failure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing. Specifically, ***
2274 21 CFR 129.80(g)(1) 2 Bacteriological You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
2887 21 CFR 113.40(j) 2 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, ***
3068 21 CFR 114.80(a)(1) 2 pH control Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain] a pH value of 4.6 or lower in all finished foods. Specifically, ***
3708 21 CFR 110.80(a)(1) 2 Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, ***
4178 21 CFR 113.83 2 Commercial production variations Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process. Specifically, ***
4512 21 CFR 108.25(g) 2 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, ***
4523 21 CFR 108.35(f) 2 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, ***
4529 2 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, ***
4530 21 CFR 114.100(c) 2 Process deviations - product disposition Failure to record the disposition of product involved in a departure from a scheduled process. Specifically, ***
9921 21 CFR 120.10(b) 2 Corrective action - no plan Your HACCP plan does not include a corrective action plan. There was a deviation from a critical limit and you did not take corrective action that ensured [affected product was segregated and held] [a review of the affected product by someone who is adequately trained or experienced was done to determine its acceptability] [product that was injurious to health or otherwise adulterated was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was verified by someone meeting the training requirements of the regulation to determine if modifications were needed to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary]. Specifically, ***
9937 21 CFR 120.7(b) 2 Inside and outside hazards Your hazard analysis does not include food hazards that can be introduced [within] [outside] the processing plant environment. Specifically, ***
9950 21 CFR 120.11(a) 2 HACCP system not verified You do not verify that your HACCP system is being implemented according to design. Specifically, ***
9953 21 CFR 120.11(a)(1)(iv)(A) 2 CCP record review 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, ***
9959 21 CFR 120.12(d)(1) 2 Record retention You do not retain [all of] the required records at your facility for the required time period. Specifically, ***
9963 21 CFR 120.24(c) 2 Single facility - exempt process You do not process and perform final product packaging in a single facility operating under current good manufacturing practices. Specifically, ***
9972 21 CFR 120.25(c) 2 Analytical method You do not [always] analyze each juice subsample for the presence of Escherichia coli by the official method or another method that is at least equivalent. Specifically, ***
977 21 CFR 123.9(b)(3) 1 Records stored at another location You did not immediately return your records for official review upon demand. Specifically, ***
1045 21 CFR 113.10 1 Supervisors Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility. Specifically, ***
1093 21 CFR 110.40(g) 1 Compressed air/gases Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated with unlawful indirect food additives. Specifically, ***
1197 21 CFR 110.10(a) 1 Lack of instruction/reporting of health conditions Personnel with adverse health conditions are not instructed to report to their supervisors. Specifically, ***
1258 21 CFR 113.60(c) 1 Coding - visible Hermetically sealed containers do not have an identifying code permanently visible to the naked eye. Specifically ***
1277 21 CFR 129.20(d) 1 Enclosed room for container washing and sanitizing You do not [wash] [sanitize] containers for bottled drinking water in an enclosed room. Specifically, ***
1303 21 CFR 113.81(f) 1 Critical Factors The critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal process are not controlled in a manner to ensure the limits established are not exceeded. Specifically, ***
1317 21 CFR 113.87(d) 1 Timing devices Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved. Specifically, ***
1320 21 CFR 113.87(g) 1 Bleeder mufflers Failure to keep on file evidence that mufflers on [bleeders] [the vent system] are operating in a manner that does not impede the removal of air . Specifically, ***
1325 21 CFR 113.100(e) 1 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, ***
1329 21 CFR 113.100(a) 1 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, ***
1331 21 CFR 113.100(a)(1) 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, ***
1334 21 CFR 113.100(a)(4) 1 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, ***
1353 21 CFR 129.35(a)(3)(i) 1 Sampling for micro contaminants The [product] [operations] source water that is obtained from other than a public water system is not sampled and analyzed for microbiological contaminants at least once each week. Specifically, ***
1381 21 CFR 129.35(b) 1 Free of oil, dust, rust, etc. Air under pressure that is directed at [product water] [a product water-contact surface] is not free of [oil] [dust] [rust] [excessive moisture] [extraneous materials]. Specifically, ***
1412 21 CFR 129.37(b) 1 Transport and storage After cleaning, you do not [transport] [store] all [multiservice containers] [utensils] [disassembled piping and equipment] in such a manner as to [assure drainage] [be protected from contamination]. Specifically, ***
1472 21 CFR 113.83 1 Critical factors not stated Critical factors that may affect the scheduled process are not specified in the scheduled process. Specifically, ***
1486 21 CFR 113.87(b) 1 System not established A system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, ***
1499 21 CFR 113.89 1 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, ***
1533 21 CFR 113.100(b) 1 RTC identification Recording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed]. Specifically ***
1640 21 CFR 113.100(b) 1 Entries not signed The retort or processing system operator or other designated person did not initial or sign each record form. Specifically, ***
1644 21 CFR 113.100(c) 1 Not signed or initialed Written records of container closure examinations were not signed or initialed by the container closure inspector. Specifically, ***
1653 21 CFR 113.40(a)(1) 1 Unreadable MIG thermometer Mercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***
1688 21 CFR 110.80 1 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, ***
1708 21 CFR 110.80(b)(12) 1 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, ***
1710 21 CFR 110.80(b)(14) 1 Water activity controls Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms. Specifically, ***
1735 21 CFR 113.40(a)(2) 1 Unauthorized adjustment There was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
1855 21 CFR 113.40(a)(12) 1 Installation Vents are not installed so as to provide complete removal of air from a retort before the process start time. Specifically, ***
1863 21 CFR 113.40(a)(12) 1 Manifold header to atmosphere A manifold header connecting vents or manifolds from several retorts was not vented to the atmosphere. Specifically, ***
1945 21 CFR 129.80(d) 1 Records of sanitizing times and intensities (S) You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in contact with the surface being sanitized]. Specifically, ***
2056 21 CFR 123.28(a) 1 HACCP plan Your HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved source. Specifically, ***
2057 21 CFR 123.28(c) 1 Harvest licensure You do not have controls to ensure that the shellstock you receive [is from a harvester that is in compliance with licensure requirements or from a processor certified by a shellfish control authority] [has a tag affixed to each container or is accompanied by a bill of lading or similar document with specific information]. Specifically, ***
2059 21 CFR 123.28(d) 1 Labels - shucked shellfish You do not have controls in place to ensure that shucked molluscan shellfish are in containers that bear a label that discloses [the date and place they were harvested] [the type and quantity of shellfish] [by whom they were harvested]. Specifically, ***
2067 21 CFR 123.28(d) 1 Records - shucked shellfish You do not maintain records of shucked molluscan shellfish that document the [date of receipt] [quantity and type of shellfish] [name and certification number of the packer or repacker of the product]. Specifically, ***
2101 21 CFR 113.40(a)(13) 1 Measured, recorded Critical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
2271 21 CFR 129.80(e) 1 Package identification You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production code which identifies [the particular batch] [the segment of production run] [the day produced]. Specifically, ***
2272 21 CFR 129.80(e) 1 Plant records You do not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of finished product to wholesale and retail outlets]. Specifically, ***
2320 21 CFR 113.40(c)(2) 1 Corresponding with MIG Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***
2332 21 CFR 113.40(c)(5) 1 Location - separation Retort bleeders are installed more than eight (8) feet apart. Specifically, ***
2342 21 CFR 113.40(c)(6) 1 Heat distribution Heat distribution data or documentary proof from the retort manufacturer or process authority that adequate venting is achieved in the retort was not kept on file. Specifically, ***
2343 21 CFR 113.40(c)(7) 1 Rotational speed The rotational speed of the retort was not [specified in the scheduled process] [adjusted and recorded when the retort is started] [adjusted and recorded when a speed change was made] [adjusted and recorded at intervals of sufficient frequency to ensure the speed was maintained as specified in the scheduled process]. Specifically, ***
2369 21 CFR 129.80(a) 1 Equipment / substances You treat product water [in and by equipment] [with substances] that may adulterate the bottled product. Specifically, ***
2428 21 CFR 110.80(b)(9) 1 Proper reconditioning Failure to use a proven effective method of reconditioning adulterated food. Specifically, ***
2503 21 CFR 113.40(e)(2) 1 Unauthorized adjustment There was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***
2534 21 CFR 113.40(f)(2) 1 Presence and accuracy Each retort did not have an accurate temperature-recording device. Specifically, ***
2820 21 CFR 113.40(g)(1)(i)(d) 1 Product-to-product regenerators The product-to-product regenerator was not [designed] [operated] [controlled] to ensure that the pressure of the sterilized product in the regenerator is greater than that of the unsterilized product in the regenerator. Specifically, ***
2860 21 CFR 113.40(g)(1)(i)(f) 1 Unauthorized speed changes There was no means of preventing unauthorized speed changes to the metering pump. Specifically, ***
2869 21 CFR 113.40(g)(1)(ii)(e) 1 Readings at start of aseptic processing Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic processing to ensure the values were as specified in the scheduled process for aseptic packaging operations. Specifically, ***
2886 21 CFR 113.40(i) 1 Inadequate instruments The time and temperature of processing and other critical factors specified in the scheduled process were not measured with instruments having adequate accuracy or dependability. Specifically, ***
3072 21 CFR 114.80(a)(1) 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, ***
3091 21 CFR 114.100(e) 1 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, ***
3644 21 CFR 110.10(b)(5) 1 Impermeable (S) Gloves used for food handling are not impermeable. Specifically, ***
3648 21 CFR 110.20(a)(4) 1 Neighboring grounds Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control. Specifically, ***
3822 21 CFR 113.40(a)(1) 1 Records of calibration (S) Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test]. Specifically, ***
3833 21 CFR 113.40(g)(1)(i)(i) 1 Barriers to product contamination (S) Failure to supply steam seals or other effective barriers at potential access points to the product downstream from the product-sterilizing holding tube. Specifically, ***
3856 21 CFR 113.60(a) 1 Visual Failure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of a can randomly selected from each seaming head] [the closure of a typical container]. Specifically ***
3866 21 CFR 113.60(a)(1)(i)(a) 1 Required can seam measurements (micrometer) Records of the results of micrometer measurements of double seam cans fail to include [cover hook] [body hook] [width] [tightness] [thickness]. Specifically, ***
3874 21 CFR 113.60(b) 1 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, ***
3876 21 CFR 113.60(c) 1 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, ***
3877 21 CFR 113.60(c) 1 Coding - required elements The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed] [period during which packed]. Specifically, ***
3886 21 CFR 113.87(e) 1 Clock time agreement with time of day (S) Failure of the clock times indicated on recording-temperature charts to reasonably correspond to the time of day on the written processing records. Specifically, ***
3887 21 CFR 113.89 1 Methods of process deviation evaluation Failure to use procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health in the evaluation of a deviation from the scheduled process. Specifically, ***
4067 21 CFR 113.40(a)(12)(iii) 1 Venting, other installations Failure to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, for retort installations which deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)] [113.40(a)(12)(ii)(b)]. Specifically, ***
4460 21 CFR 114.80(a)(1) 1 Use of preservatives (S) Failure to use preservatives (in lieu of thermal processing) to inhibit reproduction of microorganisms of non-health significance. Specifically, ***
4519 21 CFR 108.35(c)(3)(i) 1 Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
4520 21 CFR 108.35(c)(3)(ii) 1 Process information availability Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, ***
4521 21 CFR 108.35(d) 1 Notify FDA - spoilage Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed. Specifically, ***
4524 21 CFR 108.35(g) 1 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, ***
6003 21 CFR 123.28(b) 1 Harvest controls You do not ensure that raw molluscan shellfish being processed are obtained from growing waters approved for harvesting by a shellfish control authority. Specifically***
6011 21 CFR 123.8(a)(3)(ii) 1 Corrective action record review adequacy Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken]. Specifically, ***
9812 21 CFR 106.100(k)(4) 1 Complaint files Failure to maintain complaint files [in two separate classes, e.g., complaints that allege that an infant became ill from consuming the product, or that an infant required treatment by a physician or health-care provider; and complaints that may involve a possible existence of a hazard to health, but do not indicate that an infant became ill or required treatment]. Specifically, ***
9914 21 CFR 120.14(c) 1 Records, English You do not have records [in English] that document the performance and results of the affirmative steps you chose. Specifically, ***
9923 21 CFR 120.10(b)(2) 1 Review - trained individual Your review to determine the acceptability of affected product for distribution when a deviation from a critical limit occurred was not performed by [an individual] [individuals] with adequate training or experience . Specifically, ***
9933 21 CFR 120.6(b) 1 Timely correction You do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, ***
9938 21 CFR 120.7(d) 1 Sanitation evaluation not complete (S) You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended consumer. Specifically, ***
9949 21 CFR 120.11(b) 1 HACCP plan not modified You did not immediately modify your HACCP plan after a validation revealed that the plan was no longer adequate. Specifically, ***
9975 21 CFR 120.25(d) 1 Recording You did not [always] record positive results for Escherichia coli analysis. Specifically, ***
9986 21 CFR 120.24(c) 1 Single facility - not exempt under 120.24(a) 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, ***
12736 21 CFR 120.12(e) 1 Official review You did not make all required records available for review and copying at reasonable times. Specifically, ***
12737 21 CFR 120.14(a)(2)(i) 1 Product specs Your product specifications are not designed to ensure that imported juice [is safe] [has been processed under sanitary conditions]. Specifically, ***
12753 21 CFR 120.11(a)(1)(iv)(A) 1 CA record review Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions were taken]. Specifically, ***

