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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FY 2010 Inspectional Observation Summaries

 

Number of 483s issued from the System* 

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

Center Name 483s issued
Foods 2976
Devices 976
Drugs 746
Incidental text 362
Bioresearch monitoring 343
Biologics 275
Veterinary medicine 275
Parts 1240 and 1250 176
Human tissue for transplantation 133
Radiological health 24
Special requirements 17
Sum Product Area 483s from System* 6303
Actual Total in system 483s** 5710

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

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

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Foods

Center Name Cite Id Ref No Frequency Short Description Long Description
Foods 1560 21 CFR 110.35(c) 529 Lack of effective pest exclusion Effective measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the premises by pests].  Specifically, ***
1524 21 CFR 123.11(b) 421 Sanitation monitoring You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests].  Specifically, ***
905 21 CFR 123.6(b) 327 HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, ***
1306 21 CFR 110.20(b)(7) 315 Screening Failure to provide adequate screening or other protection against pests.  Specifically, ***
1422 21 CFR 110.20(b)(4) 307 Floors, walls and ceilings The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good repair]. Specifically, ***
1552 21 CFR 110.35(a) 282 Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, ***
1287 21 CFR 110.20(a)(1) 262 Harborage areas Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.  Specifically, ***
1553 21 CFR 110.35(a) 256 Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated.  Specifically, ***
1525 21 CFR 123.11(c) 206 Sanitation Records You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation deficiencies] for [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests].  Specifically, ***
990 21 CFR 110.10(b)(3) 194 Not washed/sanitized when appropriate Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before starting work] [after each absence from the work station] [at any time their hands may have become soiled or contaminated].  Specifically, ***
1554 21 CFR 110.35(a) 193 Cleaning and sanitizing operations Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
1695 21 CFR 110.80(b)(2) 191 Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].  Specifically, ***
1701 21 CFR 110.80(b)(7) 189 Equipment, containers, utensils Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination.  Specifically, ***
6004 21 CFR 123.6(c)(4) 186 Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit.  Specifically***
904 21 CFR 123.6(b) 181 No HACCP plan You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.  Specifically, ***
1405 21 CFR 110.10(b)(6) 178 Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.  Specifically, ***
1007 21 CFR 110.10(b)(9) 174 Precautions against contamination--micro, foreign substances Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances].  Specifically, ***
1427 21 CFR 110.20(b)(5) 174 Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food.  Specifically, ***
959 21 CFR 123.6(c)(1) 170 Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.  Specifically, ***
2386 21 CFR 110.80(a)(1) 167 Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, ***
908 21 CFR 123.6(d) 165 Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually].  Specifically, ***
960 21 CFR 123.6(c)(2) 164 Critical control points Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.  Specifically, ***
1424 21 CFR 110.20(b)(4) 163 Drip and condensate The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
961 21 CFR 123.6(c)(3) 155 Critical limits Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical limit that does not ensure control of one or more hazards].  Specifically,
963 21 CFR 123.6(c)(5) 154 Corrective action plan Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].  Specifically***
1689 21 CFR 110.80 153 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
1556 21 CFR 110.35(b)(2) 152 Storage requirements Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide chemicals] in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
1562 21 CFR 110.35(d) 142 Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food.  Specifically, ***
2392 21 CFR 110.80(b)(1) 135 Maintenance of equip., utensils, and finished food packaging Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing.  Specifically, ***
6008 21 CFR 123.8(a)(3) 131 Verification - record review - frequency You did not review [some of] your [critical control point monitoring][corrective action][calibration][in-process testing][end-product testing] records [within one week][within a reasonable time] after the records were made. Specifically, ***
1581 21 CFR 110.37(e) 128 Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature.  Specifically, ***
1615 21 CFR 110.93 124 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination.  Specifically, ***
1292 21 CFR 110.20(b)(1) 121 Sufficient space Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for the maintenance of sanitary operations and the production of safe food.  Specifically, ***
1597 21 CFR 110.37(b)(3) 116 As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  Specifically, ***
1005 21 CFR 110.10(b)(7) 112 Storage of personal items Personal [clothing] [belongings] were stored  in an area where [food is exposed] [equipment or utensils are washed].  Specifically, ***
1125 21 CFR 110.40(a) 112 Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, ***
945 21 CFR 123.12(a)(2) 110 Importer verification You do not have or have not implemented [written verification procedures] [product specifications] [an affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with the Seafood HACCP regulation.  Specifically, ***
6001 21 CFR 123.11(b) 109 Sanitation monitoring documentation Your sanitation control records do not accurately document the conditions or practices observed at your firm.  Specifically***
6020 21 CFR 123.9(a) 103 Records - content Your records do not include the [name and location of the processor or importer] [date and time of the activity the record reflects] [signature or initials of the person performing the operation] [identity of the product and the production code, if any].  Specifically, ***
3661 21 CFR 110.37(e)(5) 94 Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, ***
1006 21 CFR 110.10(b)(8) 93 Personal food/drink/tobacco Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in areas where [food is exposed] [equipment or utensils are washed].  Specifically, ***
3659 21 CFR 110.37(e)(3) 93 Hand drying Lack of a sanitary towel service or suitable hand drying devices.  Specifically, ***
1066 21 CFR 110.40(b) 92 Seams on food contact surfaces Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of microorganisms.  Specifically, ***
1126 21 CFR 110.40(a) 88 Precluding contaminants The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants].  Specifically, ***
1565 21 CFR 110.35(d)(3) 88 Non-food-contact surfaces (S) Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination.  Specifically, ***
933 21 CFR 123.8(a)(2)(ii) 87 Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, ***
985 21 CFR 110.10(b)(1) 86 Suitable outer garments Suitable outer garments are not worn  that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