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Devices

Center Name Cite Id Ref No Frequency Short Description Long Description
Devices 4189 21 CFR 820.198(a) 153 General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented]. Specifically, ***
3130 21 CFR 820.100(a) 135 Procedures - general Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
3696 21 CFR 820.100(b) 100 Lack of documentation of CAPA activities Corrective and preventive action activities and/or results have not been [adequately] documented. Specifically, ***
630 21 CFR 803.17 100 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
546 21 CFR 820.75(a) 97 General A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, ***
4058 21 CFR 820.20 92 Management responsibility Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. Specifically, ***
2327 21 CFR 820.22 85 Quality audit procedures Procedures for quality audits have not been [adequately] established. Specifically, ***
2371 21 CFR 820.30(a) 80 Design control procedures Procedures for design control have not been established. Specifically,***
3666 21 CFR 820.20(c) 75 Management review procedures Procedures for management review have not been [adequately] established. Specifically,***
3415 21 CFR 820.22 70 Quality audits conducted Quality [audits][reaudits] have not been performed. Specifically, ***
447 21 CFR 820.40 64 Document control procedures Document control procedures have not been [established] [maintained]. Specifically,***
3291 21 CFR 820.100(b) 63 Procedures The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3172 21 CFR 820.198(c) 63 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, ***
3837 21 CFR 820.25(b) 61 Training documentation Personnel training is not documented. Specifically, ***
3233 21 CFR 820.72(a) 51 Calibration, inspection, equipment control procedures Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically, ***
3103 21 CFR 820.30(i) 51 Design changes - procedures prior to implementation Procedures for design change have not been [adequately] established. Specifically,***
3125 21 CFR 820.80(d) 49 Procedures, finished devices Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
3118 21 CFR 820.75(a) 47 Documentation - general Process validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved]. Specifically, ***
538 21 CFR 820.70(a) 47 Process control procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented]. Specifically, ***
3687 21 CFR 820.100(a)(1) 46 Analysis of data sources Appropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems. Specifically, ***
3371 21 CFR 820.198(a)(3) 45 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, ***
479 21 CFR 820.50 43 Purchasing control procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***
3282 21 CFR 820.90(a) 42 Nonconforming product control procedures Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***
3690 21 CFR 820.100(a)(3) 40 Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified. Specifically, ***
3155 21 CFR 820.181(a) 40 DMR device specifications The device master record does not include or refer to the location of device software specifications. Specifically, ***
3160 21 CFR 820.184 39 Establishing device history record procedures Procedures for device history records have not been [adequately] established. Specifically,***
2302 21 CFR 820.20(e) 38 Quality System Procedures Quality system procedures and instructions have not been established. Specifically,***
486 21 CFR 820.50(a) 38 Evaluation of suppliers, contractors and consultants Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, ***
2974 21 CFR 812.110(b) 37 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, ***
2968 21 CFR 812.100 37 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, ***
732 21 CFR 803.50(a)(2) 37 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, ***
3669 21 CFR 820.20(c) 36 Management reviews at defined intervals Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
3299 21 CFR 820.100(a)(1) 35 Procedure for analysis of data sources The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3167 21 CFR 820.198(a) 33 Complete files maintained Complete complaint files are not maintained. Specifically, ***
3692 21 CFR 820.100(a)(4) 32 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, ***
3678 21 CFR 820.30(g) 31 Risk analysis Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
3369 21 CFR 820.198(a)(1) 30 Uniform and timely processing Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are processed in a uniform and timely manner. Specifically, ***
3120 21 CFR 820.80(a) 30 General Procedures for acceptance activities have not been [adequately] established. Specifically,***
541 21 CFR 820.70(c) 30 Environmental control Procedures to control environmental conditions have not been [adequately] established. Specifically, ***
3665 21 CFR 820.20(b)(3) 29 Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system. Specifically, ***
3121 21 CFR 820.80(b) 29 Receiving acceptance procedures Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
2351 21 CFR 820.25(b) 29 Training Employees have not been adequately trained. Specifically, ***
2350 21 CFR 820.25(b) 29 Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***
731 21 CFR 803.50(a)(1) 29 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, ***
14505 21 CFR 812.140(a)(3) 28 Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current]. Specifically, ***
4059 21 CFR 820.22 28 Quality audits - effectiveness of quality system 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, ***
3127 21 CFR 820.80(e) 27 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, ***
3288 21 CFR 820.90(b)(1) 26 Documentation of disposition, justification, signature There is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the signature of the individual authorizing the use of nonconforming product]. Specifically, ***
3164 21 CFR 820.184(d) 26 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, ***
3283 21 CFR 820.90(a) 25 Specific non-conforming product procedures Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete]. Specifically, ***
3117 21 CFR 820.70(i) 24 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, ***
3433 21 CFR 820.75(c) 23 Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
3284 21 CFR 820.90(a) 23 Nonconforming product evaluation/investigation The [evaluation] [investigation] of nonconforming product has not been documented. Specifically, ***
3201 21 CFR 820.40(a) 23 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, ***
3199 21 CFR 820.40(a) 23 Document review, approval documentation The documentation of approval of documents does not include [the document approval date] [the signature of the approving official]. Specifically, ***
2293 21 CFR 820.20(d) 23 Quality plan A quality plan has not been [adequately] established. Specifically, ***
3688 21 CFR 820.100(a)(1) 22 Analysis of data/reports from data sources Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems. Specifically, ***
3301 21 CFR 820.100(a)(2) 22 Investigation procedures The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3416 21 CFR 820.70(a)(1) 21 Process control instructions Process controls are not conducted in accordance with documented instructions and standard operating procedures. Specifically, ***
3332 21 CFR 820.184(e) 21 ID label, labeling The device history record does not include the primary identification label and labeling for each device. Specifically, ***
3159 21 CFR 820.184 21 DHR content - general The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
3104 21 CFR 820.30(j) 21 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].
537 21 CFR 820.70(a) 21 Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications. Specifically, ***
3101 21 CFR 820.30(g) 20 Design validation procedures Procedures for design validation have not been [adequately] established. Specifically,***
2328 21 CFR 820.22 20 Quality audits, auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
4191 21 CFR 806.10(a)(1) 19 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, ***
3689 21 CFR 820.100(a)(2) 19 Investigation Certain indicators of nonconformities are not investigated to determine the cause of the nonconformity. Specifically, ***
3380 21 CFR 820.198(e)(6) 19 Results of investigation Records of complaint investigations do not include the [dates] [results] of the investigation. Specifically, ***
3250 21 CFR 820.72(b)(2) 19 Calibration documentation There is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the next calibration date] for [inspection] [measurement] [test] equipment . Specifically, ***
3119 21 CFR 820.75(b) 19 Monitoring and control of validated processes Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, ***
3268 21 CFR 820.80(b) 18 Incoming inspection, testing, verification Incoming product was not adequately inspected or tested to verify conformance to specifications. Specifically, ***
3128 21 CFR 820.90(a) 18 Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, ***
2628 21 CFR 820.30(e) 18 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, ***
2269 21 CFR 820.20(a) 18 Quality policy established The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically, ***
4070 21 CFR 820.30(g) 17 Design validation documentation, DHF {see also 820.30(j)} 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, ***
3677 21 CFR 820.30(g) 17 Design validation of device software Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
3304 21 CFR 820.100(a)(5) 17 Changes to correct/prevent quality problems Changes in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective]. Specifically, ***
3102 21 CFR 820.30(h) 17 Design transfer Procedures for design transfer have not been [adequately] established. Specifically,***
3226 21 CFR 820.70(g)(1) 16 Schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, ***
2981 21 CFR 812.140(a)(2)(i) 16 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, ***
2650 21 CFR 820.30(f) 16 Design verification Procedures for design verification have not been [adequately] established. Specifically,***
2648 21 CFR 820.30(f) 16 Design verification procedures Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
2429 21 CFR 820.30(b) 16 Establish the design and development plan A design and development plan has not been [established] [defined] [documented] [implemented]. Specifically, ***
3303 21 CFR 820.100(a)(4) 15 Verify, validate change {see also 820.100(a)} The procedures addressing verification or validation of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3285 21 CFR 820.90(b)(2) 15 Product rework procedures Procedures for rework of nonconforming product have not been [adequately] established. Specifically, ***
3157 21 CFR 820.181(c) 15 DMR QA procedures and specifications The device master record does not include or refer to the location of [all] quality assurance procedures and specifications. Specifically, ***
3132 21 CFR 820.120 15 Labeling procedures - general Procedures to control labeling activities have not been [adequately] established. Specifically, ***
3680 21 CFR 820.70(a) 14 Process control procedure content Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established. Specifically, ***
3427 21 CFR 820.50(a)(2) 14 Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
3345 21 CFR 820.200(a) 14 Procedures established Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
3286 21 CFR 820.90(b)(1) 14 Procedures for product review, disposition Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established. Specifically, ***
3156 21 CFR 820.181(b) 14 DMR production process specifications The device master record does not include or refer to the location of [all] production and process specifications. Specifically, ***
2984 21 CFR 812.140(a)(3)(i) 14 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, ***
4212 21 CFR 806.20(b)(4) 13 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,***
3302 21 CFR 820.100(a)(3) 13 Identifying corrective & preventive actions The procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3231 21 CFR 820.70(i) 13 Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented. Specifically, ***
3123 21 CFR 820.80(c) 13 Procedures Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
539 21 CFR 820.70(b) 13 Production and process change procedures Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, ***
3681 21 CFR 820.70(b) 12 Verification or validation of changes Changes to a [specification] [method] [process] [procedure] were not verified or validated. Specifically, ***
3417 21 CFR 820.70(a)(2) 12 Production monitoring and control During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled. Specifically, ***
3276 21 CFR 820.80(e) 12 Maintained as part of the DHR {see also 820.184} Acceptance records were not maintained as part of the device history record. Specifically, ***
3270 21 CFR 820.80(c) 12 Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3151 21 CFR 820.180 12 Legibility Required records are not legible. Specifically, ***
3021 21 CFR 812.150(a)(1) 12 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, ***
2604 21 CFR 820.30(e) 12 Design review procedures - general Procedures for design review have not been [adequately] established. Specifically,***
540 21 CFR 820.70(b) 12 Production and process changes - failure to follow procedure Established procedures were not followed [completely] in making changes to [specifications] [methods] [processes] [procedures]. Specifically, ***
3686 21 CFR 820.90(b)(2) 11 Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, ***
3683 21 CFR 820.70(g) 11 Installation, placement qualification 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, ***
3426 21 CFR 820.50(a)(1) 11 Documenting evaluation The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
3269 21 CFR 820.80(b) 11 Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented. Specifically, ***
3170 21 CFR 820.198(b) 11 Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
3108 21 CFR 820.70(e) 11 Contamination control 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, ***
2557 21 CFR 820.30(c) 11 Design input documentation Design input requirements were not [adequately] documented. Specifically, ***
3702 21 CFR 820.250(a) 10 Appropriateness There is no information to support the appropriateness of the statistical techniques used. Specifically, ***
3676 21 CFR 820.30(f) 10 Design verification documentation, DHF {see also 820.30(j)} 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, ***
3428 21 CFR 820.50(a)(3) 10 Acceptable supplier records Records of acceptable [suppliers] [contractors] [consultants] were not maintained. Specifically, ***
3262 21 CFR 820.250(a) 10 Establish procedures for identifying statistical techniques 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,***
3207 21 CFR 820.50(b) 10 Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, ***
3206 21 CFR 820.50(b) 10 Purchasing records, specification 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, ***
3204 21 CFR 820.40(b) 10 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, ***
3192 21 CFR 820.30(g) 10 Design validation per user needs and intended use Design validation did not ensure the device conforms to defined user needs and intended uses. Specifically, ***
3141 21 CFR 820.150(a) 10 Storage procedures to prevent mix-ups Procedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete] [implemented] to prevent mix-ups, damage, other adverse effects. Specifically, ***
2985 21 CFR 812.140(a)(3)(ii) 10 Investigator records of relevant observations inadequate Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the investigation] [all diagnostic test results] are not all [accurate] [complete] [current]. Specifically, ***
2970 21 CFR 812.100 10 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
2601 21 CFR 820.30(d) 10 Essential design outputs Design outputs that are essential for the proper functioning of the device were not [completely] identified. Specifically, ***
3664 21 CFR 820.20(b)(2) 9 Training Personnel are not adequately trained to perform [management activities] [work] [assessment activities] [audits]. Specifically, ***
3398 21 CFR 820.80(d)(3) 9 No release signature Finished devices were released for distribution without signature of the individual designated to authorize such release. Specifically, ***
3379 21 CFR 820.198(e)(5) 9 Nature and details of complaint Records of complaint investigations do not include the nature and details of the complaint. Specifically, ***
3263 21 CFR 820.250(b) 9 Establishment, appropriateness Sampling plans are not [written][based on valid statistical rationale]. Specifically, ***
3232 21 CFR 820.72(a) 9 Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically, ***
3173 21 CFR 820.198(d) 9 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, ***
3171 21 CFR 820.198(b) 9 Rationale documented for no investigation Records for complaints where no investigation was made do not include required information. Specifically ***
3144 21 CFR 820.160(a) 9 Control/distribution procedures Procedures for the control and distribution of finished devices have not been [established] [defined] [documented] [complete] [implemented] to ensure that only devices approved for release are distributed. Specifically, ***
3025 21 CFR 812.150(a)(3) 9 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, ***
2980 21 CFR 812.140(a)(1) 9 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, ***
2630 21 CFR 820.30(e) 9 Design review documentation, DHF {see also 820.30(j)} The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file. Specifically, ***
2599 21 CFR 820.30(d) 9 Acceptance criteria and essential outputs Design output procedures do not [contain or reference acceptance criteria] [ensure that essential design outputs are identified] [allow for an adequate evaluation of conformance to design input requirements]. Specifically, ***
2470 21 CFR 820.30(c) 9 Design input procedures - appropriateness Procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
631 21 CFR 803.17(a)(1) 9 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, ***
502 21 CFR 820.60 9 Identification Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established. Specifically, ***
454 21 CFR 820.40(a) 9 Document review, approval by designated individual Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance . Specifically, ***
14508 21 CFR 812.140(a)(4) 8 Investigator record of protocol deviations inadequate Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,***
4208 21 CFR 806.20(a) 8 Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,***
4193 21 CFR 806.10(b) 8 Time to report - 10 days A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal. Specifically, ***
3670 21 CFR 820.20(c) 8 Management review participants Documentation does not show that management with executive responsibility participated in management reviews. Specifically, ***
3397 21 CFR 820.80(d)(2) 8 Review of data and documentation Finished devices were released for distribution before the associated data and documentation was reviewed. Specifically, ***
3381 21 CFR 820.198(e)(7) 8 Corrective action taken Records of complaint investigations do not include any corrective action taken. Specifically, ***
3266 21 CFR 820.86 8 Clearly identified The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained]. Specifically, ***
3227 21 CFR 820.70(g)(1) 8 Activity documentation Maintenance activities, including the [date] [individuals performing those activities], have not been documented. Specifically, ***
3191 21 CFR 820.30(g) 8 Design validation production units The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, ***
2928 21 CFR 812.40 8 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, ***
2649 21 CFR 820.30(f) 8 Design verification acceptance criteria Acceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities. Specifically, ***
4192 21 CFR 806.10(a)(2) 7 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, ***
3693 21 CFR 820.100(a)(5) 7 Implementing changes Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3370 21 CFR 820.198(a)(2) 7 Oral complaints Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all oral complaints are documented upon receipt. Specifically, ***
3306 21 CFR 820.100(a)(7) 7 Management review The procedures addressing submission of information on identified quality problems and corrective and preventive actions for management review were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3300 21 CFR 820.100(a)(1) 7 Statistical methodology Corrective and preventive action procedures addressing the use of appropriate statistical methodology to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
3190 21 CFR 820.30(g) 7 Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities. Specifically, ***
3149 21 CFR 820.180 7 Availability Required records [are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA] [were not made readily available for review and copying by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed up when stored in automated data processing systems]. Specifically, ***
2556 21 CFR 820.30(c) 7 Incomplete, ambiguous, conflicting design requirements Design input requirements that are [incomplete] [ambiguous] [conflicting] were not addressed. Specifically, ***
2430 21 CFR 820.30(b) 7 Adequacy of design and development plan Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established. Specifically, ***
6847 21 CFR 807.30(b) 6 Listing not updated or update not timely Device listing information was not updated [in a timely manner]. Specifically, ***
4169 21 CFR 820.100(a)(7) 6 Identifying relevant info for management review Procedures addressing identification of relevant information to be submitted for management review were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
4168 21 CFR 820.100(a)(7) 6 Management review of CAPA Information on identified quality problems and corrective actions has not been [submitted for review by] [reviewed by] management. Specifically, ***
4060 21 CFR 820.20(b)(3)(i) 6 Management representative implementing the quality system The management representative has not ensured that the quality system requirements are effectively established and maintained. Specifically, ***
3675 21 CFR 820.30(f) 6 Design verification - unresolved discrepancies Unresolved discrepancies were noted at the completion of the design verification. Specifically, ***
3667 21 CFR 820.20(c) 6 Management review accomplishment Management reviews do not ensure that the quality system satisfies [the requirements of part 820] [your quality policy and objectives]. Specifically, ***
3396 21 CFR 820.80(d)(1) 6 DMR required activities {see also 820.181} Finished devices were released for distribution prior to completion of activities required in the Device Master Record. Specifically, ***
3382 21 CFR 820.198(e)(8) 6 Reply to complainant Records of complaint investigations do not include any reply to the complainant. Specifically, ***
3330 21 CFR 820.181(d) 6 DMR packaging and labeling specifications The device master record does not include or refer to the location of [packaging] [labeling] procedures and specifications. Specifically, ***
3316 21 CFR 820.160(a) 6 Expired or deteriorated devices Procedures have not been [established] [defined] [documented] [complete] [implemented] to ensure that expired or deteriorated devices are not distributed. Specifically, ***
3235 21 CFR 820.72(a) 6 Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, ***
3203 21 CFR 820.40(b) 6 Change records maintained Records of changes to documents were not [adequately] maintained. Specifically, ***
3195 21 CFR 820.30(g) 6 Design validation unresolved discrepancies Unresolved discrepancies were noted at the completion of the design validation. Specifically, ***
3139 21 CFR 820.140 6 Handling procedures to prevent mix-ups Procedures for product handling have not been [adequately] established. Specifically,***
3111 21 CFR 820.70(f) 6 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, ***
2598 21 CFR 820.30(d) 6 Design output procedures Procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
2339 21 CFR 820.22 6 Quality audit documentation The dates of quality [audits][reaudits] have not been documented. Specifically, ***
733 21 CFR 803.50(b)(1) 6 Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, ***
14507 21 CFR 812.140(a)(3)(ii) 5 Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current]. Specifically, ***
6800 21 CFR 807.20 5 Establishment not registered An establishment for which registration is required has not been registered. Specifically, ***
3694 21 CFR 820.100(a)(6) 5 Dissemination of problem information Information related to quality problems or nonconforming product is not disseminated to those directly responsible for assuring the [quality of the product] [prevention of the quality problem]. Specifically, ***
3673 21 CFR 820.30(c) 5 Design input approval documentation The approval of design input requirements [(including the date and signature of the individual approving the requirements)] was not documented. Specifically, ***
3668 21 CFR 820.20(c) 5 Management review dates The results and/or dates of management reviews are not documented. Specifically, ***
3434 21 CFR 820.75(c) 5 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, ***
3425 21 CFR 820.50(a)(1) 5 Evaluation and selection Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, ***
3313 21 CFR 820.120(d) 5 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, ***
3312 21 CFR 820.120(d) 5 Mix-ups Labeling and packaging operations were not controlled to prevent labeling mix-ups. Specifically, ***
3193 21 CFR 820.30(g) 5 Design validation - production units in use conditions The design was not validated under actual or simulated use conditions. Specifically, ***
3161 21 CFR 820.184(a) 5 DHR content - manufacturing dates The device history record does not include manufacturing dates. Specifically, ***
3049 21 CFR 812.150(b)(5) 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, ***
2973 21 CFR 812.110(a) 5 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, ***
2627 21 CFR 820.30(e) 5 Design reviews performed following schedule Design reviews were not performed at appropriate times, following the review schedule. Specifically, ***
542 21 CFR 820.70(c) 5 Environmental control system periodic inspections Environmental control systems have not been inspected periodically to verify that the system, including necessary equipment, is adequate and functioning properly. Specifically, ***
419 21 CFR 820.20(b) 5 Establish 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, ***
6803 21 CFR 807.20(a) 4 Devices not listed Devices for which listing is required have not been listed. Specifically, ***
4071 21 CFR 820.30(i) 4 Design changes - validation vs. verification Procedures were not [established] [defined] [documented] [completed] to address when verification of design changes is sufficient in lieu of validation prior to their implementation. Specifically, ***
4057 21 CFR 820.20(a) 4 Management responsibility Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. Specifically, ***
3838 21 CFR 820.40(a) 4 Document review procedures, designated individual The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, ***
3682 21 CFR 820.70(d) 4 Implementing Personnel Procedures, Health, Cleanliness. Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, ***
3671 21 CFR 820.25(a) 4 Personnel education, background, training & experience Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
3399 21 CFR 820.80(d)(4) 4 No release authorization date Finished devices were released for distribution without the authorization being dated. Specifically, ***
3349 21 CFR 820.200(d) 4 No documentation Service reports were not documented. Specifically, ***
3328 21 CFR 820.180(b) 4 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, ***
3325 21 CFR 820.180 4 Storage Required records [are not stored so as to minimize deterioration and prevent loss] [that are stored in automated data processing systems are not backed up]. Specifically, ***
3007 21 CFR 812.140(d) 4 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, ***
2969 21 CFR 812.100 4 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected. Specifically, ***
2431 21 CFR 820.30(b) 4 Design plans updated Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, ***
2330 21 CFR 820.22 4 Quality audit corrective action, reaudits {see also 820.100} Quality reaudits [are not adequately performed] [do not cover corrective actions for the problem areas]. Specifically, ***
812 21 CFR 803.56 4 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, ***
632 21 CFR 803.17(a)(2) 4 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, ***
14516 21 CFR 812.25(e) 3 Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study. Specifically,***
7012 21 CFR 812.100 3 Investigator lack of control of investigational devices Devices under investigation were not properly controlled. Specifically, ***
7006 21 CFR 812.43(c)(5) 3 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, ***
3841 21 CFR 820.90(b)(2) 3 Product rework adverse effects {see also 820.184} Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from rework upon the product. Specifically, ***
3432 21 CFR 820.75(b)(2) 3 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, ***
3414 21 CFR 820.200(d)(6) 3 Test and inspection data Service reports do not include applicable test and/or inspection data. Specifically, ***
3376 21 CFR 820.198(e)(2) 3 Date complaint received Records of complaint investigations do not include the date the complaint was received. Specifically, ***
3347 21 CFR 820.200(c) 3 Complaints, MDR reports {see also 820.198(a)(3)} Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
3310 21 CFR 820.120(b) 3 DHR documentation of label release {see also 820.184} The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner. Specifically, ***
3290 21 CFR 820.90(b)(2) 3 Retesting and reevaluation of reworked product Rework of nonconforming product did not include [complete] retesting and reevaluation to ensure that the reworked product met current approved specifications. Specifically, ***
3218 21 CFR 820.70(c) 3 Environmental control system-documentation/review inspection Inspections of environmental control system were not [documented] [reviewed]. Specifically, ***
3200 21 CFR 820.40(a) 3 Document locations, dissemination Documents were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, ***
3168 21 CFR 820.198(a) 3 Designated unit Complaint files are not [adequately] maintained. Specifically ***
3163 21 CFR 820.184(c) 3 Quantity released The device history record does not include the quantity of devices released for distribution. Specifically, ***
3162 21 CFR 820.184(b) 3 Quantity manufactured The device history record does not include the quantity of devices manufactured. Specifically, ***
3028 21 CFR 812.150(a)(4) 3 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, ***
2992 21 CFR 812.140(b)(2) 3 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, ***
2930 21 CFR 812.42 3 Sponsor began study before IRB/FDA approval [An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***
2602 21 CFR 820.30(d) 3 Design output approval Design output was not [reviewed] [approved] before release. Specifically, ***
2481 21 CFR 820.30(c) 3 Design input procedures - addressing conflicting requirement Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***
2403 21 CFR 820.25(a) 3 Sufficient personnel Insufficient personnel to assure that all procedures are appropriately carried out as required by the quality system. Specifically, ***
2338 21 CFR 820.22 3 Quality audit/reaudit reports Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically, ***
2276 21 CFR 820.20(b)(1) 3 Responsibility, authority and independence Employees who manage, perform, and assess work affecting quality have not been [assigned the appropriate responsibility and authority] [provided the independence and authority] to accomplish their work. Specifically, ****
635 21 CFR 803.17(b)(1) 3 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, ***
633 21 CFR 803.17(a)(3) 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, ***
14509 21 CFR 812.150(b)(1) 2 Sponsor evaluation report incomplete, inaccurate Reports of the results of evaluation of unanticipated adverse device effects were not all [complete] [accurate]. Specifically, ***
7013 21 CFR 812.110(d) 2 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, ***
4213 21 CFR 806.20(b)(5) 2 Records of communications A copy of all communications regarding the correction or removal action was not contained in the record. Specifically,***
3701 21 CFR 820.250(a) 2 Techniques not used Statistical techniques are not used for control purposes where statistical techniques are applicable. Specifically, ***
3674 21 CFR 820.30(d) 2 Design output documentation Design output was not [adequately] documented before release. Specifically, ***
3420 21 CFR 820.70(a)(5) 2 Criteria for workmanship Criteria for workmanship have not been expressed in documented standards or by means of identified and approved representative samples. Specifically, ***
3400 21 CFR 820.80(e)(1) 2 Activities performed Acceptance records did not include the acceptance activities performed. Specifically, ***
3378 21 CFR 820.198(e)(4) 2 Complainant data Records of complaint investigations do not include the [name] [address] [phone number] of the complainant. Specifically, ***
3377 21 CFR 820.198(e)(3) 2 Device identification and control number Records of complaint investigations do not include device identifications and control numbers used. Specifically, ***
3375 21 CFR 820.198(e)(1) 2 Device name Records of complaint investigations do not include required information. Specifically, ***
3374 21 CFR 820.198(d)(3) 2 Determination of relationship of device to event Investigation of MDR reportable complaints did not include a determination of the relationship of the device to the reported incident or adverse event. Specifically, ***
3372 21 CFR 820.198(d)(1) 2 Determination of whether device met specifications Investigation records of MDR reportable complaints do not include required information. Specifically ***
3333 21 CFR 820.184(f) 2 Device identification, control numbers The device history record does not include [certain] [any] device identifications and control numbers used. Specifically, ***
3309 21 CFR 820.120(b) 2 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, ***
3241 21 CFR 820.72(b)(1) 2 Calibration standard traceability A calibration standard used for [inspection] [measurement] [test] equipment is not traceable to national or international standards nor is it an independent reproducible standard. Specifically, ***
3239 21 CFR 820.72(b) 2 Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3236 21 CFR 820.72(b) 2 Procedures - content Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, ***
3224 21 CFR 820.70(g)(2) 2 Periodic equipment inspection Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established. Specifically, ***
3216 21 CFR 820.70(b) 2 Changes documented Changes were not [documented] [followed]. Specifically, ***
3198 21 CFR 820.40(b) 2 Changes - review and approval 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, ***
3147 21 CFR 820.170(a) 2 Installation instructions, test procedures [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established. Specifically,***
3142 21 CFR 820.150(a) 2 Storage procedures to avoid release of unsuitable product Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed. Specifically, ***
3113 21 CFR 820.70(g) 2 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, ***
3038 21 CFR 812.150(b)(1) 2 Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within 10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating investigators]. Specifically, ***
3034 21 CFR 812.150(a)(6) 2 Investigator final report A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation. Specifically, ***
3032 21 CFR 812.150(a)(5) 2 Investigator report for lack of informed consent A report to the [sponsor] [reviewing IRB] regarding the use of an investigational device without obtaining informed consent was not submitted [within five working days after the use occurred]. Specifically, ***
3027 21 CFR 812.150(a)(4) 2 Investigator non-emergency safety or soundness changes In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] . Specifically, ***
3003 21 CFR 812.140(b)(6) 2 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, ***
2993 21 CFR 812.140(b)(2) 2 Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current]. Specifically, ***
2991 21 CFR 812.140(b)(1) 2 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, ***
2975 21 CFR 812.110(c) 2 Investigator did not supervise use of investigational device An investigational device was used for subjects not under the supervision of an authorized investigator. Specifically, ***
2972 21 CFR 812.110(a) 2 Informed consent obtained prior to study approval Written informed consent of potential subjects to participate in an investigation was obtained prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
2935 21 CFR 812.43(b) 2 Sponsor shipped devices to unqualified person(s) Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation. Specifically, ***
2600 21 CFR 820.30(d) 2 Acceptance criteria not identified Acceptance criteria for design outputs were not identified. Specifically, ***
2279 21 CFR 820.20(b)(2) 2 Resources Adequate resources have not been provided for performing [management activities] [work] [assessment activities] [audits]. Specifically, ***
2270 21 CFR 820.20(a) 2 Implement quality policy Not all employees [know there is] [understand] [fully implement] the quality policy. Specifically, ***
796 21 CFR 803.55(a) 2 Initial Submission of Baseline Report A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model. Specifically, ***
750 21 CFR 803.52(b)(4) 2 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, ***
749 21 CFR 803.52(b)(3) 2 Date of Event An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event. Specifically, ***
735 21 CFR 803.50(b)(2) 2 Explanation of Incomplete Information An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information. Specifically, ***
14517 21 CFR 812.35(a)(1) 1 No approval for changes requiring prior approval [FDA] [IRB] approval was not obtained for changes to an investigational plan that require prior approval. Specifically, ***
9176 21 CFR 809.20(b) 1 Compliance with GMP In vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System Regulation. Specifically, ***
6849 21 CFR 812.5(a) 1 Label does not contain required information The label for an investigational device does not include [the name and place of business of manufacturer, packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use."]. Specifically, ***
6805 21 CFR 807.25(b) 1 Device activities not reported Device activities have not been reported to FDA. Specifically, ***
6804 21 CFR 807.21(b) 1 Listing not updated Existing device information changed, but the listing was not updated during [June] [December] (or earlier) as required. Specifically, ***
6802 21 CFR 807.21(a) 1 Annual registration Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA]. Specifically, ***
4436 21 CFR 803.40(a) 1 Report of death, injury by marketed device The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving information that one of its marketed devices may have caused or contributed to a [death] [serious injury]. Specifically, ***
4432 21 CFR 803.18(d)(3) 1 Distributor complaint files locations The device distributor does not maintain the device complaint files at the distributor's principal business establishment. Specifically, ***
4207 21 CFR 806.10(d) 1 Notification of extended action No amended notification with required information was submitted within 10 working days of initiating an extension of the correction or removal action. Specifically,***
4200 21 CFR 806.10(c)(7) 1 Event description The events that led to reporting and/or conducting the correction or removal actions were not described. Specifically,***
4167 21 CFR 820.70(g) 1 Specified requirements Equipment used in the manufacturing process does not meet specified requirements. Specifically, ***
4061 21 CFR 820.20(b)(3)(ii) 1 Management representative's reports The management representative has not [fully] reported on the quality system performance to management with executive responsibility. Specifically, ***
3840 21 CFR 820.72(b)(1) 1 In-house calibration standards In the absence of a national or international standard, or an independent reproducible standard, no in-house standard has been established for [inspection] [measuring] [test] equipment. Specifically, ***
3839 21 CFR 820.70(a)(4) 1 Approval of process equipment Process equipment has not been approved. Specifically, ***
3706 21 CFR 820.250(b) 1 Review of sampling methods for adequacy The review of sampling methods for adequacy for their intended use was not documented. Specifically, ***
3698 21 CFR 820.150(b) 1 Procedures - receipt and dispatch Procedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, ***
3697 21 CFR 820.150(a) 1 Stock rotation, assessment before release Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate. Specifically, ***
3691 21 CFR 820.100(a)(4) 1 Verification vs validation There is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation. Specifically, ***
3672 21 CFR 820.30(c) 1 Design input review and approval Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
3429 21 CFR 820.75(b)(1) 1 Performed by qualified individual A validated process was not performed by a qualified individual. Specifically, ***
3419 21 CFR 820.70(a)(4) 1 Approval of process Processes have not been approved. Specifically, ***
3418 21 CFR 820.70(a)(3) 1 Standards or codes Process controls do not include testing devices for compliance with applicable standards or codes, as required by device specifications. Specifically, ***
3404 21 CFR 820.80(e)(5) 1 Equipment Acceptance records did not identify the equipment used in the tests. Specifically, ***
3403 21 CFR 820.80(e)(4) 1 Signature Acceptance records did not include the signature of the individual performing the acceptance activities. Specifically, ***
3385 21 CFR 820.25(b)(1) 1 Training on defects Employees have not been made aware of device defects that could occur when they improperly perform their jobs. Specifically, ***
3373 21 CFR 820.198(d)(2) 1 Determination of use for treatment or diagnosis Investigation of MDR reportable complaints did not include a determination of whether the device was being used for treatment or diagnosis. Specifically, ***
3355 21 CFR 820.198(f) 1 Records accessible to manufacturing site Investigated complaints and records of investigation were not accessible to the manufacturing establishment. Specifically, ***
3346 21 CFR 820.200(b) 1 Statistical analysis {see also 820.100(a)(1)} Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3343 21 CFR 820.198(e) 1 Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3331 21 CFR 820.181(e) 1 DMR installation/maintenance/servicing procedures A device master record has not been [adequately] maintained. Specifically, ***
3324 21 CFR 820.170(b) 1 Installer's documentation of results The person installing the device did not document complete inspection and test results to demonstrate proper installation. Specifically, ***
3311 21 CFR 820.120(c) 1 Storage Labels were stored such that mix-ups were possible. Specifically, ***
3267 21 CFR 820.86 1 Maintained The acceptance status of product was not clearly identified throughout [manufacturing] [packaging] [labeling] [installation] [servicing] of the product. Specifically, ***
3237 21 CFR 820.72(b) 1 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, ***
3230 21 CFR 820.70(i) 1 Validation of changes to automated process software Changes to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance. Specifically, ***
3210 21 CFR 820.65 1 Documentation of control numbers {see also 820.184} Control numbers for [implantable or life supporting devices] [appropriate components] were not documented in the device history record. Specifically, ***
3202 21 CFR 820.40(b) 1 Changes, communication Approved changes were not communicated to appropriate personnel in a timely manner. Specifically, ***
3175 21 CFR 820.186 1 QSR content The quality system record has not been [adequately] maintained Specifically ***
3138 21 CFR 820.130 1 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, ***
3065 21 CFR 812.140(a)(5) 1 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, ***
3064 21 CFR 812.140(a)(4) 1 Investigator protocol records inadequate Copies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***
3057 21 CFR 812.150(b)(8) 1 Sponsor report of use without informed consent A copy of a report from an investigator regarding use of an investigational device without obtaining informed consent was not submitted to FDA [within five working days of receipt]. Specifically, ***
3054 21 CFR 812.150(b)(7) 1 30-day sponsor notification to FDA FDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk device study. Specifically, ***
3052 21 CFR 812.150(b)(6) 1 Sponsor notif. of rqst. to return/repair/dispose not made Notification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device. Specifically, ***
3046 21 CFR 812.150(b)(4) 1 No 6-month sponsor reports of current investigators Current lists of the names and addresses of all investigators participating in an investigation were not [always] submitted to FDA at six month intervals after FDA approval of the investigation. Specifically, ***
3002 21 CFR 812.140(b)(5) 1 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, ***
2994 21 CFR 812.140(b)(3) 1 Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
2983 21 CFR 812.140(a)(2)(iii) 1 Investigator records of disposition of devices inadequate Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
2942 21 CFR 812.43(c)(4)(iii) 1 No informed consent statement in investigator agreement A signed agreement that includes a statement of the investigator's commitment to ensure that the requirements for obtaining informed consent are met was not obtained from each participating investigator. Specifically, ***
2939 21 CFR 812.43(c)(3) 1 No research termination info in investigator agreement A signed agreement, that includes an explanation of the circumstances that led to the termination of any investigations in which the investigator was involved, was not obtained from each participating investigator. Specifically, ***
2938 21 CFR 812.43(c)(2) 1 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, ***
2937 21 CFR 812.43(c)(1) 1 No curriculum vitae in investigator agreement The signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae. Specifically, ***
2924 21 CFR 812.20(a)(2) 1 Initiation of study prior to FDA IDE approval FDA approval was not obtained prior to initiation of an investigation for which an FDA-approved IDE was required. Specifically, ***
2923 21 CFR 812.20(a)(1) 1 Did not submit IDE application to FDA An application was not submitted to FDA when [a significant risk device investigation was to be undertaken] [an investigation that involves exception from informed consent was intended] [FDA sent notification that an application was required for an investigation]. Specifically, ***
2916 21 CFR 812.7(d) 1 Investigational device represented as safe and /or effective An investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically, ***
2910 21 CFR 812.7(a) 1 Promotion or test marketing An investigational device was [promoted] [test marketed] prior to FDA approval/clearance. Specifically, ***
809 21 CFR 803.55(b)(9) 1 Quantity Manufactured and Distributed A baseline report submitted on FDA Form 3417 did not contain [the number of devices manufactured and distributed in the last 12 months] [an estimate of the number of devices in current use]. Specifically, ***
797 21 CFR 803.55(b) 1 Annual Update of Baseline Reports A baseline report was not updated annually, on the anniversary month of the initial submission, after the initial baseline report was submitted. Specifically, ***
793 21 CFR 803.53(a) 1 Firm Did Not Submit 5 Day Report A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Specifically, ***
786 21 CFR 803.52(f)(9) 1 Remedial Action Reported per Section 519 An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was reported as a removal or correction under Section 519(f) of the FD&C Act, and listing the correction/removal report number. Specifically, ***
785 21 CFR 803.52(f)(8) 1 Use of device not indicated in Block H An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether use of the device was initial, reuse, or unknown. Specifically, ***
784 21 CFR 803.52(f)(7) 1 Remedial Action Taken An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was taken and type. Specifically, ***
781 21 CFR 803.52(f)(4) 1 Date of Device Manufacture An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the date of device manufacture. Specifically, ***
774 21 CFR 803.52(e)(4) 1 Date Received by Manufacturer An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the date received by the manufacturer. Specifically, ***
766 21 CFR 803.52(d)(1) 1 Name, Address & Phone of Initial Reporter An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block E the [name] [address] [phone number] of the reporter who initially provided information. Specifically, ***
734 21 CFR 803.50(b)(2) 1 Providing Incomplete or Missing Information The firm did not obtain and provide FDA with information that is incomplete or missing from reports submitted by user facilities, distributors, and other initial reporters. Specifically, ***
654 21 CFR 803.20(a)(2) 1 Sections G and H not completed by mfr. The device manufacturer did not complete Sections G and H on the back side of FDA Form 3500A. Specifically, ***
642 21 CFR 803.18(b)(1)(i) 1 Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable. Specifically, ***
641 21 CFR 803.18(a) 1 Identification and filing of MDR Files MDR event files have not been [prominently identified as such] [filed to facilitate timely access]. Specifically, ***
640 21 CFR 803.18(a) 1 Event files--failure to establish MDR event files have not been established and maintained. Specifically, ***
636 21 CFR 803.17(b)(2) 1 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, ***