6021 21 CFR 123.10 85 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.  Specifically, ***
3652 21 CFR 110.37(e)(1) 83 Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.  Specifically, ***
1402 21 CFR 110.10(b)(4) 82 Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers].  Specifically, ***
3658 21 CFR 110.37(e)(2) 80 Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, ***
1698 21 CFR 110.80(b)(5) 77 Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, ***
1429 21 CFR 110.20(b)(6) 76 Fans/air blowing equipment Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential for contaminating [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
12720 21 CFR 1.225 76 Not registered Your food facility is not registered as required.  Specifically, ***
1172 21 CFR 110.40(e) 71 Lack of thermometer Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.  Specifically, ***
6005 21 CFR 123.6(c)(6) 71 Verification procedures - adequacy Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.  Specifically, ***
1173 21 CFR 110.40(f) 69 Q.C. instrument accuracy, maintenance Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not [accurate] [adequately maintained].  Specifically,***
1571 21 CFR 110.35(d)(5) 67 Shown to be effective The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment].  Specifically, ***
1599 21 CFR 110.37(b)(5) 60 Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, ***
1406 21 CFR 110.10(b)(6) 59 Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner.  Specifically, ***
901 21 CFR 123.6(a) 58 Hazard analysis You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process. Specifically, ***
3643 21 CFR 110.10(b)(5) 58 Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.  Specifically, ***
1426 21 CFR 110.20(b)(5) 57 Adequate lighting Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms] [areas where food is examined, stored, or processed] [areas where equipment and utensils are cleaned].  Specifically, ***
1578 21 CFR 110.37(f) 57 Odor, attractant for pests, harborage The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor] [potential for waste becoming an attractant and harborage or breeding place for pests].  Specifically, ***
6018 21 CFR 123.7(a) 57 Corrective action per predetermined plan You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected].  Specifically,***
1598 21 CFR 110.37(b)(4) 56 Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage.  Specifically, ***
9931 21 CFR 120.6(b) 55 Sanitation monitoring You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good manufacturing practice including [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, *** 
906 21 CFR 123.6(b) 54 HACCP plan location Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed].  Specifically, ***
1067 21 CFR 110.40(c) 54 Non food-contact equipment in processing area Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition.  Specifically, ***
1293 21 CFR 110.20(b)(2) 54 Contamination with microorganisms, chemicals, filth, etc. Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from contamination with [microorganisms] [chemicals] [filth] [extraneous material] cannot be taken because of deficiencies in plant [size] [construction] [design].  Specifically, ***
6007 21 CFR 123.9(a) 54 Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed.  Specifically, ***
1702 21 CFR 110.80(b)(8) 51 Metal / extraneous materials Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food.  Specifically, ***
4470 21 CFR 108.25(c)(2) 51 Process filing Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, ***
1602 21 CFR 110.37(a) 49 Suitable temp. and pressure Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of food] [cleaning of equipment, utensils and food-packaging materials] [employee sanitary facilities].  Specifically, ***
1596 21 CFR 110.37(b)(2) 46 Convey sewage Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant.  Specifically, ***
1696 21 CFR 110.80(b)(3) 46 Holding foods - refrigerate/freeze/heat Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.  Specifically, ***
1709 21 CFR 110.80(b)(13) 46 Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated.  Specifically, ***
3656 21 CFR 110.37(d)(3) 46 Self-closing doors Toilet facilities lack self-closing doors.  Specifically, ***
1570 21 CFR 110.35(d)(5) 45 Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, ***
3654 21 CFR 110.37(d)(1) 45 Maintained Failure to maintain toilet facilities in a sanitary condition.  Specifically, ***
2388 21 CFR 110.80(a)(5) 43 Holding in bulk or suitable containers Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination.  Specifically, ***
913 21 CFR 123.8(a)(1) 41 Reassessment of HACCP plan Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least annually] [whenever modifications to the process are made].  Specifically, ***
1289 21 CFR 110.20(a)(3) 41 Drainage Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place for pests]. Specifically, ***
6015 21 CFR 123.6(c)(6) 41 Verification procedures - none/frequency  Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented.  Specifically, ***
931 21 CFR 123.8(d) 40 Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
1128 21 CFR 110.40(a) 38 Installation and maintenance of equipment (S) Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces].  Specifically, ***
6006 21 CFR 123.6(c)(7) 38 Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring.  Specifically, ***
1763 21 CFR 110.35(b)(1) 36 Safe and adequate for use Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the conditions of use].  Specifically, ***
6010 21 CFR 123.8(a)(3)(i) 36 Monitoring record review adequacy Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that are within critical limits].  Specifically, ***
3080 21 CFR 114.83 34 Scheduled process establishment A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.  Specifically, ***
3647 21 CFR 110.10(c) 34 Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].  Specifically, ***
1132 21 CFR 110.40(a) 32 Food-contact - unlawful indirect additives Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.  Specifically, ***
918 21 CFR 123.8(a) 31 Verification - reviewers qualifications The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.  Specifically, ***
6019 21 CFR 123.8(a)(2) 31 Ongoing verification - complaints, calibration records Your verification procedures do not include, at a minimum, ongoing verification activities including [review of consumer complaints] [calibration of process monitoring instruments] [review of monitoring, corrective action, and calibration records].  Specifically, ***
3086 21 CFR 114.100(b) 30 Maintenance of processing and production records Failure to maintain [processing] [production] records showing adherence to the scheduled processes, including records of [pH measurement] [critical factors] intended to ensure a safe product.  Specifically, ***
1184 21 CFR 110.35(e) 28 Storage of cleaned portable equipment (S) Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-contact surfaces from contamination.  Specifically, ***
1403 21 CFR 110.10(b)(4) 28 Hand jewelry - remove/cover Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand.  Specifically, ***
2393 21 CFR 110.80(b)(1) 28 Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, ***
9930 21 CFR 120.6(c) 28 SSOP records You do not [always] maintain sanitation standard operating procedure records that document [the monitoring of conditions and practices during processing] [corrections to conditions and practices that were not met].  Specifically, ***
1130 21 CFR 110.40(a) 27 Food-contact - withstand food & cleaning cmpds. Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand the action of food] [withstand cleaning compounds and sanitizing agents].  Specifically, ***
932 21 CFR 123.7(d) 25 Corrective action documentation You do not have records that document corrective actions that were taken.  Specifically, ***
2361 21 CFR 110.80 25 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
1425 21 CFR 110.20(b)(4) 24 Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].  Specifically, ***
3655 21 CFR 110.37(d)(2) 24 Good repair Failure to keep toilet facilities in good repair.  Specifically, ***
1090 21 CFR 110.40(d) 23 Holding, conveying, mfg systems - design & construction Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition.  Specifically, ***
3073 21 CFR 114.80(a)(2) 23 pH testing Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher than 4.6.  Specifically, ***
1129 21 CFR 110.40(a) 22 Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces.  Specifically, ***
3712 21 CFR 110.93 22 Storage/transportation of finished goods (deterioration) Failure to [store] [transport] finished food under conditions that would protect against deterioration of the food and its container.  Specifically, ***
1561 21 CFR 110.35(c) 21 Insecticides/rodenticides Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
2384 21 CFR 110.80(a)(7) 21 Receipt/storage - liquid and dry raw materials Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination.  Specifically, ***
6009 21 CFR 123.8(a)(3)(iii) 21 Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made.  Specifically, ***
6016 21 CFR 123.6(c)(7) 21 Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points.  Specifically, ***
1766 21 CFR 110.35(b)(1) 20 Unacceptable toxic compounds Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations.  Specifically, ***
2396 21 CFR 110.80(b)(6) 20 Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination.  Specifically, ***
3078 21 CFR 114.80(b) 20 Code - required elements Each container is not marked with an identifying code specifying the [establishment where the product was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
9941 21 CFR 120.8(a) 20 No HACCP plan You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur.  Specifically, ***
12742 21 CFR 120.8(a) 20 HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan.  Specifically, ***
986 21 CFR 110.10(b)(2) 19 Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.  Specifically, ***
2385 21 CFR 110.80(a)(1) 19 Inspection, segregation, handling of raw materials Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food.  Specifically, ***
3071 21 CFR 114.80(a)(1) 19 Scheduled process Acidified food is not manufactured in accordance with the scheduled process.  Specifically, ***
3657 21 CFR 110.37(d)(4) 19 Doors opening into processing areas Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination.  Specifically, ***
4479 21 CFR 108.25(e) 18 Recall procedures Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining the effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
6017 21 CFR 123.7(c) 18 Corrective action per regulation You did not take corrective action that ensured [the affected product was segregated] [a review of the affected product was done to determine its acceptability] [affected product was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation and modified as necessary].  Specifically, ***
6022 21 CFR 123.12(c) 18 Lack of records You do not have records to document the performance and results of the affirmative steps taken to demonstrate that [fish] [fishery products] imported into the United States were processed in accordance with the seafood HACCP regulation.  Specifically, ***
2394 21 CFR 110.80(b)(6) 17 Contamination by raw materials, refuse, other ingredients Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] .  Specifically, ***
9947 21 CFR 120.11(b) 17 HACCP plan - not validated You did not validate that your HACCP plan is adequate to control food hazards [at least once within 12 months after implementation] [at least annually] [when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way].  Specifically, ***
9954 21 CFR 120.11(a)(1)(iv) 17 Verification - CCP, CA record review You did not review [all of] your [critical control point monitoring] [corrective action] records within one week (7 days) of the day the records are made.  Specifically, ***
3085 21 CFR 114.100(a) 16 Raw materials, packaging, finished product Records are not maintained of the examination of [raw materials] [packaging materials] [finished products] [supplier's guarantees or certificates] to verify compliance with FDA regulations and guidelines or action levels.  Specifically, ***
3660 21 CFR 110.37(e)(4) 16 Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands.  Specifically, ***
4181 21 CFR 113.89 16 Process deviation identification Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control.  Specifically, ***
4421 21 CFR 110.20(a) 16 Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, *** 
6014 21 CFR 123.6(c)(2) 16 Monitoring - none Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance with the critical limit.  Specifically,
9935 21 CFR 120.7(a) 15 No hazard analysis You did not develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for [each type of]  juice you produce.  Specifically, *** 
.  Specifically, ***
15797 21 CFR 111.553 15 Written procedures - product complaint  You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint.  Specifically, ***
950 21 CFR 123.12(d) 14 Determination of compliance You have not provided evidence that the [fish] [fishery products] you import have been processed under conditions that comply with the Seafood HACCP regulation.  Specifically, ***
1577 21 CFR 110.37(f) 14 Contamination of food, contact surfaces, water supplies, etc The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces].  Specifically, ***
3075 21 CFR 114.80(a)(4) 14 Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.  Specifically, ***
3662 21 CFR 110.37(e)(6) 14 Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food.  Specifically, ***
9939 21 CFR 120.7(c) 14 All hazards not considered In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the evaluation for you] did not consider [microbiological contamination] [parasites] [chemical contamination] [unlawful pesticide residues] [decomposition] [natural toxins] [use of unapproved color or food additives] [presence of undeclared ingredients that may be allergens] [physical hazards].  Specifically, ***
9955 21 CFR 120.11(a)(1) 14 Verification activities - minimum Your verification activities do not include, at a minimum, [review of consumer complaints to determine whether they relate to the performance of the HACCP plan] [calibration of process monitoring instruments] [end-product or in-product testing] [review of critical control point monitoring, corrective action, and calibration records] to ensure that your HACCP system is being properly implemented.  Specifically, ***
12745 21 CFR 120.8(b)(1) 14 HACCP plan - food hazards not listed Your HACCP plan does not list all food hazards that are reasonably likely to occur.  Specifically, ***