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Drugs

Center Name Cite Id Ref No Frequency Short Description Long Description
Drugs 1105 21 CFR 211.22(d) 127 Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***
3585 21 CFR 211.110(a) 106 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, ***
2027 21 CFR 211.192 97 Investigations of discrepancies, failures There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***
3603 21 CFR 211.160(b) 84 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, ***
1361 21 CFR 211.100(a) 83 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, ***
1358 21 CFR 211.100(b) 82 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, ***
1883 21 CFR 211.165(a) 61 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, ***
2009 21 CFR 211.188 60 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, ***
1112 21 CFR 211.25(a) 60 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, ***
1215 21 CFR 211.67(b) 54 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, ***
2419 21 CFR 211.198(a) 53 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, ***
1213 21 CFR 211.67(a) 53 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, ***
4314 21 CFR 211.84(d)(2) 50 Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***
1943 21 CFR 211.180(e)(1) 44 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, ***
4576 21 CFR 211.192 43 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, ***
1274 21 CFR 211.68(a) 43 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, ***
2026 21 CFR 211.192 42 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, ***
1890 21 CFR 211.165(e) 41 Test methods The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***
1177 21 CFR 211.63 41 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, ***
1914 21 CFR 211.166(a) 40 Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***
4389 21 CFR 211.198(a) 39 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, ***
4391 21 CFR 211.180(e)(2) 38 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, ***
1133 21 CFR 211.25(a) 38 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, ***
4352 21 CFR 211.160(b)(4) 37 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, ***
4372 21 CFR 211.188(b)(8) 35 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, ***
3570 21 CFR 211.100(a) 35 Approval and review of procedures Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit]. Specifically, ***
1787 21 CFR 211.80(a) 34 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, ***
1767 21 CFR 211.137(a) 32 Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***
2028 21 CFR 211.192 30 Extent of discrepancy, failure investigations Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy]. Specifically, ***
1227 21 CFR 211.67(c) 30 Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***
9001 21 CFR 211.22(a) 29 Lack of quality control unit There is no quality control unit. Specifically, ***
1912 21 CFR 211.166(a) 28 Written program not followed The written stability testing program is not followed. Specifically, ***
1833 21 CFR 211.84(d)(1) 28 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, ***
4303 21 CFR 211.67 b) 27 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, ***
1885 21 CFR 211.165(b) 26 Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***
1920 21 CFR 211.166a)(3) 25 Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***
3602 21 CFR 211.160(a) 24 Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, ***
3572 21 CFR 211.100(b) 24 Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***
1809 21 CFR 211.160(a) 24 Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
1540 21 CFR 211.125(a) 24 Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, ***
1451 21 CFR 211.113(b) 24 Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***
2031 21 CFR 211.194(a) 23 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, , ***
4413 21 CFR 211.194(a)(8) 22 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, ***
4340 21 CFR 211.142 22 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***
3571 21 CFR 211.100(a) 22 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, ***
6732 21 CFR 314.80(c)(1)(i) 21 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, ***
2007 21 CFR 211.186(a) 21 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, ***
1942 21 CFR 211.180(e) 21 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, ***
1450 21 CFR 211.113(a) 21 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, ***
2034 21 CFR 211.194(d) 20 Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
1975 21 CFR 211.182 20 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***
1550 21 CFR 211.125(f) 20 Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
6730 21 CFR 314.80(b) 19 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, ***
4402 21 CFR 211.192 19 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, ***
2619 21 CFR 211.198(b)(2) 17 Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, ***
1810 21 CFR 211.160(a) 17 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, ***
4406 21 CFR 211.194(a)(2) 16 Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
4368 21 CFR 211.188(b)(12) 16 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, ***
4306 21 CFR 211.80(a) 16 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, ***
1891 21 CFR 211.165(f) 16 Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***
1626 21 CFR 211.130 16 Procedures are written, and followed Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, ***
1111 21 CFR 211.25(a) 16 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, ***
4336 21 CFR 211.150 15 Written distribution procedure Written distribution procedures are not [established] [followed]. Specifically, ***
3583 21 CFR 211.110(a) 15 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, ***
3547 21 CFR 211.46(b) 15 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, ***
1801 21 CFR 211.84(a) 15 Components withheld from use pending release Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit. Specifically, ***
3565 21 CFR 211.58 14 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, ***
1261 21 CFR 211.68(a) 14 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, ***
4401 21 CFR 211.186(b)(9) 13 Complete instructions, procedures, specifications et. al. Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***
4342 21 CFR 211.142(b) 13 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, ***
4307 21 CFR 211.80(d) 13 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, ***
2205 21 CFR 211.186(b)(9) 13 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, ***
1926 21 CFR 211.166(b) 13 Adequate number of batches on stability An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date. Specifically, ***
1495 21 CFR 211.122(a) 13 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, ***
1452 21 CFR 211.113(b) 13 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, ***
1395 21 CFR 211.103 13 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, ***
1134 21 CFR 211.25(b) 13 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, ***
4373 21 CFR 211.188(b)(7) 12 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, ***
4369 21 CFR 211.188(b)(11) 12 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, ***
3613 21 CFR 211.160(b)(4) 12 Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, ***
1448 21 CFR 211.111 12 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, ***
8911 21 CFR 314.81(b)(1)(ii) 11 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, ***
4366 21 CFR 211.188(a) 11 Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed. Specifically, ***
2008 21 CFR 211.186(a) 11 Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, ***
2003 21 CFR 211.184(c) 11 Individual inventory record Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated batch or lot of drug product. Specifically, ***
1886 21 CFR 211.165(c) 11 Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested]. Specifically, ***
4357 21 CFR 211.166(a) 10 Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***
4353 21 CFR 211.160(b)(4) 10 Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, ***
3639 21 CFR 211.204 10 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, ***
1263 21 CFR 211.68(b) 10 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, ***
6831 21 CFR 314.80(c)(2) 9 Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, ***
4380 21 CFR 211.198(b)(3) 9 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, ***
4315 21 CFR 211.84(d)(2) 9 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, ***
3592 21 CFR 211.110(c) 9 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, ***
3561 21 CFR 211.56(b) 9 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, ***
2033 21 CFR 211.194(c) 9 Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions]. Specifically, ***
2001 21 CFR 211.184(b) 9 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, ***
1976 21 CFR 211.182 9 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, ***
1505 21 CFR 211.122(d) 9 Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***
1388 21 CFR 211.101(d) 9 Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person. Specifically, ***
4418 21 CFR 211.42(b) 8 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, ***
4399 21 CFR 211.186(b)(7) 8 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, ***
4378 21 CFR 211.188(b)(2) 8 Identity of major equipment and lines used Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced. Specifically, ***
4377 21 CFR 211.188(b(3) 8 Identification of each component or in-process material Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced. Specifically, ***
4370 21 CFR 211.188(b)(10) 8 Records of any sampling performed Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced. Specifically, ***
3623 21 CFR 211.170(a) 8 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, ***
3582 21 CFR 211.105(a) 8 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, ***
3559 21 CFR 211.56(a) 8 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, ***
1790 21 CFR 211.80(b) 8 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, ***
1454 21 CFR 211.115(a) 8 Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not [written] [followed]. Specifically, ***
1270 21 CFR 211.68(b) 8 input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***
1169 21 CFR 211.42(a) 8 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, ***
1162 21 CFR 211.28(a) 8 Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***
1033 21 CFR 211.22(a) 8 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, ***
10021 21 CFR 314.98(a) 7 (Flag to indicate ANDA applicant) (DO NOT PRINT ON FDA 483. This cite is to be used as a flag to indicate that the recipient of an FDA 483 involving ADE reporting is the applicant for one or more approved ANDAs, as opposed to approved NDAs. No specifics text is required for this cite.)
4410 21 CFR 211.194(a)(5) 7 Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, ***
4388 21 CFR 211.198(a) 7 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, ***
3632 21 CFR 211.170(b) 7 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, ***
1922 21 CFR 211.166(a)(4) 7 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, ***
1802 21 CFR 211.84(b) 7 Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, ***
1637 21 CFR 211.130(e) 7 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, ***
1633 21 CFR 211.130(d) 7 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, ***
1434 21 CFR 211.42(c)(10)(iv) 7 Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***
1194 21 CFR 211.42(c) 7 Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
6832 21 CFR 314.80(c)(2) 6 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, ***
6823 21 CFR 314.80(c) 6 Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA. Specifically, ***
4412 21 CFR 211.194(a)(7) 6 Signatures and dates--person who performs test Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed]. Specifically, ***
4400 21 CFR 211.186(b)(8) 6 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, ***
4375 21 CFR 211.188(b)(5) 6 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, ***
4367 21 CFR 211.188(b)(13) 6 Examinations for correct labeling Batch production and control records do not include results of examinations made of packaged and labeled products for correct labeling. Specifically, ***
4338 21 CFR 211.150(b) 6 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, ***
3629 21 CFR 211.170(b) 6 Reserve samples identified, representative, stored Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling]. Specifically, ***
3616 21 CFR 211.165(d) 6 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, ***
3445 21 CFR 211.65(a) 6 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, ***
2401 21 CFR 211.194(a)(4) 6 Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***
2200 21 CFR 211.186(b)(4) 6 Variation in the Amount of Components Used The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form. Specifically, ***
2044 21 CFR 211.196 6 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, ***
1844 21 CFR 211.84(d)(2) 6 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, ***
1798 21 CFR 211.82(b) 6 Quarantine Storage of Components Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released. Specifically, ***
1774 21 CFR 211.142(a) 6 Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit. Specifically, ***
1632 21 CFR 211.130(c) 6 Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. Specifically, ***
1546 21 CFR 211.125(d) 6 Destruction of excess labels with lot numbers Excess labeling bearing lot or control numbers is not destroyed. Specifically, ***
1393 21 CFR 211.103 6 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person. Specifically, ***
1168 21 CFR 211.34 6 Consultant Records Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, ***
1098 21 CFR 211.22(c) 6 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, ***
1049 21 CFR 211.22(a) 6 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, ***
8907 21 CFR 314.81(b)(1)(ii) 5 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, ***
4405 21 CFR 211.194(a)(2) 5 Statement of methods and data Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested]. Specifically, ***
4404 21 CFR 211.194(a)(1) 5 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, ***
4374 21 CFR 211.188(b)(6) 5 Inspection of packaging and labeling area Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced. Specifically, ***
4354 21 CFR 211.165(d) 5 Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, ***
4323 21 CFR 211.115(a) 5 Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics. Specifically, ***
4320 21 CFR 211.84(d)(6) 5 Microbiological Contamination Exam Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use. Specifically, ***
3594 21 CFR 211.110(d) 5 Rejected in-process materials not quarantined Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
3548 21 CFR 211.46(c) 5 Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system. Specifically, ***
2618 21 CFR 211.198(b)(1) 5 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, ***
2420 21 CFR 211.198(a) 5 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, ***
2203 21 CFR 211.186(b)(7) 5 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, ***
2035 21 CFR 211.194(e) 5 Stability testing records not included Laboratory records do not include complete records of all stability testing performed. Specifically, ***
1957 21 CFR 211.180(e)(2) 5 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, ***
1928 21 CFR 211.166(c)(1) 5 Homeopathic drugs, assessment of stability There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use]. Specifically, ***
1918 21 CFR 211.166(a)(2) 5 Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, ***
1917 21 CFR 211.166(a)(1) 5 Sample size - test intervals The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, ***
1879 21 CFR 211.180(c) 5 Records not made readily available to FDA Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection. Specifically, ***
1869 21 CFR 211.94(c) 5 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, ***
1791 21 CFR 211.80(c) 5 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, ***
1725 21 CFR 211.134(c) 5 Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, ***
8912 21 CFR 314.81(b)(2) 4 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, ***
6736 21 CFR 314.80(c)(1)(ii) 4 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, ***
4409 21 CFR 211.194(a)(4) 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, ***
4371 21 CFR 211.188(b)(9) 4 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, ***
4364 21 CFR 211.176 4 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, ***
4343 21 CFR 211.160(b)(1) 4 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, ***
4324 21 CFR 211.110(b) 4 In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, ***
4322 21 CFR 211.101(d) 4 Component release checked by 2nd person Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properly identified]. Specifically, ***
3591 21 CFR 211.110(b) 4 In-process materials specifications In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures where appropriate]. Specifically, ***
3569 21 CFR 211.89 4 Quarantine of Rejected Components et. al. Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
2567 21 CFR 211.198(a) 4 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, ***
1927 21 CFR 211.166(b) 4 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, ***
1851 21 CFR 211.84(e) 4 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, ***
1803 21 CFR 211.84(b) 4 Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, ***
1797 21 CFR 211.82(a) 4 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, ***
1636 21 CFR 211.130(e) 4 Packaging line inspection before use Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations. Specifically, ***
1449 21 CFR 211.111 4 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, ***
1411 21 CFR 211.105(b) 4 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, ***
1396 21 CFR 211.42(c)(2) 4 Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition. Specifically,***
1266 21 CFR 211.42(d) 4 Penicillin processing area not kept separate The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use. Specifically, ***
1086 21 CFR 211.22(b) 4 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, ***
1079 21 CFR 211.22(a) 4 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, ***
6840 21 CFR 314.80(f)(1) 3 Wrong form - domestic ADE An FDA Form 3500A has not been completed for each report of a domestic adverse drug experience. Specifically, ***
6829 21 CFR 314.80(c)(2) 3 Failure to report non-alert ADEs Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report. Specifically, ***
6735 21 CFR 314.80(c)(1)(ii) 3 Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, ***
4414 21 CFR 211.204 3 Record information maintained Records of returned drug products are not maintained. Specifically, ***
4411 21 CFR 211.194(a)(6) 3 Test results, comparison with standards not included Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested. Specifically, ***
4408 21 CFR 211.194(a)(3) 3 Weight or measure of sample Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate. Specifically, ***
4382 21 CFR 211.198(b)(2) 3 Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, ***
4376 21 CFR 211.188(b)(4) 3 Weights and measures of components used Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced. Specifically, ***
4359 21 CFR 211.170(a)(1), (b)(1) 3 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.
4356 21 CFR 211.166(b) 3 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, ***
4355 21 CFR 211.165(c) 3 Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product. Specifically, ***
4350 21 CFR 211.160(b)(3) 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, ***
4341 21 CFR 211.142(a) 3 Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit. Specifically, ***
4327 21 CFR 211.122(c) 3 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, ***
4325 21 CFR 211.110(a) 3 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,***
4316 21 CFR 211.84(d)(3) 3 Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, ***
4304 21 CFR 211.68(b) 3 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, ***
3630 21 CFR 211.170(b) 3 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, ***
3581 21 CFR 211.101(d) 3 Verification of component addition Each component is not added to the batch by one person and verified by a second person.. Specifically, ***
3573 21 CFR 211.101(b) 3 Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, ***
3557 21 CFR 211.52 3 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, ***
2032 21 CFR 211.194(b) 3 Test method modification records not maintained Complete records are not maintained of any modification of an established method employed in testing. Specifically, ***
1977 21 CFR 211.182 3 Dedicated equipment: records part of batch record The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record. Specifically, ***
1958 21 CFR 211.180(f) 3 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, ***
1933 21 CFR 211.167(a) 3 Sterility/pyrogens - test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ******
1876 21 CFR 211.180(a), (b) 3 Record maintenance 1 year (except exempt OTC) All records of [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date. Specifically, ***
1868 21 CFR 211.94(b) 3 Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. Specifically, ***
1724 21 CFR 211.134(b) 3 Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations. Specifically, ***
1496 21 CFR 211.122(a) 3 Sampling/testing of labeling/packaging materials Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product. Specifically, ***
1456 21 CFR 211.115(b) 3 Reprocessing/quality control unit Reprocessing was performed without the [review] [approval] of the quality control unit. Specifically, ***
1413 21 CFR 211.42(c)(5) 3 Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, ***
1159 21 CFR 211.28(a) 3 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, ***
1136 21 CFR 211.25(c) 3 Inadequate number of personnel The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
6830 21 CFR 314.80(c)(2) 2 Interval Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an application which was approved less than three years ago] [yearly for an application which was approved three or more years ago]. Specifically, ***
6728 21 CFR 314.80(b) 2 Failure to review ADE information Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers]. Specifically, ***
4417 21 CFR 211.204 2 Associated batches implicated, investigated No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products. Specifically, ***
4416 21 CFR 211.204 2 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity. Specifically, ***
4415 21 CFR 211.204 2 Returned drug products with doubt cast as to safety et. al. Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters]. Specifically, ***
4407 21 CFR 211.194(a)(2) 2 Reference and method not stated Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified]. Specifically, ***
4386 21 CFR 211.198(b) 2 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, ***
4345 21 CFR 211.160(b)(1) 2 Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified]. Specifically, ***
4330 21 CFR 211.130(e) 2 Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, ***
4328 21 CFR 211.122(a) 2 Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, ***
4321 21 CFR 211.101(b) 2 Identification of new containers For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number]. Specifically, ***
4317 21 CFR 211.84(d)(3) 2 Certificates of Testing (Containers, Closures) Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals]. Specifically, ***
4302 21 CFR 211.56(b) 2 Written sanitation procedures not followed Written procedures for sanitation are not followed. Specifically, ***
3641 21 CFR 211.204 2 Record information inclusions Records of returned drug products do not include the [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity] [date of disposition] [ultimate disposition]. Specifically, ***
3631 21 CFR 211.170(b) 2 Investigation of reserve sample deterioration Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained with other stability data]. Specifically, ***
3614 21 CFR 211.160(b)(4) 2 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, ***
3611 21 CFR 211.160(b)(3) 2 Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, ***
3560 21 CFR 211.56(a) 2 Trash and organic waste timely disposal There is no provision to hold and dispose of [trash] [organic waste matter] in a timely and sanitary manner. Specifically, ***
3553 21 CFR 211.48(a) 2 Plumbing System Defects The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, ***
3551 21 CFR 211.46(d) 2 Penicillin air handling systems not kept separate Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate from those for other drug products for human use. Specifically, ***
2024 21 CFR 211.188(b)(12) 2 Documentation of Batch Investigations The batch production and control records are deficient in that they do not include documentation of batch investigations performed. Specifically, ***
2020 21 CFR 211.188(b)(8) 2 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, ***
2019 21 CFR 211.188(b)(7) 2 Documentation of Actual Yield and Theoretical Yield The batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical yield]. Specifically, ***
2004 21 CFR 211.184(d) 2 Labeling: documentation of exam and review There is no documentation of the examination and review of labels and labeling for conformity with [established specifications] [the assigning of a lot or control number]. Specifically, ***
1978 21 CFR 211.182 2 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, ***
1938 21 CFR 211.167(c) 2 Controlled release dosage form testing Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient. Specifically, ***
1852 21 CFR 211.94(a) 2 Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements. Specifically, ***
1842 21 CFR 211.84(d)(1) 2 Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,***
1796 21 CFR 211.80(d) 2 Identification of Each Lot in Each Shipment Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures]. Specifically, ***
1794 21 CFR 211.80(d) 2 Disposition recorded by lot identification The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, ***
1777 21 CFR 211.150(b) 2 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, ***
1728 21 CFR 211.87 2 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, ***
1722 21 CFR 211.134(a) 2 Correct labels during finishing operations Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, ***
1630 21 CFR 211.130(b) 2 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, ***
1509 21 CFR 211.122(h) 2 Printing devices Printing devices used to imprint labeling upon the drug product [unit label] [case] are not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
1498 21 CFR 211.122(b) 2 Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, ***
1433 21 CFR 211.42(c)(10)(iii) 2 Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, ***
1409 21 CFR 211.42(c)(4) 2 In-Process Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials. Specifically, ***
1384 21 CFR 211.101(c) 2 Weighing/measuring/subdividing operations Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, ***
1256 21 CFR 211.68(b) 2 Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***
1224 21 CFR 211.67(b)(6) 2 Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, ***
1220 21 CFR 211.67(b)(3) 2 Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance. Specifically, ***
8914 21 CFR 314.81(b)(2)(iv)(b) 1 Mfg and control changes not requiring a supplemental app. An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.Specifically, ***
8910 21 CFR 314.81(b)(2)(iii) 1 Labeling information An annual report did not include [currently used professional labeling] [patient brochures or package inserts] [a representative sample of the package labels] [a summary of any changes in labeling that have been made since the last report, listed by date in the order in which they were implemented, or if no changes, a statement of that fact]. Specifically, ***
8906 21 CFR 314.81(b)(1)(i) 1 Mix-up An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another article. Specifically, ***
6838 21 CFR 314.80(e)(1) 1 Failure to report post-marketing study ADEs Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience. Specifically, ***
6835 21 CFR 314.80(d)(1) 1 Failure to submit scientific article Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article. Specifically, ***
6833 21 CFR 314.80(c)(2)(ii) 1 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, ***
6826 21 CFR 314.80(c)(1)(iii) 1 Records not maintained by non-applicant You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected. However, you did not maintain complete records of these submissions, including [the date you received the information] [a copy of each adverse drug experience report] [the date the report was submitted to the applicant] [the name and address of the applicant]. Specifically, ***
6825 21 CFR 314.80(c)(1)(iii) 1 Non-applicant reports to applicant You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected. However, you did not submit each report to the applicant [within five calendar days of your receipt of the information]. Specifically, ***
6737 21 CFR 314.80(c)(1)(ii) 1 Failure to separately submit original and follow-up reports Initial post marketing 15-day Alert reports and follow-up reports have not been submitted under separate cover. Specifically, ***
6714 21 CFR 310.305(c)(3) 1 Untimely submission by packer/distributor Reports of serious adverse drug experiences were not submitted by a [packer] [distributor] to the manufacturer within 5 calendar days of receipt of the report. Specifically, ***
6710 21 CFR 310.305(c)(2) 1 Submission of report follow-up Follow-up reports to post marketing 15-day Alert reports have not been submitted [within 15 calendar days of receipt of new information] [upon request by FDA] . Specifically, ***
6709 21 CFR 310.305(c)(2) 1 Investigation of serious, unexpected events Serious, unexpected adverse drug experiences have not been [promptly] investigated. Specifically, ***
6706 21 CFR 310.305(c)(1)(i) 1 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, ***
6705 21 CFR 310.305(c) 1 Failure to report Adverse drug experience information has not been reported to FDA. Specifically, ***
4403 21 CFR 211.194(b) 1 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, ***
4396 21 CFR 211.186(b)(4) 1 Variations in component amounts not justified The master production and control records indicate unjustified variations in the amount of components necessary for preparation of the dosage form. Specifically, ***
4392 21 CFR 211.186(b)(1) 1 Name, strength, dosage form The master production and control records do not include [the name and strength of the product] [a description of the dosage form]. Specifically, ***
4387 21 CFR 211.198(a) 1 Reporting of adverse drug experience to FDA Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration. Specifically, ***
4383 21 CFR 211.198(b)(1) 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, ***
4381 21 CFR 211.198(b)(2) 1 Written investigation record or copy kept at establishment The written record or copy of the record of an investigation of a complaint conducted in relation to [any unexplained discrepancy] [ the failure of a batch or any of its components to meet any of its specifications] is not maintained at the establishment where the investigation occurred.
4379 21 CFR 211.188(b)(1) 1 Dates not included for each significant step Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, ***
4362 21 CFR 211.170(a)(3), (b)(3) 1 Retention time for exempt OTC drug products Reserve samples for [active ingredients in OTC drug products] [OTC drug products] which are exempt from bearing an expiration date are not retained for 3 years after the lot or batch of drug product is distributed. Specifically, ***
4360 21 CFR 211.170(b) 1 Reserve drug product sample quantity - all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product. Specifically, ***
4351 21 CFR 211.160(b)(3) 1 Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, ***
4349 21 CFR 211.160(b)(2) 1 In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, ***
4348 21 CFR 211.160(b)(2) 1 In-process materials - sampling, testing procedures Laboratory controls do not include a description of [sampling] [testing] procedures for in-process materials. Specifically, ***
4346 21 CFR 211.160(b)(1) 1 Retesting when subject to deterioration Procedures designed to assure conformance to written specifications do not require appropriate retesting of [components] [drug product containers] [closures] subject to deterioration. Specifically, ***
4344 21 CFR 211.160(b)(1) 1 Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, ***
4329 21 CFR 211.122(b) 1 Rejection of unapproved labeling/packaging materials Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable. Specifically, ***
4313 21 CFR 211.84(c)(6) 1 Containers Marked to Show Samples Taken Containers from which samples have been taken are not marked to show that samples have been taken from them. Specifically, ***
4311 21 CFR 211.84(c)(4) 1 Compositing of Sub Samples Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing. Specifically, ***
3640 21 CFR 211.204 1 Returned drug products identified and held Returned drug products are not [identified as such] [held]. Specifically, ***
3625 21 CFR 211.170(a)(1) 1 Retention time for reserve samples of actives Reserve samples of active drug ingredients are deficient in that they are not retained at least one year after the expiration date of the last lot of the drug containing the active drug ingredient. Specifically, ***
3615 21 CFR 211.160(b)(4) 1 Test devices not meeting specifications Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used. Specifically, ***
3609 21 CFR 211.160(b)(2) 1 In-process sample representation/identification In-process samples are not [representative] [properly identified]. Specifically, ***
3608 21 CFR 211.160(b)(2) 1 Sampling/testing of in-process materials The specifications for in-process materials are deficient in that they do not include a description of the [sampling plan] [testing procedures] for in-process materials. Specifically, ***
3598 21 CFR 211.132(b)(1) 1 OTC products requiring tamper-evident packaging OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging are not sold in tamper-evident packages. Specifically, ***
3589 21 CFR 211.110(a)(4) 1 Dissolution time and rate The in-process control procedures are deficient regarding examination of dissolution time and rate. Specifically, ***
3588 21 CFR 211.110(a)(3) 1 Mixing adequacy The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity. Specifically, ***
3562 21 CFR 211.56(c) 1 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, ***
3558 21 CFR 211.52 1 Washing and toilet facilities not provided and accessible Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
3550 21 CFR 211.46(c) 1 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, ***
3546 21 CFR 211.46(a) 1 Adequate ventilation not provided Adequate ventilation is not provided. Specifically, ***
3545 21 CFR 211.44 1 Adequate lighting not provided Adequate lighting is not provided in all areas. Specifically, ***
2621 21 CFR 211.198(b)(3) 1 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, ***
2569 21 CFR 211.198(b) 1 Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints. Specifically, ***
2406 21 CFR 211.194(a)(8) 1 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, ***
2405 21 CFR 211.194(a)(7) 1 Identification of Person Performing the Testing Laboratory records are deficient in that they do not include the [initials] [signature] of the person performing the tests and the dates the tests were performed. Specifically, ***
2199 21 CFR 211.186(b)(4) 1 Component Weight and Measure The master production and control record are deficient in that they do not include an accurate statement of [weight] [measure] of each component, using the same weight system for each component. Specifically, ***
2197 21 CFR 211.186(b)(2) 1 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, ***
2089 21 CFR 211.208 1 No records maintained No records are maintained for salvaged drug products. Specifically, ***
2086 21 CFR 211.208 1 Salvaging and return to marketplace Drug products that have been subjected to improper storage conditions were salvaged and returned to the marketplace without further evidence or inspection. Specifically, ***
2023 21 CFR 211.188(b)(11) 1 Identification of Persons Performing Significant Steps The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation. Specifically, ***
2018 21 CFR 211.188(b)(6) 1 Documentation of Packaging and Labeling Area Inspections The batch production and control records are deficient in that they do not include documentation of the inspection of the [packaging] [labeling] area before and after use. Specifically, ***
2011 21 CFR 211.188(a) 1 Accurate reproduction The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed]. Specifically, ***
2005 21 CFR 211.184(e) 1 Records of disposition of rejected material Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling]. Specifically, ***
1979 21 CFR 211.182 1 Chronological Order of Equipment Log Entries The entries in the equipment cleaning and use logs are not in chronological order. Specifically, ***
1929 21 CFR 211.166(c)(2) 1 Homeopathic drugs, same container - closure The evaluation of the stability of homeopathic drug products is not based on the same container-closure system in which the drug product is being marketed. Specifically, ***
1870 21 CFR 211.94(d) 1 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, ***
1843 21 CFR 211.84(d)(2) 1 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, ***
1819 21 CFR 211.84(c)(3) 1 Sterile/Aseptic Techniques for Sampling Sampling procedures are deficient regarding sterile equipment and aseptic sampling techniques when sampling [components] [drug product containers] [closures]. Specifically, ***
1768 21 CFR 211.137(b) 1 Storage conditions Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, ***
1726 21 CFR 211.86 1 Rotation of components/containers/closures There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first. Specifically, ***
1629 21 CFR 211.130(a) 1 Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination. Specifically, ***
1545 21 CFR 211.125(c) 1 Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated]. Specifically, ***
1503 21 CFR 211.122(c) 1 Records not kept for each shipment Records are not maintained for each shipment received of each different labeling and packaging material. Specifically, ***
1436 21 CFR 211.42(c)(10)(vi) 1 Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, ***
1435 21 CFR 211.42(c)(10)(v) 1 Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***
1430 21 CFR 211.42(c)(10)(i) 1 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,***
1421 21 CFR 211.42(c)(10) 1 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,***
1420 21 CFR 211.42(c)(9) 1 Control / Lab Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. Specifically, ***
1418 21 CFR 211.42(c)(7) 1 Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release. Specifically, ***
1371 21 CFR 211.101(a) 1 Batches Formulated to less than 100% Written production and control procedures include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient. Specifically, ***
1251 21 CFR 211.42(c)(1) 1 Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. Specifically, ***
1219 21 CFR 211.67(b)(2) 1 Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
1174 21 CFR 211.42(b) 1 Product flow through building is inadequate The flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination. Specifically, ***
1167 21 CFR 211.34 1 Qualifications lacking Consultants lack sufficient education, training and experience to advise on the subject for which they are retained. Specifically, ***
1164 21 CFR 211.28(c) 1 Unauthorized Personnel in Limited Access Areas Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas. Specifically, ***
1163 21 CFR 211.28(b) 1 Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits. Specifically, ***