1642 21 CFR 113.100(b) 13 Review not signed/dated Failure of the reviewer to [sign or initial] [date] the [processing records] [production records] [recording temperature chart(s)] after the completion of the processing of a low-acid food product.  Specifically, ***
1708 21 CFR 110.80(b)(12) 13 Batters, breading, gravies, sauces, etc. Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in a manner that protects against [contamination] [growth of microorganisms].  Specifically, ***
9958 21 CFR 120.12(c) 13 Records - signed/dated Your [written hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were] not signed and dated [upon initial acceptance] [upon modification] [upon verification] [upon validation] [by the most responsible individual onsite at the processing facility or by a higher level official].  Specifically, ***
15927 21 CFR 111.103 13 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations.  Specifically, ***
1566 21 CFR 110.35(d)(4) 12 Single-service articles Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects against the contamination of food and food-contact surfaces.  Specifically, ***
3067 21 CFR 114.80(a) 12 Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard.  Specifically, "***
3645 21 CFR 110.10(d) 12 Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel  has not been assigned to competent supervisory personnel.  Specifically, ***
3663 21 CFR 110.40(e) 12 Lack of automatic control / alarm (S) Lack of [an automatic control for regulating  temperature] [an automatic temperature alarm system] for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.  Specifically, ***
4515 21 CFR 108.35(c)(2) 12 Process filing Failure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each container.  Specifically, ***
12747 21 CFR 120.8(b)(3) 12 HACCP plan - critical limits not listed or not adequate Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control point] [lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food hazard].  Specifically, ***
12755 21 CFR 120.11(a)(1)(iv)  12 Records - not signed and dated by qualified individual Your review of [critical control point monitoring records] [corrective action records] [calibration records] [periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual who is trained in the application of HACCP principles to juice processing or otherwise qualified through job experience. Specifically, ***
975 21 CFR 123.9(b)(1) 11 Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period.  Specifically, ***
1288 21 CFR 110.20(a)(2) 11 Roads/yards/parking lots Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is exposed. Specifically, ***
2389 21 CFR 110.80(a)(5) 11 Identify rework Failure to identify material scheduled for rework as such. Specifically, ***
3082 21 CFR 114.89 11 Process deviation Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of the finished product higher than 4.6].  Specifically, ***
4296 21 CFR 110.80(a)(5) 11 Temperature and humidity Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated.  Specifically, ***
4464 21 CFR 108.25(c)(1) 11 Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of acidified foods. Specifically, ***
6012 21 CFR 123.8(a)(3)(iii) 11 Calibration record review adequacy Your review of [calibration] [in-process testing][end-product testing] records does not ensure [that the records are complete] [that the activities occurred in accordance with your written procedures] [occurred within a reasonable time after the records were made]. Specifically, *** 
9928 21 CFR 120.12(b) 11 Records - general - include name, date, time Your required records do not [always] include [the name of the processor] [the name of the importer] [the location of the processor] [the location of the importer] [the date and time of the activity] [the signature or initials of the person performing the operation or creating the record] [the identity of the product] [the production code].  Specifically, ***
9932 21 CFR 120.6(a) 11 Sanitation SSOP - none or not implemented You do not [always] have or have not implemented a sanitation standard operating procedure that addresses sanitation conditions and practices before, during and after processing.  Specifically, ***
12721 21 CFR 1.234 11 Registration not updated You did not submit an update to your facility's registration within 60 calendar days of [a change] [changes] to the registration information previously submitted.  Specifically, ***
12746 21 CFR 120.8(b)(2) 11 HACCP plan - critical control points not listed Your HACCP plan does not list the critical control points for each of the identified food hazards.  Specifically, ***
15858 21 CFR 111.75(a)(1)(i) 11 Component -  verify identity, dietary ingredient  You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.  Specifically, ***
938 21 CFR 123.9(c) 10 Official review You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations.  Specifically, ***
1060 21 CFR 123.11(a) 10 SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).  Specifically, ***
1601 21 CFR 110.37(a) 10 Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.  Specifically, ***
1697 21 CFR 110.80(b)(4) 10 Preventive control measures Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control] [water activity control] to destroy or prevent the growth of undesirable microorganisms in food.  Specifically, ***
3062 21 CFR 114.10 10 Personnel Operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner.  Specifically, ***
4475 21 CFR 108.25(c)(3)(i) 10 Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
9919 21 CFR 120.10(a) 10 Corrective action - predetermined plan inadequate You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, ***
12734 21 CFR 120.12(a) 10 Records required - not maintained You do not maintain [complete] records documenting [the implementation of your sanitation standard operating procedure] [your written HACCP plan] [your written hazard analysis] [monitoring of critical control points and their critical limits] [corrective actions taken in response to a deviation] [the verification of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard analysis].  Specifically, ***
12744 21 CFR 120.8(b)(4) 10 HACCP plan - monitoring procedures - none listed Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance with the critical limits.  Specifically, ***
15532 21 CFR 111.255(b)   10 Batch record - complete Your batch production record did not include complete information relating to the production and control of each batch.  Specifically, ***
15642 21 CFR 111.455(a) 10 Hold - temperature, humidity, light  You did not hold [components] [dietary supplements] under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.  Specifically, ***
15762 21 CFR 111.205(a) 10 Master manufacturing record - each batch  You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary supplement that you manufactured.  Specifically, ***
1196 21 CFR 110.10(a) 9 Employees with illness,  lesions, contamination source Employees  who appear to have an [illness] [open lesion] [abnormal source of microbial contamination] are not excluded from operations where there is a reasonable possibility of [food] [food contact surfaces] [food packaging materials] becoming contaminated.  Specifically, ***
1316 21 CFR 113.87(c) 9 Initial temperature The initial temperature of the contents of a container to be processed was [not determined] [not recorded] with sufficient frequency to ensure the temperature was not lower than the minimum initial temperature stated in the scheduled process.  Specifically, ***
1568 21 CFR 110.35(d)(2) 9 Before use and after interruption Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been contaminated], to preclude contamination with microorganisms.  Specifically, ***
1711 21 CFR 110.80(b)(15) 9 Proper pH controls Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the control of pH to prevent the growth of undesirable microorganisms.  Specifically, ***
3088 21 CFR 114.100(b) 9 Processing and production - required information The [processing] [production] records do not contain sufficient additional information such as [product code] [date] [container size] [product] to permit a public health hazard evaluation of the processes applied to each [lot] [batch] [portion] of production.  Specifically, ***
6002 21 CFR 123.11(b) 9 Sanitation corrections You did not correct sanitation deficiencies in a timely manner.  Specifically,***
15494 21 CFR 111.25(c) 9 Procedures - equipment - cleaning, sanitizing You  did not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing,  equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.  Specifically, ***
972 21 CFR 123.8(a)(1) 8 Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate.  Specifically, ***
1176 21 CFR 110.40(f) 8 Insufficient number of Q.C. instruments An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms.  Specifically,***
1290 21 CFR 110.20(a)(4) 8 Waste disposal Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where food is exposed.  Specifically, ***
1529 21 CFR 113.89 8 Process deviation log/file Process deviations were not recorded in a separate file or log that details both the deviations and the actions taken.  Specifically, ***
1641 21 CFR 113.100(b) 8 Review not done/timely A review of processing and production records by a qualified representative of plant management was not done [within one working day after the completion of  the process] [before shipment or release for distribution] to determine [completeness of the records] [whether product was processed as specified by the scheduled process].  Specifically, ***
1669 21 CFR 110.80(a)(3) 8 Aflatoxin and other natural toxins There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food.  Specifically, ***
3877 21 CFR 113.60(c) 8 Coding - required elements The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed]  [period during which packed].  Specifically, ***
4179 21 CFR 113.83 8 Records of process establishment Failure to maintain complete records covering all aspects of the establishment of the [process] [associated incubation tests] by the person or organization making the determination.  Specifically, ***
15410 21 CFR 111.14(b)(2) 8 Personnel - records - training You did not make and keep documentation of training.  Specifically, ***
15763 21 CFR 111.205(a)  8 Master manufacturing record - unique formulation  You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.  Specifically, ***
15862 21 CFR 111.75(a)(2) 8 Appropriate tests, examinations; certificate of analysis You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.  Specifically, ***
16042 21 CFR 111.503 8 Written procedures - returned dietary supplement  You did not [establish] [follow] written procedures for when a returned dietary supplement is received.  Specifically, ***
899 21 CFR 123.16 7 Process controls Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
1330 21 CFR 113.100(a) 7 Processing entry missing information Forms used to record processing or production information lack the [product] [code number] [date] [retort or processing system number] [container size] [approximate number of containers per coding interval] [initial temperature] [actual processing time] [mercury-in-glass thermometer readings] [recording thermometer readings] [appropriate processing data].  Specifically, ***
1665 21 CFR 110.80(a)(2) 7 Pasteurization or other adequate treatment [Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or other disease are not pasteurized or otherwise adequately treated.  Specifically, ***
1688 21 CFR 110.80 7 Supervisory competence The function of supervising overall sanitation of the plant has not been designated to  the supervision of  one or more competent individuals assigned responsibility for this function.  Specifically, ***
2427 21 CFR 110.80(b)(9) 7 Proper disposal of adulterated product Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food.  Specifically, ***
9943 21 CFR 120.8(a) 7 HACCP plan - location and type of juice Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed].  Specifically, ***
9961 21 CFR 120.24(a) 7 Process controls - HACCP plan - 5 log reduction Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product.  Specifically, ***
12749 21 CFR 120.8(b)(6) 7 HACCP plan - verify procedures / frequency - none listed Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented.  Specifically, ***
15659 21 CFR 111.475(b)(1) 7 Written procedures - holding; distributing  You did not make and keep written procedures for holding and distributing operations.  Specifically, ***
15839 21 CFR 111.70(e)  7 Specifications - identity, purity, strength, composition  You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement.  Specifically, ***
15869 21 CFR 111.75(c) 7 Specifications met - verify; finished batch  You did not verify that your finished batch of dietary supplement meets product specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].  Specifically, ***
1329 21 CFR 113.100(a) 6 Processing entries not done/not timely Required information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person.  Specifically, ***
1428 21 CFR 110.20(b)(6) 6 Adequate ventilation Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food.  Specifically, ***
1471 21 CFR 113.83 6 Scheduled processes not established Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing.  Specifically, ***
1487 21 CFR 113.87(b) 6 Visual indicators not used Heat-sensitive indicators or other means are not used to visually show that a thermal process has been applied to containers in a retort basket, truck, car, or crate used to hold containers in a retort.  Specifically, ***
2887 21 CFR 113.40(j) 6 Conform to requirements The system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers [did not conform to the applicable requirements of 21 CFR 113.40] [did not conform to methods and controls specified in the scheduled process] [were not operated and administered in a manner that ensures commercial sterility is achieved].  Specifically, ***
3072 21 CFR 114.80(a)(1) 6 Thermal processing Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of growing in the food.  Specifically, ***
3089 21 CFR 114.100(c) 6 Process deviations- identification and records Departures from a scheduled process having a possible bearing on public health or the safety of a food are not [noted] [identified] [recorded] [made the subject of a separate file (or log identifying the appropriate data) delineating them].  Specifically, ***
3090 21 CFR 114.100(d) 6 Product distribution Records identifying initial distribution of finished product are not maintained.  Specifically, ***
3650 21 CFR 110.35(d)(1) 6 Wet cleaning Failure to sanitize and thoroughly dry, prior to use,  food-contact surfaces which have been wet cleaned.  Specifically, ***
3651 21 CFR 110.37(b)(5) 6 Cross contamination Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing.  Specifically, ***