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Bioresearch monitoring

Center Name Cite Id Ref No Frequency Short Description Long Description
Bioresearch monitoring 7560 21 CFR 312.60 128 FD-1572, protocol compliance An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically***
7530 21 CFR 312.62(b) 77 Case history records- inadequate or inadequate Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***
7526 21 CFR 312.62(a) 30 Accountability records Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].Specifically, ***
7318 21 CFR 56.115(a)(2) 29 Minutes of IRB meetings Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***
7227 21 CFR 50.27(a) 26 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, ***
7281 21 CFR 56.108(a)(1) 26 Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
7290 21 CFR 56.108(c) 18 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, ***
7498 21 CFR 312.66 18 Unanticipated problems Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***
7342 21 CFR 56.108(b)(2) 15 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, ***
7334 21 CFR 56.115(a)(5) 14 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, ***
7231 21 CFR 50.20 13 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, ***
7562 21 CFR 312.60 13 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***
7293 21 CFR 56.109(f) 10 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, ***
7321 21 CFR 56.110(c) 10 Method to keep members advised The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***
7552 21 CFR 312.66 10 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***
7278 21 CFR 56.107(e) 9 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, ***
7286 21 CFR 56.108(b)(1) 9 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, ***
7335 21 CFR 56.115(a)(6) 9 Written procedures per 56.108(a) and (b) Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***
7343 21 CFR 56.108(b)(3) 9 Reporting of suspension/termination The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval . Specifically, ***
7317 21 CFR 56.115(a)(1) 8 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, ***
7482 21 CFR 312.50 8 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, ***
7340 21 CFR 56.108(a)(3) 7 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, ***
7391 21 CFR 50.25(a)(5) 7 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, ***
4006 21 CFR 58.120(b) 6 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, ***
7368 21 CFR 56.108(a)2) 6 More frequent reviews, verification of no changes The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, ***
7369 21 CFR 56.109(h) 6 Children as subjects The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50 Subpart D, "Additional Safeguards for Children in Clinical Investigations." Specifically, ***
7390 21 CFR 50.25(a)(4) 6 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, ***
7517 21 CFR 312.66 6 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, ***
7520 21 CFR 312.64(b) 6 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, ***
3956 21 CFR 58.63(c) 5 Equipment: maintenance records Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***
7316 21 CFR 56.115(a)(4) 5 Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***
7320 21 CFR 56.109(e) 5 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, ***
7371 21 CFR 56.108(a)(1) 5 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, ***
7527 21 CFR 312.62(a) 5 Unused drug disposition (investigator) Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions]. Specifically, ***
7652 21 CFR 56.113 5 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, ***
7654 21 CFR 56.110(b) 5 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, ***
3914 21 CFR 58.31(f) 4 Management: personnel understand their functions Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***
3923 21 CFR 58.33(f) 4 Study director: transfer of data to archives The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***
3931 21 CFR 58.35(b)(5) 4 QAU: authorize deviations from protocols or SOPs The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation. Specifically, ***
3951 21 CFR 58.51 4 Facility: archives Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***
3952 21 CFR 58.61 4 Equipment: appropriate design and adequate capacity Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically, ***
3960 21 CFR 58.81(b) 4 SOPs: required Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals]. Specifically, ***
3977 21 CFR 58.90(g) 4 Animal care: analysis of feed and water Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***
3997 21 CFR 58.120(a)(4) 4 Protocol: test system description Not all protocols contained the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system. Specifically, ***
4007 21 CFR 58.130(a) 4 Conduct: in accordance with protocol Not all nonclinical laboratory studies were conducted in accordance with the protocol. Specifically, ***
7279 21 CFR 56.107(f) 4 Invited individual allowed to vote with IRB The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB. Specifically, ***
7319 21 CFR 56.115(a)(3) 4 Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
7353 21 CFR 50.52 4 Factors required for approval The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being. However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55]. Specifically, ***
7370 21 CFR 56.111(c) 4 Children as subjects The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D. Specifically, ***
7392 21 CFR 50.25(a)(7) 4 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, ***
7459 21 CFR 312.57(a) 4 Records of receipt, shipment, disposition Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***
7480 21 CFR 312.50 4 Ensuring compliance with plan and protocol Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***
7488 21 CFR 312.59 4 Records of unused drug disposition Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57. Specifically, ***
7531 21 CFR 312.62(c) 4 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, ***
3918 21 CFR 58.33(a) 3 Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***
3920 21 CFR 58.33(c) 3 Study director: unforeseen circumstances The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***
3926 21 CFR 58.35(b)(1) 3 QAU: maintain a master schedule The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***
3932 21 CFR 58.35(b)(6) 3 QAU: review final study report The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***
3953 21 CFR 58.63(a) 3 Equipment: inspection, cleaning and maintenance Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
3954 21 CFR 58.63(a) 3 Equipment: calibration Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***
3958 21 CFR 58.81(a) 3 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, ***
3999 21 CFR 58.120(a)(6) 3 Protocol: experimental design Not all protocols contained a description of the experimental design, including the methods for the control of bias. Specifically, ***
4012 21 CFR 58.130(e) 3 Conduct: date and sign Not all data entries were dated on the date of entry and signed or initialed by the person entering the data. Specifically, ***
4016 21 CFR 58.185(a) 3 Final report: non-existent A final report was not prepared for each nonclinical laboratory study. Specifically, ***
4037 21 CFR 58.190(b) 3 Archives: conditions of storage Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time period of their retention and the nature of the [documents] [specimens]. Specifically, ***
7324 21 CFR 56.111(a)(4) 3 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, ***
7638 21 CFR 312.20(a) 3 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,***
7664 21 CFR 50.20 3 Circumstances of obtaining consent The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***
7666 21 CFR 50.20 3 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, ***
3903 21 CFR 58.29(b) 2 Personnel: summary of training, job description The testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically, ***
3911 21 CFR 58.31(c) 2 Management: assure there is a QAU Testing facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations. Specifically, ***
3925 21 CFR 58.35(a) 2 QAU: separate and independent The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Specifically, ***
3957 21 CFR 58.81(a) 2 SOPs: laboratory methods The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***
3959 21 CFR 58.81(a) 2 SOPs: authorized changes Not all significant changes in established standard operating procedures were properly authorized in writing by management. Specifically, ***
3978 21 CFR 58.90(g) 2 Animal care: feed and water analysis records Not all feed and water analyses for contaminants were maintained as raw data. Specifically, ***.
3983 21 CFR 58.105(a) 2 Test article: characterization The identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately defined and documented. Specifically, ***
3985 21 CFR 58.105(b) 2 Test article: stability The stability of each test or control article was not determined by the testing facility or by the sponsor before study initiation, or concomitantly according to written standard operating procedures which provide for periodic analysis of each batch. Specifically, ***
3989 21 CFR 58.107 2 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, ***
4018 21 CFR 58.185(a)(2) 2 Final report: objectives, procedures, changes The final study report did not include the objectives and procedures stated in the approved protocol, including any changes in the original protocol. Specifically, ***
4020 21 CFR 58.185(a)(4) 2 Final report: data on test and control articles The final study report did not include the test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. Specifically, ***
4021 21 CFR 58.185(a)(5) 2 Final report: stability of test and control articles The final study report did not include the stability of the test and control articles under the conditions of administration. Specifically, ***
4025 21 CFR 58.185(a)(9) 2 Final report: circumstances affecting data qual., integrity The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***
4028 21 CFR 58.185(a)(12) 2 Final report: reports of individual scientists The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study. Specifically, ***
4035 21 CFR 58.190(a) 2 Archives: data, documentation, specimens Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***
7274 21 CFR 56.107(a) 2 At least five members with varying backgrounds The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution]. Specifically, ***
7297 21 CFR 56.109(b) 2 Information given to subjects The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent. Specifically, ***:
7305 21 CFR 56.110(b)(2) 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, ***
7309 21 CFR 56.111(a)(1) 2 Risks minimized by sound research design The IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were consistent with sound research design and which did not unnecessarily expose subjects to risk. Specifically, ***
7325 21 CFR 56.111(a)(5) 2 Informed consent documented The IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented. Specifically, ***
7372 21 CFR 56.115(b) 2 Access to records Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the FDA. Specifically, ***
7387 21 CFR 50.25(a)(1) 2 Statement of research, purpose, duration of participation The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation]. Specifically, ***
7388 21 CFR 50.25(a)(2) 2 Reasonably foreseeable risks or discomforts The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***
7411 21 CFR 312.53(c)(1) 2 Investigator statement (FDA 1572) Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***
7555 21 CFR 312.53(d) 2 Selecting monitors Monitors not qualified by experience and training were selected to monitor the progress of a clinical investigation. Specifically, ***
7650 21 CFR 56.113 2 Authority of the IRB The IRB lacks authority to [suspend] [terminate approval of] research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Specifically, ***
7656 21 CFR 56.108(c) 2 Approval from a majority of members present For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present. Specifically, ***
3900 21 CFR 58.10 1 Notifying contractor of GLP status Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations. Specifically, ***
3902 21 CFR 58.29(a) 1 Personnel: education, training, experience Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***
3904 21 CFR 58.29(c) 1 Personnel: sufficient number The testing facility did not have a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. Specifically, ***
3909 21 CFR 58.31(a) 1 Management: designating the study director Testing facility management failed to designate a study director before each study was initiated. Specifically, ***
3912 21 CFR 58.31(d) 1 Management: testing of test and control articles Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. Specifically, ***
3917 21 CFR 58.33 1 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, ***
3919 21 CFR 58.33(b) 1 Study director: all data recorded and verified The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***
3922 21 CFR 58.33(e) 1 Study director: follow GLP regulations The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
3924 21 CFR 58.35(a) 1 QAU: monitor facilities, etc. The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***
3928 21 CFR 58.35(b)(3) 1 QAU: inspect study at adequate intervals The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. Specifically, ***
3933 21 CFR 58.35(b)(7) 1 QAU: signed statement in final report The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director. Specifically, ***
3934 21 CFR 58.35(c) 1 QAU: SOPs and required records The quality assurance unit failed to maintain and make available for inspection required records regarding its responsibilities and procedures and the method of indexing such records. Specifically, ***
3936 21 CFR 58.41 1 Facility: suitable size and construction The testing facility is not of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. Specifically, ***
3946 21 CFR 58.47(a)(1) 1 Facility: article receipt and storage areas The testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for receipt and storage of the test and control articles. Specifically, ***
3955 21 CFR 58.63(b) 1 Equipment: maintenance SOPs The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate. Specifically, ***
3962 21 CFR 58.81(d) 1 SOPs: historical file A historical file of standard operating procedures, and all revisions, including the dates of such revisions, was not maintained. Specifically, ***
3963 21 CFR 58.83 1 Reagents: labeling Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Specifically, ***
3976 21 CFR 58.90(f) 1 Animal care: cage and equipment cleaning Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals.Specifically, ***
3990 21 CFR 58.113(a)(1) 1 Mixtures: uniformity and concentration Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in the mixture]. Specifically, ***
3992 21 CFR 58.113(c) 1 Mixtures: expiration dating Not all test or control article carrier mixtures [had an expiration date clearly shown on the container] [consisting of more than one component, had the earliest expiration date clearly shown on the container]. Specifically, ***
3993 21 CFR 58.120(a) 1 Protocol: approved Not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study.Specifically, ***
4000 21 CFR 58.120(a)(7) 1 Protocol: diet description Not all protocols contained a description and/or identification of the diet used in the study. Specifically, ***
4004 21 CFR 58.120(a)(11) 1 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, ***
4008 21 CFR 58.130(b) 1 Conduct: test systems monitoring Not all test systems were monitored in conformity with the protocol. Specifically, ***
4011 21 CFR 58.130(e) 1 Conduct: recording in ink Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink. Specifically, ***
4017 21 CFR 58.185(a)(1) 1 Final report: name, address, dates The final study report did not include the name and address of the facility performing the study and the dates on which the study was initiated and completed. Specifically, ***
4022 21 CFR 58.185(a)(6) 1 Final report: description of methods The final study report did not include a description of the methods used. Specifically, ***
4023 21 CFR 58.185(a)(7) 1 Final report: description of test system The final study report did not include a description of the test system used and, where applicable, the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification. Specifically, ***
4024 21 CFR 58.185(a)(8) 1 Final report: dosage, regimen, route of admin., duration The final study report did not include a description of the dosage, dosage regimen, route of administration, and duration. Specifically, ***
4026 21 CFR 58.185(a)(10) 1 Final report: names of those involved The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***
4027 21 CFR 58.185(a)(11) 1 Final report: operations on data, analysis of data The final study report did not include [a description of the transformations, calculations, or operations performed on the data] [a summary and analysis of the data] [a statement of the conclusions drawn from the analysis]. Specifically, ***
4031 21 CFR 58.185(b) 1 Final report: not signed by study director Not all final reports were signed and dated by the study director. Specifically, ***
4040 21 CFR 58.190(d) 1 Archives: unauthorized personnel Unauthorized personnel entered the archives. Specifically, ***
4041 21 CFR 58.190(e) 1 Archives: indexing, expedient retrieval Not all material retained or referred to in the archives was indexed to permit expedient retrieval. Specifically, ***
4044 21 CFR 58.195(d) 1 Archives: maintenance of records by QAU Not all master schedules, copies of protocols, and records of quality assurance inspections were maintained by the quality assurance unit as an easily accessible system of records for the required period of time. Specifically, ***
4047 21 CFR 58.195(g) 1 Archives: records not retained as originals, true copies Not all required records were retained as original records or as true copies of the original records. Specifically, ***
7209 21 CFR 50.25(a)(1) 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, ***
7233 21 CFR 50.23(a) 1 Two written certifications re: no IC A test article was used without informed consent being obtained from a research subject. The investigator and a physician who was not otherwise participating in the investigation did not both certify in writing that [the human subject was confronted by a life-threatening situation necessitating the use of the test article] [informed consent could not be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject] [time was not sufficient to obtain consent from the subject's legal representative] [there was no alternative method of approved or generally recognized therapy available that would provide an equal or greater likelihood of saving the life of the subject]. Specifically, ***
7270 21 CFR 56.103(a) 1 IRB review requirement A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review]. Specifically, ***
7277 21 CFR 56.107(d) 1 One non-affiliate member The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***
7304 21 CFR 56.110(b)(1) 1 No more than minimal risk The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects. Specifically, ***
7313 21 CFR 56.112 1 Approval by institution in absence of IRB approval The institution approved research which had not been approved by the IRB. Specifically, ***
7322 21 CFR 56.111 (a)(2) 1 Risks to subjects reasonable The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result. Specifically, ***
7333 21 CFR 56.104(c) 1 Emergency use and IRB approval A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal. Specifically, ***
7337 21 CFR 56.115(b) 1 Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research.Specifically, ***
7339 21 CFR 56.108(a)(4) 1 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, ***
7352 21 CFR 50.51 1 Provisions for soliciting assent and permission For a clinical investigation in which no greater than minimal risk to children as subjects was presented, the IRB did not [find] [document] that adequate provisions had been made for [soliciting the assent of the children] [soliciting the permission of the parents or guardians of the children] as set forth at 21 CFR 50.55. Specifically, ***
7354 21 CFR 50.53 1 Factors required for approval The IRB approved a study in which more than minimal risk to children was presented by [an intervention or procedure that did not hold out the prospect of direct benefit for the subjects] [a monitoring procedure that was not likely to contribute to the well-being of the subjects]. However, the IRB did not [find] [document] that [the risk represented a minor increase over minimal risk] [the intervention or procedure presented experiences to subjects that were reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations] [the intervention or procedure was likely to yield generalizable knowledge about the subjects' disorder or condition that was of vital importance for the understanding or amelioration of the subjects' disorder or condition] [adequate provisions had been made for soliciting the assent of the children and permission of their parents or guardians]. Specifically, ***
7363 21 CFR 50.55(f) 1 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, ***
7367 21 CFR 50.55(e)(2) 1 Two parents' permission: studies under Parts 50.53 - 50.54 For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the permission of both parents where feasible. Specifically, ***
7383 21 CFR 50.25(b)(6) 1 Number of subjects in study The informed consent document did not state the approximate number of subjects involved in the study. Specifically, ***
7389 21 CFR 50.25(a)(3) 1 Benefits to the subject A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document. Specifically, ***
7393 21 CFR 50.25(a)(8) 1 Participation; refusal and discontinuance The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled]. Specifically, ***
7406 21 CFR 56.109(a) 1 Scope of reviews The IRB does not review all research activities covered by the regulations. Specifically, ***
7453 21 CFR 312.56(b) 1 Investigator non-compliance An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***
7479 21 CFR 312.56(a) 1 Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***
7507 21 CFR 312.52(a) 1 Transfer of obligations Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, ***
7519 21 CFR 312.64(c) 1 Final study report An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation. Specifically, ***
7533 21 CFR 312.69 1 Controlled substances (investigator) Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled substance. Specifically, ***
7543 21 CFR 312.61 1 Unauthorized recipients (investigator) A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. Specifically, ***
7545 21 CFR 312.120(c) 1 Foreign clinical trials Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the "Declaration of Helsinki"] [the laws and regulations of the country in which the research was conducted]. Specifically, ***
7632 21 CFR 312.6(a) 1 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
7634 21 CFR 312.7(a) 1 Promotion of Investigational Drug Representations were made in a promotional context that the investigational drug is [safe] [effective] for the purposes for which it is under investigation. Specifically, ***
7639 21 CFR 312.20(b) 1 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,***
7665 21 CFR 50.20 1 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, ***