3857 21 CFR 113.60(a) 6 Record of visual closure examination Failure to record observations of visual closure examinations performed by a qualified person during production.  Specifically, ***
3872 21 CFR 113.60(a)(3) 6 Closures other than double seams and glass Failure to [have a qualified person] perform appropriate detailed inspections and tests [at intervals of sufficient frequency] to ensure proper closing machine performance and consistently reliable hermetic seal production.  Specifically, ***
4295 21 CFR 110.40(a) 6 Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials.  Specifically, ***
12733 21 CFR 120.11(a)(1)(iv)(C) 6 Calibration, testing - record review timeliness You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records within a reasonable time after the records were made.  Specifically, ***
12743 21 CFR 120.8(b)(4) 6 HACCP plan - monitoring procedures not adequate Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits.  Specifically, ***
15302 21 CFR 120.11(a)(2) 6 Calibration, testing - no records You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
15498 21 CFR 111.27(d) 6 Equipment - maintain, clean, sanitize You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or hold components or dietary supplements.  Specifically, ***
15641 21 CFR 111.453  6 Written procedures - holding  You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, ***
15853 21 CFR 111.73 6 Specifications met - identity, purity, strength, composition You did not determine whether you met established product specifications for [identity] [purity] [strength] [composition of the finished batch of the dietary supplement].  Specifically, ***
15861 21 CFR 111.75(a)(2)(ii)(A)   6 Component - qualify supplier  You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.  Specifically, ***
15897 21 CFR 111.83(a) 6 Reserve sample - collect, hold  You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.  Specifically, ***
17004 FDCA 402(a) 6 Food Field Exam During a field examination of food products at your facility the following [was] [were] observed:
929 21 CFR 123.8(b) 5 Verification - corrective action You did not take immediate corrective action to ensure that [no affected product entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed] when your verification procedure revealed the need to take a corrective action.  Specifically, ***
949 21 CFR 123.12(c) 5 Records, English The records that document the performance and results of the affirmative step you chose are not in English.   Specifically, ***
976 21 CFR 123.9(b)(2) 5 Process adequacy records The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their applicability to the product you produced.  Specifically, ***
1040 21 CFR 113.10 5 Operators Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems] are not under the operating supervision of a person that has attended  and satisfactorily completed, a school approved by the Commissioner.  Specifically, ***
1045 21 CFR 113.10 5 Supervisors Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility.   Specifically, ***
1639 21 CFR 113.100(b) 5 Entries not timely Entries on [processing records] [production records] were not made at the time the specific retort or processing system condition or operation occurred.  Specifically, ***
1706 21 CFR 110.80(b)(10) 5 Mechanical manufacturing control Failure to perform mechanical manufacturing steps so as to protect food against contamination.  Specifically, ***
2301 21 CFR 129.80(f) 5 Bacteriological contamination of containers and closures (S) You do not  take a bacteriological swab and/or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.  Specifically, ***
2387 21 CFR 110.80(a)(1) 5 Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.  Specifically, ***
2391 21 CFR 110.80(a)(6) 5 Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated.  Specifically, ***
3644 21 CFR 110.10(b)(5) 5 Impermeable (S) Gloves used for food handling are not impermeable.  Specifically,  ***
3881 21 CFR 113.60(d) 5 Post process handling - automatic equipment design (S) Automatic equipment used to handle filled containers is not designed or operated so as to preserve the can seam or other container closure integrity.  Specifically, ***
4519 21 CFR 108.35(c)(3)(i) 5 Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
4524 21 CFR 108.35(g) 5 Approved school Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and packaging systems] [thermal processing systems] [container closure inspections] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
9936 21 CFR 120.7(a) 5 Hazard analysis - written - elements Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each food hazard identified to determine if it must be addressed in the HACCP plan] [an identification of the control measures that can be applied] [a review of your current process to determine whether modifications are necessary] [an identification of critical control points].  Specifically, ***
9986 21 CFR 120.24(c) 5 Process controls - not exempt, single facility You do not conduct the 5-log reduction process and perform final packaging of your juice within a single production facility operating under current good manufacturing practices. Specifically, ***
15401 21 CFR 111.12(b) 5 Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations.  Specifically, ***
15402 21 CFR 111.12 5 Personnel - quality control personnel - qualified The personnel you identified to perform quality control operations [are not qualified to do so] [do not have the education, training or experience to perform the assigned functions].  Specifically, ***
15425 21 CFR 111.15(i) 5 Hand-washing facilities Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature].  Specifically, *** 
15434 21 CFR 111.15(d)(2) 5 Pest control measures You did not take effective measures [to exclude pests from the physical plant] [to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests].  Specifically, ***
15443 21 CFR 111.15(b)(2) 5 Physical plant - repair You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.  Specifically, ***
15454 21 CFR 111.16 5 Written procedures - pest control You did not [establish] [follow] written procedures for pest control.  Specifically, ***
15550 21 CFR 111.260(j) 5 Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, ***
15723 21 CFR 111.365(i) 5 Metal, foreign material  You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements].  Specifically, ***
15736 21 CFR 111.353   5 Manufacturing operations - written procedures  You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, ***
15928 21 CFR 111.103 5 Written procedure quality control operations material review You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision.  Specifically, ***
16013 21 CFR 111.140(b)(1)   5 Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, ***
977 21 CFR 123.9(b)(3) 4 Records stored at another location You did not immediately return your records for official review upon demand.  Specifically, ***
1255 21 CFR 129.20(a) 4 Bottling room separation The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.  Specifically, ***
1473 21 CFR 113.83 4 Scientific methods not performed No acceptable scientific methods of establishing heat sterilization processes or procedures recognized by competent processing authorities were used in the determination of the scheduled process.  Specifically, ***NOTE: CFSAN CONCURRENCE REQUIRED.