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Veterinary medicine

Center Name Cite Id Ref No Frequency Short Description Long Description
Veterinary medicine 4185 FDCA 402(a)(4) 72 Record keeping Treatment records were not [maintained] [complete].Specifically,***
4093 21 CFR 530.11(d) 52 Tissue residue Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling. Specifically, ***
7001 FDCA 402(a)(4) 32 Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, ***
4182 FDCA 501(a)(5) 29 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, ***
1442 FDCA 402(a)(4) 28 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, ***
4298 21 CFR 530.11(a) 19 Rx not followed Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment] [route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary directions].Specifically, ***
4097 21 CFR 530.20(a)(2)(iv) 17 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, ***
1360 FDCA 501(a)(5) 15 Expired drugs Expired drug(s) were observed in the drug storage area. Specifically, ***
1366 21 CFR 530.11(a) 15 Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
1850 21 CFR 225.58(d) 14 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,***
4186 FDCA 402(a)(4) 14 System for administration of drugs Failure to have a system to control administration of drug treatments to your animals. Specifically, ***
1811 21 CFR 225.58(b)(1) 12 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, ***
2076 21 CFR 225.102(b)(1) 12 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, ***
2097 21 CFR 225.102(b)(4) 11 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, ***

1373 21 CFR 530.11(a) 10 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, ***
1575 21 CFR 225.42(b)(4) 9 Integrity and identity Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***
1469 21 CFR 225.20(b)(3) 8 Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
13508 FDCA 402(a)(4) 8 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, ***
1466 21 CFR 225.20(b)(2) 7 Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
1923 21 CFR 225.65(b) 7 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, ***
1955 21 CFR 225.80(a) 7 Appropriate labeling for medicated feed Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the article is safe and effective for its intended purpose. Specifically, ***
2075 21 CFR 225.102(b)(1) 7 Preparation of MRF A Master Record File providing the complete procedure for manufacturing a specific product is not [prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***

4100 21 CFR 530.20(a)(2)(iii) 7 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, ***
4184 FDCA 501(a)(5) 7 Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
4541 21 CFR 225.42(b) 7 Adequate procedures established Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid in assuring their identity, strength, quality and purity when incorporated into products. Specifically, ***
13509 FDCA 402(a)(4) 7 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, ***
1362 21 CFR 530.11(a) 6 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, ***
1493 21 CFR 225.30(b)(4) 6 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, ***
1782 21 CFR 225.42(b)(7) 6 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, ***
4132 21 CFR 589.2000(d)(1) 6 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, ***
1821 21 CFR 225.58(b)(1) 5 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, ***
4137 21 CFR 589.2000(d)(1) 5 Maintaining records Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution.Specifically, ***
4146 21 CFR 589.2000(e)(1) 5 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, ***
4545 21 CFR 225.120 5 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***
1376 21 CFR 530.11(a) 4 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, ***
1744 21 CFR 225.42(b)(6) 4 Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***
2093 21 CFR 225.102(b)(2)(i)-(iv) 4 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, ***
4113 21 CFR 530.12(e) 4 Withdrawal, withholding, or discard time Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4145 21 CFR 589.2000(e)(1) 4 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, ***
4547 21 CFR 225.130 4 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, ***
4557 21 CFR 225.158 4 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, ***
1262 21 CFR 225.10(b)(2) 3 Evaluation and supervision of employees Failure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds. Specifically, ***
1389 21 CFR 530.11(a) 3 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, ***
1465 21 CFR 225.20(b)(1) 3 Building grounds maintenance The building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass] [improperly stored equipment]. Specifically, ***

1638 21 CFR 225.42(b)(5) 3 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, ***
1760 21 CFR 225.42(b)(6) 3 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, ***
1765 21 CFR 225.42(b)(6)(i) - (v) 3 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, ***
1882 21 CFR 225.58(e) 3 Subsequent production Following distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feedwas resumed prior to the establishment of proper control procedures. Specifically, ***
1930 21 CFR 225.65(b)(3) 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, ***
2098 21 CFR 225.102(b)(4) 3 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, ***



4111 21 CFR 530.12(c) 3 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, ***
4115 21 CFR 530.13(a) 3 From bulk drugs Compounding an animal drug from a bulk drug. Specifically, ***
4552 21 CFR 225.142 3 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, ***
1446 FDCA 402(a)(4) 2 Hospital pen Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
1535 21 CFR 225.42(b)(2) 2 Storage of packaged drugs Packaged drugs are not storedin their original closed containers. Specifically, ***
1792 21 CFR 225.42(b)(7) 2 Discrepancies Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage. Specifically, ***
1835 21 CFR 225.58(c) 2 Assay results kept one year Failure to maintain on the premises, originals or copies of all results of assays [including those from State feed control officials or any other governmental agency] for a period of not less than one year after distribution of the medicated feed. Specifically, ***
1953 21 CFR 225.80(b)(2) 2 Maintaining proofread label Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the labels from that batch have been used]. Specifically, ***
2074 21 CFR 225.102(a) 2 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, ***
2232 21 CFR 225.115(b)(1) 2 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, ***
2234 21 CFR 225.115(b)(2) 2 Records of clinical and other experiences Failure to [maintain] [report] records and reports of clinical and other experience with medicated feeds whose manufacture requires a medicated feed mill license. Specifically, ***
4094 21 CFR 530.11(b) 2 Use in animal feed An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
4099 21 CFR 530.20(a)(2)(ii) 2 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, ***
4118 21 CFR 530.13(b)(3) 2 Outside of scope of professional practice Compounding of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the scope of a professional practice. Specifically, ***
4131 21 CFR 589.2000(c)(1)(i) 2 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, ***
4144 21 CFR 589.2000(e)(1) 2 Separate equipment and facilities Failure to maintain separate [equipment] [facilities] for the manufacture, processing, or blending of protein derived from mammalian tissues, to avoid commingling with or cross-contamination of products containing non-mammalian protein. Specifically, ***
4147 21 CFR 589.2000(e)(1) 2 Written product separation procedures Failure to maintain procedures for separating products which may contain protein derived from mammalian tissues from all other protein products, from the time of receipt until the time of shipment. Specifically, ***
4183 FDCA 501(a)(5) 2 Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].Specifically, ***
4548 21 CFR 225.130 2 Scales and metering devices The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose. Specifically, ***
4553 21 CFR 225.142 2 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, ***
4560 21 CFR 225.165 2 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, ***
1447 FDCA 402(a)(4) 1 Feeding areas Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids. Specifically, ***
1457 FDCA 402(a)(4) 1 Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
1464 21 CFR 225.20(b)(1) 1 Adequate drainage The building grounds are not adequately drained so that they are free from standing water. Specifically, ***
1482 21 CFR 225.30(b)(1) 1 Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, ***
1491 21 CFR 225.30(b)(2) 1 Maintenance reasonably clean & orderly Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
1492 21 CFR 225.30(b)(3) 1 Suitable for intended purpose Equipment is not of suitable [size] [design] [construction] [precision] [accuracy] for its intended purpose. Specifically, ***
1510 21 CFR 225.35(b) 1 Pesticide manufacture and storage Work areas and equipment used in the [manufacture] [storage] of medicated feeds or components thereof are not physically separated from [work areas] [equipment used] for the [manufacture] [storage] of [fertilizers] [herbicides] [insecticides] [fungicides] [rodenticides] [pesticides]. Specifically, ***
1634 21 CFR 225.42(b)(5) 1 Receipt for each lot of drug received Failure to [prepare] [maintain] a receipt record for each lot of drug received. Specifically, ***
1778 21 CFR 225.42(b)(8) 1 Maintenance Time Requirement Records are not maintained on the premises for at least one year after the complete use of a drug component of a specific manufacturer's lot number or shipment identification number. Specifically, ***
1880 21 CFR 225.58(e) 1 Distribution discontinued Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued. Specifically, ***
1952 21 CFR 225.80(b)(2) 1 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, ***
2091 21 CFR 225.102(b)(2) 1 Preparation of Production Records The production record is not prepared by qualified personnel for each batch or run of medicated feed. Specifically, ***
2140 21 CFR 225.102(b)(5) 1 Identification which permits tracing history Failure to have identification which permits the tracing of the complete and accurate manufacturing history of the product by the manufacturer, including [an individual batch or production run number, code or date] [suitable identification applied to the label, package, invoice or shipping document]. Specifically, ***
2359 21 CFR 226.58(e) 1 Test method reliability Laboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures. Specifically, ***

2376 21 CFR 226.40(c) 1 Equipment maintenance and operation Equipment is not [maintained] [operated] in a manner [to avoid contamination of Type A medicated articles] [to insure integrity of the finished products]. Specifically, ***
2658 21 CFR 226.102(b)(2) 1 Records do not include The batch-production and control records do not include [records of each step in the manufacturing, packaging, labeling and controlling of each batch] [dates] [specific identification of drug components used] [weights or measures of all components] [laboratory control results] [mixing times] [endorsements of the individual actively performing or the individual actively supervising or checking each step in the operation]. Specifically, ***
4098 21 CFR 530.20(a)(2)(i) 1 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, ***
4109 21 CFR 530.12(a) 1 Name and address - drug dispensed by pharmacist Failure to provide labeling showing the [name of the prescribing veterinarian] [name and address of the dispensing pharmacist] for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4110 21 CFR 530.12(b) 1 Names of active ingredients Failure to provide labeling showing the established name of each active ingredient for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4112 21 CFR 530.12(d) 1 Cautionary statements Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4134 21 CFR 589.2000(c)(1)(ii) 1 Maintaining records Manufacture of products that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution. Specifically, ***
4155 21 CFR 226.115 1 Appropriate action not taken Appropriate action is not taken as a result of evaluation of complaints on Type A medicated articles. Specifically, ***
4157 21 CFR 225.42(b)(7) 1 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, ***
4158 21 CFR 225.80(b)(4) 1 Label stock review Label stock is not [reviewed periodically] [discarded when discontinued labels are found]. Specifically, ***
4453 21 CFR 225.10(b)(1) 1 Employees lack understanding All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment]. Specifically, ***
4454 21 CFR 225.20(a) 1 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, ***
4542 21 CFR 225.102((a) 1 Lack of Production Record(s) Failure to have production record(s) for specific products which include the complete history of each batch or production run.Specifically, ***
4554 21 CFR 225.142 1 Bulk Type A and Type B storage Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality and purity will be maintained. Specifically, ***
4555 21 CFR 225.142 1 Use in accord with directions All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***
4558 21 CFR 225.158 1 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, ***
4562 21 CFR 225.180 1 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, ***
4564 21 CFR 225.180 1 Bagged or bulk deliveries All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used. Specifically, ***
4566 21 CFR 225.202 1 Elements of records Formula, production and distribution records are not maintained identifying the [formulation] [date of mixing] [date of shipment (if not for own use)]. Specifically, ***
4567 21 CFR 225.202 1 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, ***
13534 21 CFR 511.1(b)(7)(ii) 1 Records: Maintenance Complete records of the investigation were not maintained. Specifically, ***

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Biologics

Center Name Cite Id Ref No Frequency Short Description Long Description
Biologics 76 21 CFR 606.100(b) 168 Maintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises]. Specifically, ***
98 21 CFR 606.100(c) 44 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,***
4425 21 CFR 606.60(a) 37 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, ***
155 21 CFR 606.160(b) 35 Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***
160 21 CFR 606.160(a)(1) 34 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, ***
9225 21 CFR 606.171 27 Biological product deviation report Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred]. Specifically, ***
154 21 CFR 606.160(a)(1) 22 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, ***
31 21 CFR 606.20(b) 20 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, ***
161 21 CFR 606.160(a)(2) 18 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, ***
67 21 CFR 606.65(e) 16 Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, ***
77 21 CFR 606.100(b) 13 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, ***
78 21 CFR 606.100(c) 13 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, ***
94 21 CFR 606.100(b)(15) 13 Schedules and procedures for equipment & calibration The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration. Specifically, ***
208 21 CFR 640.3(a)(1) 13 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, ***
9044 21 CFR 600.10(b) 12 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, ***
50 21 CFR 606.40(c) 11 Provide adequate handwashing Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel. Specifically, ***
57 21 CFR 606.60(a) 10 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, ***
89 21 CFR 606.100(b)(10) 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, ***
159 21 CFR 606.160(a)(1) 10 Legibility and indelibility Records are [illegible] [not indelible]. Specifically, ***
227 21 CFR 640.4(h) 9 Storage temperatures after collection After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius] [transported from the donor clinic to the processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius].Specifically, ***
9089 21 CFR 600.14(c) 9 When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***
12202 21 CFR 606.170(a) 9 Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made. Specifically,
224 21 CFR 640.4(f) 8 Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, ***
9086 21 CFR 600.14(a)(1) 8 Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports]. Specifically, ***
12203 21 CFR 606.170(a) 8 Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically,
65 21 CFR 606.65(c) 7 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, ***
150 21 CFR 606.151(e) 7 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, ***
255 21 CFR 640.31 7 Donor suitability Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
9220 21 CFR 606.100(b)(20) 7 Donor notification The standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial attempt at donor notification fails]. Specifically, ***
93 21 CFR 606.100(b)(14) 6 QC procedures for supplies and reagents The standard operating procedure fails to include a written description of the quality control procedures for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing]. Specifically, ***
142 21 CFR 606.140(a) 6 Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective. Specifically, ***
165 21 CFR 606.170(a) 6 Adverse reaction - Maintenance of Reports Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of [blood collection] [transfusion]. Specifically, ***
88 21 CFR 606.100(b)(9) 5 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, ***
143 21 CFR 606.140(b) 5 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, ***
167 21 CFR 606.170(b) 5 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, ***
41 21 CFR 606.40(a)(1) 4 Provide space for examination Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors. Specifically, ***
61 21 CFR 606.60(a) 4 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, ***
9087 21 CFR 600.14(a)(1) 4 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, ***
9219 21 CFR 606.100(b)(20) 4 Donor deferral The standard operating procedure fails to include a written description of the donor deferral process. Specifically, ***
9227 21 CFR 606.171(a) 4 BPDR - procedures Failure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor. Specifically, ***
9596 21 CFR 640.3(a) 4 Donor suitability by means of medical history Failure to [always] determine donor suitability on the day of collection by means of [medical history] [test for hemoglobin level] [physical examination]. Specifically, ***
35 21 CFR 606.40 3 Clean & orderly Failure to maintain facilities in a clean and orderly manner. Specifically, ***
75 21 CFR 606.100(a) 3 SOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically, ***
80 21 CFR 606.100(b)(1) 3 Donor criteria The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria. Specifically, ***
84 21 CFR 606.100(b)(5) 3 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, ***
85 21 CFR 606.100(b)(6) 3 Methods of component preparation The standard operating procedure fails to include written descriptions of the methods for component preparation, including any time restrictions for specific steps in processing. Specifically, ***
156 21 CFR 606.160(c) 3 Assignment of donor number Failure of records describing the history and ultimate disposition of blood products to include a donor number [assigned to each accepted donor] [which relates to the unit of blood collected from that donor] [which relates to the donor's medical record] [which relates to any component or blood product from the donor's unit of blood]. Specifically, ***
158 21 CFR 606.160(e) 3 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, ***
206 21 CFR 640.3(a) 3 Donor suitability determined by unqualified person Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a person under his supervision and trained in determining suitability. Specifically, ***
207 21 CFR 640.3(a) 3 Donor suitability not performed on day of collection Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection. Specifically, ***
215 21 CFR 640.3(b)(6) 3 Qualifications of donor - disease transmissible by blood Failure to determine whether each donor is free from any disease transmissible by blood as determined by history and examinations. Specifically, ***
333 21 CFR 640.64(e) 3 Prevention of contamination The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, ***
9052 21 CFR 600.11(b) 3 Equipment There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use]. Specifically, ***
9240 21 CFR 630.6(d)(1) 3 Physician notification Failure to provide to an autologous donor's referring physician [information that the autologous donor is deferred based on the results of tests for evidence of infection due to communicable disease agents, and the reason for that decision] [the types of donation of blood and blood components that the autologous donor should not donate in the future] [the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral] [results of any supplemental tests]. Specifically, ***
43 21 CFR 606.40(a)(3) 2 Provide space for storage of blood & blood products Failure to provide adequate space for the storage of blood or blood components pending completion of tests. Specifically, ***
46 21 CFR 606.40(a)(6) 2 Provide space for quarantine of unsuitable for use items Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use. Specifically, ***
81 21 CFR 606.100(b)(2) 2 Donor qualifying tests & measurements The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining acceptability. Specifically, ***
82 21 CFR 606.100(b)(3) 2 Preparation of phlebotomy site The standard operating procedure fails to include written descriptions of solutions and methods used to prepare the site of phlebotomy to give maximum assurance of a sterile container of blood. Specifically, ***
117 21 CFR 606.121(f) 2 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, ***
162 21 CFR 606.165(a) 2 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, ***
211 21 CFR 640.3(b)(2) 2 Qualifications of donor - blood pressure Each donor was not in good health as indicated in part by systolic and diastolic blood pressures which were not within normal limits and the examining physician has not determined that this individual with blood pressures outside these limits is otherwise qualified as a donor. Specifically, ***
246 21 CFR 640.25(a) 2 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, ***
251 21 CFR 640.25(b) 2 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, ***
368 21 CFR 640.72(d) 2 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, ***
376 21 CFR 640.120 2 Alternative procedures Failure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components] [blood products]. Specifically, ***
3438 21 CFR 600.15 2 Temperatures during shipment Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 degree C or colder] [Cryoprecipitated AHF at -18 degree C or colder] [Liquid Plasma at 1 to 10 degree C] [Plasma at -18 degree C or colder] [Platelets as close as possible to a range between 20 to 24 degree C] [ Red Blood Cells and Whole Blood between 1 and 10 degree C] [Red Blood Cells, Frozen at -65 degree or colder] [Source Plasma at -5 degree C or colder] [Source Plasma Liquid at 10 degree C or colder]. Specifically, ***
3543 21 CFR 610.46(a)(1) 2 Quarantine and notification When a donor tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise was determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action within 72 hours to [institute a quarantine] [notify your consignee(s) for the purpose of instituting a quarantine] of [whole blood] [blood components] [source plasma] [source leukocytes] collected from the donor. Specifically, ***
9077 21 CFR 600.12(a) 2 Maintenance - completeness The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product]. Specifically, ***
9223 21 CFR 606.160(b)(6) 2 Required records - transfusion reaction and complaints Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up. Specifically, ***
9238 21 CFR 630.6(b)(3) 2 Results of testing Failure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral] [supplemental tests]. Specifically, ***
9264 21 CFR 610.40(d)(4) 2 Autologous donation - label Failure to label autologous donations with the [name of the donor] [identifying information of the donor] [appropriate caution statement]. Specifically, ***
9288 21 CFR 640.21 2 Suitability of donor All [plasmapheresis] [plateletpheresis] donors did not meet the criteria for suitability. Specifically, **
36 21 CFR 606.40 1 Suitable size, construction, etc. Failure to provide facilities of suitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper operations. Specifically, ***
45 21 CFR 606.40(a)(5) 1 Provide space for storage of finished product Failure to provide adequate space for the storage of finished products prior to distribution. Specifically, ***
63 21 CFR 606.65 1 Safe, sanitary, orderly storage Failure to store all supplies and reagents used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner. Specifically, ***
69 21 CFR 606.65(a) 1 Surfaces are sterile, pyrogen free, and non-reactive Failure to ensure that all surfaces coming in contact with blood and blood components intended for transfusion are [sterile] [pyrogen-free] [do not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the product]. Specifically, ***
86 21 CFR 606.100(b)(7) 1 Methods for performance of all tests The standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood components during processing. Specifically, ***
87 21 CFR 606.100(b)(8) 1 Methods for pre-transfusion testing The standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units. Specifically, ***
91 21 CFR 606.100(b)(12) 1 Criteria for suitability of reissue of returned blood The standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for reissue. Specifically, ***
92 21 CFR 606.100(b)(13) 1 Procedures to relate blood from donor to final disposition The standard operating procedure fails to include a written description of the procedures used for relating a unit of blood or blood component from the donor to its final disposition. Specifically, ***
95 21 CFR 606.100(b)(16) 1 Labeling procedures to avoid labeling mix-ups The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups]. Specifically, ***
108 21 CFR 606.120(c) 1 Legibility of labels Failure to utilize clear and legible labeling. Specifically, ***
111 21 CFR 606.120(b)(3) 1 Utilization of labeling checks Failure to utilize all necessary checks in labeling procedures to prevent errors in translating test results to container labels. Specifically, ***
121 21 CFR 606.121(c)(2) 1 Name, address, registration number The container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed product]. Specifically, ***
124 21 CFR 606.121(c)(5) 1 Paid or volunteer donor statement The container label of the blood product intended for transfusion fails to include the appropriate donor classification statement, i.e., "paid donor" or "volunteer donor." Specifically, ***
144 21 CFR 606.140(c) 1 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, ***
163 21 CFR 606.165(b) 1 Distribution records - content Distribution records fail to contain information to readily facilitate identification of [the name and address of the consignee] [the date and quantity delivered] [the lot number of the unit(s)] [the date of expiration or date of collection] [the name of the recipient for crossmatched blood and blood components]. Specifically, ***
205 21 CFR 640.3(f) 1 Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b). Specifically, ***
212 21 CFR 640.3(b)(3) 1 Qualifications of donor - hemoglobin Each donor was not in good health as indicated in part by the blood hemoglobin level which was demonstrated to be less than 12.5 gm. of hemoglobin per 100 ml of blood (38% by microhematocrit). Specifically, ***
221 21 CFR 640.4(c) 1 Blood containers and donor sets The [blood containers] [donor sets] are not [pyrogen-free] [sterile] [identified by lot number] [water repellent when used for processing Heparin Whole Blood]. Specifically, ***
238 21 CFR 640.11(a) 1 General requirements - storage Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, ***
241 21 CFR 640.11(b) 1 General requirements - inspection Failure to [inspect Red Blood Cells immediately after separation of the plasma, periodically during storage, and at the time of issue] [prevent issuance if Red Blood Cells are abnormal in color, physical appearance, or indicative of microbial contamination]. Specifically, ***
260 21 CFR 640.31(b) 1 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, ***
313 21 CFR 640.63(e) 1 Failure to return red blood cells Failure to defer each donor for eight weeks who has [not had the red blood cells returned from a unit of blood] [been a donor of a unit of whole blood]. Specifically, ***
321 21 CFR 640.63(c)(6) 1 Weight Donor did not weigh 110 pounds or more on the date of donation. Specifically, ***
329 21 CFR 640.64(a) 1 Supervision Failure to draw blood from a donor for the collection of Source Plasma by a physician or trained persons under his supervision trained in the procedure. Specifically, ***
366 21 CFR 640.72(b) 1 Cross reference of donor record to unit of plasma Failure to directly cross-reference each donor record to the unit(s) of the Source Plasma associated with the donor. Specifically, ***
3248 21 CFR 640.63(a) 1 Determining donor suitability Failure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision]. Specifically, ***
3252 21 CFR 640.63(a) 1 Determination not made on day of collection Determination of the suitability of Source Plasma donors was not made on the day of collection. Specifically, ***
3443 21 CFR 610.47 1 Notification of transfusion recipients Failure to [notify the attending physician of a recipient of a lookback unit] [make a minimum of three attempts within 8 weeks to notify the recipient of a lookback unit in the event the physician does not inform the recipient] [notify recipient's legal representative or relative] [document notifications of lookback units]. Specifically, ***
3451 21 CFR 601.22 1 Products in Short Supply Failure of manufacturer to establish that persons/places who conduct initial, and partial manufacturing of a product for shipment solely to such manufacturer are [registered with FDA] [in full compliance with the applicable regulations of this subchapter related to continued safety, purity and potency]. Specifically, ***
3452 21 CFR 601.12(b) 1 Major changes to an approved application Failure to [submit a supplement] [receive supplement approval from FDA] prior to distributing product made using the change. Specifically, ***
3498 21 CFR 640.91(c) 1 Microbial contamination Processing [step] [steps] not conducted in a manner to minimize the risk of contamination. Specifically, ***
3544 21 CFR 610.46(a)(2) 1 Quarantine by consignee When you were notified that a donor had tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise had been determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action to quarantine [whole blood] [blood components] [source plasma] [source leukocytes] collected from the donor. Specifically, ***
3618 21 CFR 606.100(b)(19) 1 Procedure for HIV lookback There is no written procedure to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to human immunodeficiency virus, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations. Specifically, ***
9006 21 CFR 606.100(b)(19) 1 Notification of attending physicians The written procedures for HIV "lookback" fail to include procedures in accordance with 21 CFR 610.47 to notify attending physicians so that transfusion recipients are informed that they may have received [Whole Blood] [blood components] at increased risk for transmitting HIV. Specifically, ***
9051 21 CFR 600.11(a) 1 Work areas - temperatures The [refrigerators] [incubators] [temperature controlled rooms] [are not maintained at the required temperatures] [are not free of extraneous material that may affect the safety of the product]. Specifically, ***
9097 21 CFR 600.15 1 Blood & Blood Components Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 °C or colder] [Cryoprecipitated AHF at -18 °C or colder] [Liquid Plasma at 1 to 10 °C] [Plasma at -18 °C or colder] [Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the labeled range] [Red Blood Cells between 1 and 10 °C] [Red Blood Cells, Frozen at -65 °C or colder] [Source Plasma at -5 °C or colder] [Source Plasma Liquid at 10 °C or colder] [Whole Blood as required]. Specifically, ***
9235 21 CFR 630.6(c) 1 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, ***
9236 21 CFR 630.6(b)(1) 1 Deferred or not suitable Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral]. Specifically, ***
9256 21 CFR 610.41 1 Donor Deferral Failure to defer a donor who tested reactive [by a screening test for evidence of infection due to a communicable disease agent] [for a serological test for syphilis] from further donations of human blood and blood components. Specifically, ***
9262 21 CFR 610.40(b) 1 Approved screening tests Blood or blood components were not tested for evidence of infection due to communicable disease agents [using screening tests that the FDA has approved for such use][in accordance with the manufacturer's instructions]. Specifically, ***
9271 21 CFR 610.41 1 Donor Deferral - reentry The method or process used to requalify deferred donors was not found acceptable for such purposes by FDA. Specifically, ***
9275 21 CFR 640.4(g)(5) 1 Anticoagulant All segments for compatibility testing did not contain blood mixed with appropriate anticoagulant. Specifically, ***
9285 21 CFR 640.16(a) 1 Separation Failure to prepare Red Blood Cells [in the time frame specified in the directions for use for the system used] [by centrifugation, in a manner that will not tend to increase the temperature of the blood]. Specifically, ***

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Parts 1240 and 1250

Center Name Cite Id Ref No Frequency Short Description Long Description
Parts 1240 and 1250 7036 21 CFR 1250.67 64 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, ***
7032 21 CFR 1250.63 45 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, ***
6569 21 CFR 1250.33(b) 37 Equipment kept clean Failure to keep all equipment clean. Specifically, ***
6560 21 CFR 1250.32(a) 36 Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***
6552 21 CFR 1250.28 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, ***
6570 21 CFR 1250.33(c) 27 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, ***
6558 21 CFR 1250.30(d) 25 Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***
6564 21 CFR 1250.33(a) 23 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, ***
6581 21 CFR 1250.38(b) 21 Soap, sanitary towels, water Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, ***
6580 21 CFR 1250.38(b) 19 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, ***
6591 21 CFR 1250.42(a) 19 Backflow protection A water system not protected against backflow. Specifically, ***
6572 21 CFR 1250.34 16 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, ***
6579 21 CFR 1250.38(a) 16 Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***
6555 21 CFR 1250.30(a) 9 Clean and free from flies, rodents, and other vermin Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin]. Specifically, ***
7055 21 CFR 1250.75(b) 8 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, ***
6565 21 CFR 1250.33(a) 7 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, ***
6567 21 CFR 1250.33(b) 7 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, ***
7051 21 CFR 1250.75(a) 7 Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, ***
6525 21 CFR 1240.86 6 Lack of backflow prevention A connection exists between a nonpotable water system on [a vessel] [your vessel] and a potable water system on [a] [your] pier; there are no provisions to prevent backflow from the vessel to the pier.
6554 21 CFR 1250.30(a) 6 Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, ***
6593 21 CFR 1250.42(b) 6 Connections easily cleanable, located and protected Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply. Specifically, ***
7053 21 CFR 1250.75(b) 6 Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***
7090 21 CFR 1250.82(e) 5 Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, ***
6549 21 CFR 1250.27 4 Storage of perishables Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving. Specifically, ***
6609 21 CFR 1250.49 4 Clean and free of flies and mosquitoes Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit. Specifically, ***
7039 21 CFR 1250.67 4 Bulk ice Equipment used to [store] [wash] [handle] [deliver] bulk ice intended for [the cooling of drinking water or other beverages] [food preservation purposes] is not [constructed so as not to become a factor in the transmission of communicable diseases] [used for no other purposes]. Specifically, ***
6561 21 CFR 1250.32(b) 3 Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, ***
6563 21 CFR 1250.33(a) 3 Easily cleaned, self-draining Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are constructed so as to be [easily cleaned] [self-draining]. Specifically, ***
6582 21 CFR 1250.38(b) 3 Maintained in clean condition Failure to maintain toilet rooms in a clean condition. Specifically, ***
6586 21 CFR 1250.39 3 Frequency of disposition Failure to dispose of [garbage] [refuse] as frequently as necessary and practicable. Specifically, ***
7041 21 CFR 1250.70(a) 3 Adequate and readily accessible Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained] [cleaned]. Specifically, ***
7056 21 CFR 1250.75(c) 3 Persons handling soil cans and other containers Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected with the [loading] [unloading] [transporting] [handling] of [food] [water] [ice]. Specifically, ***
7089 21 CFR 1250.82(d) 3 Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification. Specifically, ***
6585 21 CFR 1250.39 2 Containers - close-fitting covers Garbage containers lack close-fitting covers. Specifically, ***
7118 21 CFR 1250.90 2 Clean condition Toilet and lavatory [equipment] [spaces] not maintained in a clean condition. Specifically, ***
6503 21 CFR 1240.60(a) 1 Handled or stored in an insanitary manner Molluscan shellfish have been [handled] [stored] in such an insanitary manner that [they are likely to become agents in] [their transportation is likely to contribute to] the spread of communicable disease. Specifically, ***
6505 21 CFR 1240.60(b) 1 Lack of tag on shellstock Shellstock fails to bear a tag that discloses [the date and place they were harvested (by State and site)] [type and quantity of shellfish] [by whom they were harvested]. Specifically, ***
6509 21 CFR 1240.61(b) 1 Inadequate pasteurization Pasteurization of [milk] [milk products] does not meet minimum time-temperature requirements. Specifically, ***
6531 21 CFR 1250.22 1 Clean, wholesome, free from spoilage Not all [food] [drink] served onboard is [clean] [wholesome] [free from spoilage]. Specifically, ***
6557 21 CFR 1250.30(c) 1 Water supply Water [of satisfactory sanitary quality] [under head of pressure] [adequate in amount and temperature] is not easily accessible to all rooms in which [food is prepared] [utensils are cleaned]. Specifically, ***
6568 21 CFR 1250.33(b) 1 Cleaning of all other utensils Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the day's operation. Specifically, ***
6573 21 CFR 1250.34 1 Backflow protection for waste water drains Waste water drains from [ice boxes] [refrigerating equipment] [refrigerated spaces] are not so installed as to prevent backflow of contaminating liquids. Specifically, ***
6584 21 CFR 1250.39 1 Containers - watertight, readily cleanable, non-absorbent Garbage containers are not [watertight] [readily cleanable] [non-absorbent]. Specifically, ***
6588 21 CFR 1250.41 1 Submittal of construction plans Failure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review. Specifically, ***
6590 21 CFR 1250.42(a) 1 Complete and closed A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically, ***
6596 21 CFR 1250.42(d) 1 Water filters Failure to [operate] [maintain] water filters so as to prevent contamination of the water. Specifically, ***
6612 21 CFR 1250.50 1 Designed to permit ready cleaning Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***
7038 21 CFR 1250.67 1 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, ***
7054 21 CFR 1250.75(b) 1 Soil cans and removable containers Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use. Specifically, ***
7058 21 CFR 1250.79(a) 1 Container construction Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent] [equipped with close-fitting covers]. Specifically, ***
7121 21 CFR 1250.96 1 Rodent infestation Failure to prevent, through generally accepted methods of control, an infestation by rodents.Specifically, ***

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Human tissue for transplantation