1500 21 CFR 113.89 4 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  Specifically, ***
1600 21 CFR 110.37(a) 4 General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].  Specifically, ***
1643 21 CFR 113.100(c) 4 Incomplete information Written records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions taken].  Specifically, ***
1660 21 CFR 113.40(a)(1) 4 MIG thermometer not used as reference The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
1670 21 CFR 110.80(a)(4) 4 Safety assurance - pests/extraneous materials There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels.  Specifically, ***
1761 21 CFR 129.80(a) 4 Record keeping requirements You do not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the [type and date] [conditions found] [performance and effectiveness of equipment].  Specifically, ***
1812 21 CFR 129.80(c) 4 Testing of cleaning/sanitizing solutions You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, ***
1945 21 CFR 129.80(d) 4 Records of sanitizing times and intensities (S) You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in contact with the surface being sanitized].  Specifically, ***
2362 21 CFR 110.80 4 Reject and rework Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..  Specifically, ***
3077 21 CFR 114.80(b) 4 Visible code Each container is not marked with an identifying code permanently visible to the naked eye.  Specifically, ***
3653 21 CFR 110.37(d) 4 Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, ***
3823 21 CFR 113.40(b)(1) 4 Records of calibration (S) Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test].  Specifically, ***
15550 21 CFR 111.260(j) 5 Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, ***
15723 21 CFR 111.365(i) 5 Metal, foreign material  You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements].  Specifically, ***
15736 21 CFR 111.353   5 Manufacturing operations - written procedures  You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, ***
15928 21 CFR 111.103 5 Written procedure quality control operations material review You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision.  Specifically, ***
16013 21 CFR 111.140(b)(1)   5 Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, ***
977 21 CFR 123.9(b)(3) 4 Records stored at another location You did not immediately return your records for official review upon demand.  Specifically, ***
1255 21 CFR 129.20(a) 4 Bottling room separation The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.  Specifically, ***
1473 21 CFR 113.83 4 Scientific methods not performed No acceptable scientific methods of establishing heat sterilization processes or procedures recognized by competent processing authorities were used in the determination of the scheduled process.  Specifically, ***NOTE: CFSAN CONCURRENCE REQUIRED.
1500 21 CFR 113.89 4 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  Specifically, ***
1600 21 CFR 110.37(a) 4 General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].  Specifically, ***
1643 21 CFR 113.100(c) 4 Incomplete information Written records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions taken].  Specifically, ***
1660 21 CFR 113.40(a)(1) 4 MIG thermometer not used as reference The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
1670 21 CFR 110.80(a)(4) 4 Safety assurance - pests/extraneous materials There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels.  Specifically, ***
1761 21 CFR 129.80(a) 4 Record keeping requirements You do not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the [type and date] [conditions found] [performance and effectiveness of equipment].  Specifically, ***
1812 21 CFR 129.80(c) 4 Testing of cleaning/sanitizing solutions You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, ***
1945 21 CFR 129.80(d) 4 Records of sanitizing times and intensities (S) You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in contact with the surface being sanitized].  Specifically, ***
2362 21 CFR 110.80 4 Reject and rework Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..  Specifically, ***
3077 21 CFR 114.80(b) 4 Visible code Each container is not marked with an identifying code permanently visible to the naked eye.  Specifically, ***
3653 21 CFR 110.37(d) 4 Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, ***
3823 21 CFR 113.40(b)(1) 4 Records of calibration (S) Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person performing the test].  Specifically, ***
15744 21 CFR 111.210(h)(2)   4 Master manufacturing record - sampling, tests, examinations  The written instructions in your master manufacturing record did not include [procedures for sampling] [a cross-reference to procedures for tests or examinations]. Specifically, ***
15748 21 CFR 111.210(f) 4 Master manufacturing record theoretical yield,expected yield Your master manufacturing record did not include a statement of [the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished dietary supplement.]  Specifically, ***
15761 21 CFR 111.205(b)(1) 4 Master manufacturing record - specifications; quality  Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.  Specifically, ***
15790 21 CFR 111.403  4 Written procedures - labeling operations  You did not [establish] [follow] written procedures for labeling operations.  Specifically, ***
15819 21 CFR 111.55 4 Production, process controls - implement  You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement.  Specifically, ***
15825 21 CFR 111.65 4 Quality control - quality, dietary supplement  You did not implement quality control operations to ensure the quality of the dietary supplement.  Specifically,  ***
15830 21 CFR 111.70(b)(2) 4 Specifications-component purity, strength, composition  You did not establish component specifications for [purity] [strength] [composition].  Specifically, ***
15872 21 CFR 111.75(c)(3) 4 Specifications met identity,purity, strength, comp,; basis  You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specification[s]. Specifically, ***
15951 21 CFR 111.110(c)   4 Quality control operations - tests, examinations; results Your quality control operations did not include reviewing and approving the results of required [tests] [examinations].  Specifically, ***
16083 21 CFR 111.35(b)(6)   4 Documentation - equipment functions; intended use  You did not make and keep documentation of the controls you use to ensure that equipment functions according to its intended use.  Specifically, ***
1303 21 CFR 113.81(f) 3 Critical Factors The critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal process are not controlled in a manner to ensure the limits established are not exceeded.   Specifically, ***
1353 21 CFR 129.35(a)(3)(i) 3 Sampling for micro contaminants The [product] [operations] source water that is obtained from other than a public water system is not sampled and analyzed for microbiological contaminants at least once each week.  Specifically, ***
1379 21 CFR 129.35(a)(4)(iv) 3 Compliance with standards Finished bottled water does not comply with bottled water quality standards.  Specifically, ***
1483 21 CFR 113.87(a) 3 Operating processes not posted Operating processes for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators].  Specifically, ***
1534 21 CFR 113.100(b) 3 Entries not done Required entries on [processing records] [production records] were not made by the retort or processing system operator or other designated person for specific retort operations or conditions specified in the scheduled process.  Specifically, ***
1559 21 CFR 110.35(c) 3 Guard/guide dogs The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