Center Name Cite Id Ref No Frequency Short Description Long Description
Human tissue for transplantation 12221 21 CFR 1271.47(a) 18 Procedures for all steps Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].Specifically, ***
12336 21 CFR 1271.180(a) 16 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, ***
12311 21 CFR 1271.160(b)(1) 10 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, ***
12277 21 CFR 1271.75(a)(1) 9 Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for [risk factors][clinical evidence] of communicable disease agents and diseases. Specifically, ***
12326 21 CFR 1271.160(c) 9 Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed.Specifically, ***
12369 21 CFR 1271.200(b) 9 Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].Specifically, ***
12411 21 CFR 1271.260(a) 8 Contamination, mix ups, improper release Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made available for distribution].Specifically, ***
12437 21 CFR 1271.270(a) 8 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, ***
15020 21 CFR 1271.200(e) 8 Documentation of maintenance and cleaning Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.Specifically, ***
12283 21 CFR 1271.75(e) 6 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, ***
12287 21 CFR 1271.80(c) 6 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, ***
12310 21 CFR 1271.160(a) 6 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, ***
12322 21 CFR 1271.160(b)(4) 6 Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities. Specifically, ***
12324 21 CFR 1271.160(b)(6) 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, ***
12334 21 CFR 1271.170(c) 6 Trained or re-trained as necessary Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities. Specifically, ***
12416 21 CFR 1271.260(e) 6 Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
12431 21 CFR 1271.265(e) 6 Procedures and release criteria Procedures includingrelease criteria for activities relating to the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised].Specifically, ***
12435 21 CFR 1271.270(a) 6 Records maintained concurrently Records were not maintained concurrently with the performance of each step.Specifically, ***
12436 21 CFR 1271.270(a) 6 Accurate, indelible, legible Records were not [accurate] [indelible] [legible]. Specifically, ***
12286 21 CFR 1271.80(b) 5 Specimen collections not timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time. Specifically, ***
12301 21 CFR 1271.150(c)(1)(iii) 5 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, ***
12323 21 CFR 1271.160(b)(5) 5 Monitoring systems The quality program has not established and maintained appropriate monitoring systems.Specifically, ***
12363 21 CFR 1271.195(c) 5 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, ***
12381 21 CFR 1271.210(d)(2) 5 Verification elements Documentation of the verification of [supplies] [reagents] did not include [test results] [a certificate of analysis from the vendor]. Specifically, ***
3736 21 CFR 1270.31(b) 4 Assessment of relevant medical records Failure to [prepare] [follow] written procedures for all significant steps for [obtaining] [reviewing] [assessing] the relevant medical records of a donor.Specifically, ***
12213 21 CFR 1271.47(a) 4 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, ***
12237 21 CFR 1271.55(a)(3) 4 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, ***
12238 21 CFR 1271.55(b)(1) 4 Statement re: certified testing lab The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services. Specifically, ***
12332 21 CFR 1271.170(b) 4 Qualifications lacking Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions. Specifically, ***
12365 21 CFR 1271.195(d) 4 Documentation not maintained Documentation of environmental control and monitoring activities was not maintained.Specifically, ***
12372 21 CFR 1271.200(c) 4 Calibrated per established schedules Equipment used for [inspection] [measuring] [testing] was not calibratedaccording to established schedules.Specifically, ***
12375 21 CFR 1271.210(a) 4 Use prior to verification Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease.Specifically, ***
12417 21 CFR 1271.260(e) 4 Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits. Specifically, ***
12428 21 CFR 1271.265(c)(3) 4 Departures: recorded and justified Departures from procedures were not [recorded] [justified] at the time of occurrence.Specifically, ***
12447 21 CFR 1271.290(b) 4 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, ****
12453 21 CFR 1271.290(e) 4 Documenting disposition of each HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if any]. Specifically, ***
12223 21 CFR 1271.47(b) 3 Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
12224 21 CFR 1271.47(c) 3 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, ***
12229 21 CFR 1271.50(a) 3 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, ***
12230 21 CFR 1271.50(a) 3 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, ***
12288 21 CFR 1271.80(c) 3 Manufacturer instructions not followed Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions. Specifically, ***
12309 21 CFR 1271.160(a) 3 Program is appropriate for the HCT/Ps A quality program appropriate for the HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
12319 21 CFR 1271.160(b)(3) 3 Actions taken and documented The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented]. Specifically, ***
12320 21 CFR 1271.160(b)(3) 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, ***
12325 21 CFR 1271.160(b)(6) 3 Deviations--evaluation, cause, corrective action Investigation of deviations related to core CGTP requirements did not include [a review and evaluation of the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the deviation and prevent recurrence]. Specifically, ***
12343 21 CFR 1271.190(a) 3 State of repair Facilities were not maintained in a good state of repair. Specifically, ***
12351 21 CFR 1271.190(d)(1) 3 Procedures for cleaning, sanitation Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].Specifically, ***
12354 21 CFR 1271.190(d)(2) 3 Documentation of activities Documentation of facility cleaning and sanitation activities was not maintained.Specifically, ***
12371 21 CFR 1271.200(a) 3 Cleaned, sanitized per established schedules Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]according to established schedules.Specifically, ***
12377 21 CFR 1271.210(c) 3 In-house reagent production The processes used for the production of in-house reagents were not [validated] [verified].Specifically, ***
12382 21 CFR 1271.210(d)(3) 3 Lot documentation maintained Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained. Specifically, ***
12389 21 CFR 1271.220(c) 3 Specified requirements for in-process controls Specified requirements for in-process controls were not met. Specifically, ***
12408 21 CFR 1271.250(c) 3 All labeling requirements met Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements. Specifically, ***
12421 21 CFR 1271.265(a) 3 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, ***
12494 21 CFR 1271.85(c) 3 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, ***
3724 21 CFR 1270.21(f) 2 Donor identity, relevant records The determination by a responsible person that the human tissue was suitable for transplantation did not include [donor identity] [relevant medical records as defined in 21 CFR 1270.3(t)]. Specifically, ***
12222 21 CFR 1271.47(a) 2 Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.Specifically, ***
12225 21 CFR 1271.47(d) 2 Departures: recording and justifying Departures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified]. Specifically, ***
12240 21 CFR 1271.55(b)(3) 2 Name and address on summary The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination. Specifically, ***
12281 21 CFR 1271.75(c) 2 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, ***
12290 21 CFR 1271.80(d)(1) 2 Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible. Specifically, ***
12314 21 CFR 1217.160(b)(2)(iii) 2 Risk assessment, quarantine, recall, FDA The quality program has not ensured that procedures include provisions for [assessing the risk of] [quarantine of] [recall of] [reporting to FDA on] HCT/Ps that have been made available for distribution and for which there is information related to the possible contamination or communicable disease transmission.Specifically, ***
12315 21 CFR 1271.160(b)(2) 2 Sharing of information (general) The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or communicable disease transmission of HCT/Ps.Specifically, ***
12316 21 CFR 1271.160(b)(2)(i) 2 Other establishments - same donor involved The quality program has not ensured that procedures exist for sharing information pertaining to the possible contamination of the HCT/P, or the potential for transmission of a communicable disease by the HCT/P, with other establishments that are known to have recovered HCT/Ps from the same donor. Specifically, ***
12328 21 CFR 1271.160(d) 2 Validation for intended use The performance of [custom computer software] [commercial computer software that has been customized or programmed], including changes to computer software, has not been validated for the intended use, when such software is relied upon to comply with core GTP requirements. Specifically, ***
12331 21 CFR 1271.170(a) 2 Sufficient number Personnel are not sufficient to ensure compliance with the requirements.Specifically, ***
12337 21 CFR 1271.180(a) 2 Design adequate to bar spread of CD's Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and spread through the use of HCT/Ps.Specifically, ***
12338 21 CFR 1271.180(b) 2 Review and approval-responsible person Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***
12339 21 CFR 1271.180(c) 2 Availability of procedures Procedures for core CTGP requirements were not available to personnel in the area where operations are performed, or in a nearby area when such availability is impractical. Specifically, ***
12356 21 CFR 1271.195(a) 2 Adequate control, proper conditions Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for operations were not provided].Specifically, ***
12358 21 CFR 1271.195(a)(2) 2 Ventilation and air filtration controls Environmental controls do not provide for adequate [ventilation] [air filtration].Specifically, ***
12359 21 CFR 1271.195(a)(3) 2 Aseptic processing---cleaning, disinfecting Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing. Specifically, ***
12398 21 CFR 1271.230(a) 2 Validation & approval--established procedures Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures.Specifically, ***
12399 21 CFR 1271.230(a) 2 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, ***
12414 21 CFR 1271.260(d) 2 Corrective actions Corrective actions were not [performed] [documented] when proper storage conditions were not met.Specifically, ***
12415 21 CFR 1271.260(e) 2 Temperature limits Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents.Specifically, ***
12423 21 CFR 1271.265(b) 2 Shipment in quarantine of HCT/Ps HCT/Ps shipped as pre-distribution shipments [within your establishment] [between establishments] which do not meet the criteria for being available for distribution were not shipped in quarantine. Specifically, ***
12429 21 CFR 1271.265(d) 2 Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.Specifically, ***
12433 21 CFR 1271.265(f) 2 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, ***
12438 21 CFR 1271.270(b) 2 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, ***
12479 21 CFR 1271.370(b)(4) 2 Warnings on label HCT/Ps made available for distribution were not labeled with or accompanied by applicable warnings. Specifically, ***
12492 21 CFR 1271.85(a) 2 Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents.Specifically, ***
12493 21 CFR 1271.90(b) 2 Eligibility not required--warning labels HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements. Specifically, ***
3722 21 CFR 1270.21(e) 1 Accompanying donor records Human tissue intended for transplantation was not accompanied by a summary or copies of the donor's relevant medical records as defined in 21 CFR 1270.3(t).Specifically, ***
3723 21 CFR 1270.21(e) 1 Person responsible The summary or copies of the donor's relevant medical records as defined in 21 CFR 1270.3(t) failed to designate and identify the person responsible for making the determination that the human tissue was suitable for transplantation.Specifically, ***
3740 21 CFR 1270.31(d) 1 Prevention of cross-contamination Failure to [prepare] [validate] [follow] written procedures for prevention of [infectious disease contamination] [cross-contamination] during processing.Specifically, ***
3744 21 CFR 1270.33(a) 1 Accurate, indelible, legible Failure to maintain records which are [accurate] [indelible] [legible]. Specifically, ***
3745 21 CFR 1270.33(a) 1 Person involved, dates, details Records fail to [identify the person performing the work] [include the dates of the various entries] [be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved].Specifically, ***
3749 21 CFR 1270.33(d) 1 Determination of suitability Failure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records documenting that the tissue has been so determined. Specifically, ***
3750 21 CFR 1270.33(d) 1 Completion and review of testing & screening Failure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records documenting that all infectious testing and screening have been [completed] [reviewed] [found to be negative].Specifically, ***
3751 21 CFR 1270.33(e) 1 Quarantine until release or disposition Failure to quarantine tissue until [it has been determined to be suitable for transplantation] [appropriate disposition has been accomplished].Specifically, ***
3752 21 CFR 1270.33(f) 1 Make available to FDA Failure to make available for inspection or upon request by FDA, records regarding donor suitability, including all testing and screening records. Specifically, ***
3754 21 CFR 1270.33(h) 1 Retention for 10 years Failure to retain records regarding donor suitability for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is latest. Specifically, ***
3758 21 CFR 1270.35(c) 1 Receipt and/or distribution Records fail to include documentation of receipt and/or distribution of human tissue.Specifically, ***
12226 21 CFR 1271.47(d) 1 Determining risks when departures involved A determination that departures from donor eligibility procedures did not increase the risk of communicable disease transmission was not made by a responsible person prior to making an HCT/P available for distribution.Specifically, ***
12227 21 CFR 1271.47(e) 1 Adopting procedures from another organization Current donor eligibility procedures adopted from another organization were not verified to be [consistent with the donor eligibility requirements specified in the regulations] [appropriate for your operations].Specifically, ***
12236 21 CFR 1271.55(a)(2) 1 Eligibility statement--basis of determination After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing. Specifically, ***
12239 21 CFR 1271.55(b)(2) 1 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, ***
12242 21 CFR 1271.55(c) 1 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, ***
12245 21 CFR 1271.55(d)(1)(ii) 1 Results, interpretation of CD screening Documentation of [the results] [the interpretation] of all donor screening for communicable diseases was not maintained. Specifically, *
12246 21 CFR 1271.55(d)(1)(iii) 1 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, ***
12249 21 CFR 1271.55(d)(3) 1 Records not made available to FDA Required donor eligibility records were not made available for authorized inspection or upon request by FDA. Specifically, ***
12254 21 CFR 1271.60(b) 1 Identified as quarantined, distinguishable HCT/Ps in quarantinepending completion of the donor eligibility determination were [not clearly identified as quarantined] [not easily distinguishable from HCT/Ps available for release and distribution].Specifically, ***
12258 21 CFR 1271.60(c)(3) 1 Statement of restrictions HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the product must not be implanted, transplanted, infused or transferred until completion of the donor-eligibility determination. Specifically, ***
12264 21 CFR 1271.60(d)(2)(ii) 1 Results of completed donor testing HCT/Ps made available for use in cases of urgent medical need were not accompanied by the results of any donor testing that has been completed. Specifically, ***
12267 21 CFR 1271.60(d)(4) 1 Eligibility determination not completed The donor-eligibility determination was not completed for HCT/Ps used in cases of urgent medical need. Specifically, ***
12275 21 CFR 1271.65(c) 1 Nonclinical use--label requirements HCT/Ps from ineligible donors which were made available for nonclinical use were not labeled ["For Nonclinical Use Only"] [with the Biohazard legend].Specifically, ***
12278 21 CFR 1271.75(a)(2) 1 Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation. Specifically, ***
12312 21 CFR 1271.160(b)(2) 1 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.
12321 21 CFR 1271.160(b)(3) 1 Problem description, disposition, date et. al. Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the nature of the problem] [the description of the corrective action] [the date of the corrective action]. Specifically, ***
12329 21 CFR 1271.160(d) 1 Documentation/approval prior to implementation Computer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation. Specifically, ***
12333 21 CFR 1271.170(b) 1 Not qualified, authorized for functions Personnel perform functions for which they are not [qualified] [authorized].Specifically, ***
12340 21 CFR 1271.180(d) 1 Adopted from another organization Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations]. Specifically, ***
12342 21 CFR 1271.190(a) 1 Size, construction, location--prevent mix-ups etc. Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups]. Specifically, ***
12345 21 CFR 1271.190(b)(1) 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, ***
12349 21 CFR 1271.190(c) 1 Control system Operations were not controlled with a system [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] to prevent [improper labeling] [mix-ups] [contamination] [cross contamination] [accidental exposure of HCT/Ps to communicable disease agents]. Specifically, ***
12362 21 CFR 1271.195(b) 1 Corrective actions Appropriate corrective actions were not taken related to the inspections of environmental control systems. Specifically, ***
12367 21 CFR 1271.200(a) 1 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, ***
12370 21 CFR 1271.200(c) 1 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, ***
12373 21 CFR 1271.200(d) 1 Inspected routinely Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules]. Specifically, ***
12378 21 CFR 1271.210(d)(1) 1 Receipt documentation maintained Documentation of the receipt of [supplies] [reagents] was not maintained.Specifically, ***
12379 21 CFR 1271.210(d)(1) 1 Receipt documentation elements The documentation for the receipt of [supplies] [reagents] did not include [the type] [the quantity] [the manufacturer] [the lot number] [the date of receipt] [the expiration date]. Specifically, ***
12380 21 CFR 1271.210(d)(2) 1 Verification documentation maintained Documentation of the verification of [supplies] [reagents] was not maintained.Specifically, ***
12384 21 CFR 1271.215 1 Potential problems with recovery HCT/Ps were not recovered in a way [that does not cause contamination or cross contamination during recovery] [that does not increase the risk of introduction, transmission or spread of communicable disease]. Specifically, ***
12396 21 CFR 1271.225 1 Approval and timely communication Process changes were [not approved by a responsible person with appropriate knowledge and background prior to implementation] [not communicated to personnel in a timely manner]. Specifically, ***
12400 21 CFR 1271.230(a) 1 Documented, dated, signed The validation [activities] [results] were not [documented] [dated and signed by the individual(s) approving the validation]. Specifically, ***
12401 21 CFR 1271.230(b) 1 Reduced risk representation Written representation that processing methods reduce the risk of transmission of communicable disease by HCT/Ps was not based on a fully validated or verified process.Specifically, ***
12407 21 CFR 1271.250(b) 1 Verification of label accuracy, legibility, integrity Labeling procedures did not include verification of label [accuracy] [legibility] [integrity].Specifically, ***
12409 21 CFR 1271.250(c) 1 Documentation of donor eligibility Labeling procedures did not ensure that HCT/Ps made available for distribution are accompanied by documentation of the donor eligibility determination.Specifically, ***
12412 21 CFR 1271.260(b) 1 Storage temperatures appropriate HCT/Ps were not stored at appropriate temperatures. Specifically, ***
12413 21 CFR 1271.260(c) 1 Expiration date factors HCT/Ps were not assigned an expiration date based on [type of HCT/P] [processing, including method of preservation] [storage conditions] [packaging].Specifically, ***
12419 21 CFR 1271.265(a) 1 Evaluation--microorganisms, damage Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination]. Specifically, ***
12425 21 CFR 1271.265(c)(1) 1 Release of HCT/Ps by responsible person Aresponsible person did not [document] [date] the determination that an HCT/P is available for distribution.Specifically, ***
12427 21 CFR 1271.265(c)(3) 1 HCT/Ps made under departure from process A responsible person did not determine that HCT/Ps manufactured under a departure from procedures do not increase the risk of communicable disease prior to making the HCT/Ps available for distribution. Specifically, ***
12432 21 CFR 1271.265(e) 1 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, ***
12443 21 CFR 1271.270(d) 1 Retention time (10 year rules) Records were not retained for the appropriate length of time, [10 years after their creation] [at least 10 years after the date of administration of a particular HCT/P] [at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of administration is not known] [10 years after the appropriate disposition of archived specimens of dura mater].Specifically, ***
12457 21 CFR 1271.320(a) 1 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, ***
12463 21 CFR 1271.320(c) 1 Documentation of decision not to investigate When no investigation of a complaint was made for an event that is not required to be reported to FDA, a record of [the reason no investigation was made] [the individual responsible for making that decision] was not maintained. Specifically, ***
12470 21 CFR 1271.350(a)(2) 1 15 day reporting timeframe Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information. Specifically, ***
12472 21 CFR 1271.350(b)(1) 1 Deviations not investigated HCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated. Specifically, ***
12473 21 CFR 1271.350(b)(2) 1 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, ***
12489 21 CFR 1271.90(b)(1) 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, ***
12496 21 CFR 1271.85(b)(2) 1 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. ***
15023 21 CFR 1271.270(b) 1 Management system, other records Records pertinent to the manufacture of HCT/Ps were not maintained and organized under the records management system. Specifically, ***
15025 21 CFR 1271.85(b)(2) 1 Cytomegalovirus (CMV) Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to cytomegalovirus (CMV). Specifically, ***

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Radiological health

Center Name Cite Id Ref No Frequency Short Description Long Description
Radiological health 5007 21 CFR 1002.13 2 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, ***
5032 21 CFR 1010.2(b) 1 Certification label or tag A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible] [readily accessible to view when the product is fully assembled for use]. Specifically, ***
5700 21 CFR 1002.10 1 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, ***

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Page Last Updated: 04/23/2015
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