1645 21 CFR 113.100(c) 3 Records review infrequent / not done Written records of all container closure examinations are [not reviewed by management] [not reviewed by management with sufficient frequency] to ensure that the containers are hermetically sealed.  Specifically, ***
1651 21 CFR 113.40(a)(1) 3 Thermometer calibration Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy.  Specifically, ***
1734 21 CFR 113.40(a)(2) 3 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing.  Specifically, ***
1751 21 CFR 113.40(a)(8) 3 Size, fully open Bleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time].  Specifically, ***
1806 21 CFR 129.80(b)(1) 3 Records of mechanical washers You do not keep records of [inspection and conditions found] [physical maintenance] [performance] for mechanical washers.  Specifically, ***
2056 21 CFR 123.28(a) 3 HACCP plan Your HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved source.  Specifically, ***
3859 21 CFR 113.60(a) 3 Frequency of visual closure examinations (S) Failure to record visual container closure observations [at intervals of thirty (30) minutes or less] [following a jam in a closing machine] [after closing machine adjustment] [after startup following a prolonged shutdown].  Specifically, ***
3865 21 CFR 113.60(a)(1) 3 Corrective actions following teardown examinations Failure to note corrective actions taken following teardown examination of double seam cans.  Specifically, ***
3874 21 CFR 113.60(b) 3 Cooling water - failure to chlorinate, etc. Failure to chlorinate or otherwise sanitize container cooling water as necessary for cooling canals and recirculated water supplies.  Specifically, ***
3875 21 CFR 113.60(b) 3 Cooling water - residual sanitizer (S) No measurable residual of the cooling water sanitizer at the water discharge point of the container cooler.  Specifically, ***
3892 21 CFR 113.60(a) 3 Regular observations for gross closure defects Failure to make regular observations for gross closure defects during production runs.  Specifically ***
4465 21 CFR 114.100(c) 3 Process deviations - action to rectify Failure to record the action taken to rectify a departure from a scheduled process.  Specifically, ***
9946 21 CFR 120.11(b) 3 Validation - reviewer's qualifications Your [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who had successfully completed training in the application of HACCP principles to juice processing or otherwise qualified through job experience to perform these function.  Specifically, ***
9953 21 CFR 120.11(a)(1)(iv)(A) 3 CCP record review adequacy Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that are within critical limits].  Specifically, ***
9981 21 CFR 120.12(b)(4) 3 Records - actual values Your records do not [always] contain the actual values and observations obtained during monitoring.  Specifically, ***
15382 21 CFR 111.8 3 Written procedures - personnel qualifications You did not [establish] [follow] written procedures for determining personnel qualification requirements.  Specifically, ***
15409 21 CFR 111.14(b)(1) 3 Personnel - records - written procedures You did not make and keep written procedures for [preventing microbial contamination from sick or infected personnel] [hygienic practices] [determining personnel qualification requirements].  Specifically, ***
15442 21 CFR 111.15(b)(1) 3 Physical plant - clean and sanitary You did not maintain your physical plant in a clean and sanitary condition.  Specifically, ***
15453 21 CFR 111.16 3 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, ***
15458 21 CFR 111.20(d)(1)(i) 3 Floors, walls, ceilings Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and kept clean and in good repair.  Specifically, ***
15491 21 CFR 111.25 3 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, ***
15492 21 CFR 111.25(a) 3 Procedures - calibrating instruments You did not [establish] [follow] written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.  Specifically, ***
15531 21 CFR 111.255(a) 3 Batch record - every batch You did not prepare a batch production record every time you manufactured a batch of dietary supplement.  Specifically, ***
15534 21 CFR 111.255(c)   3 Batch record - each step You did not perform each step in the production of a batch, according to the master production record.  Specifically, ***
15546 21 CFR 111.260(f)  3 Batch record - yield Your batch production records did not include [a statement of the actual yield] [a statement of the percentage of theoretical yield] at appropriate phases of processing.  Specifically, ***
15570 21 CFR 111.153 3 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, ***
15572 21 CFR 111.153  3 Written procedures - labels  You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, ***
15604 21 CFR 111.165(b) 3 Product received - visually examine invoice, guarantee, cert You did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received product to ensure that the received product was consistent with your purchase order.  Specifically, ***
15605 21 CFR 111.165? 3 Product received - quarantine  You did not quarantine received product.  Specifically, ***
15675 21 CFR 111.315(b) 3 Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, ***
15747 21 CFR 111.210(g)  3 Packaging description, representative label  Your master manufacturing record did not include a [description of the packaging] [a representative label, or a cross-reference to the physical location of the actual or representative label].  Specifically, 
15759 21 CFR 111.205(b)(2) 3 Master manufacturing record - controls, procedures  Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,  ***
15778 21 CFR 111.415(b)  3 Dietary supplement - protect, contamination  You did not protect manufactured dietary supplements from contamination during [filling] [assembling] [packaging] [labeling] operations.  Specifically, ***
15791 21 CFR 111.403  3 Written procedures -packaging operations  You did not [establish] [follow] written procedures for packaging operations.  Specifically, ***
15801 21 CFR 111.560(b) 3 Quality control, review, approve; investigate, followup Your quality control personnel did not [review and approve decisions about whether to investigate a product complaint] [review and approve the findings and follow-up action of an investigation].  Specifically, ***
15829 21 CFR 111.70(b)(1) 3 Specifications - component identity  You did not establish an identity specification for each component.  Specifically, ***
15832 21 CFR 111.70(c)(1) 3 In-process identity, purity, strength, composition You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for [identity] [purity] [strength] [composition].  Specifically, ***
15842 21 CFR 111.70(f) 3 Specifications - product received for packaging, labeling  You did not establish specifications to [sufficiently] assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order.  Specifically, ***
15883 21 CFR 111.75(i)  3 Corrective action plan  You did not establish a corrective action plan to use when an established specification is not met.  Specifically, ***
15893 21 CFR 111.80(c) 3 Specifications - representative samples; finished batch  You did not collect representative samples [of a subset] of finished batches of dietary supplements that you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement meets established product specifications.  Specifically, ***
15935 21 CFR 111.105(d)   3 Quality control - basis; tests, examinations Your quality control personnel did not review and approve the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification will ensure that the finished batch of the dietary supplement meets product specifications.  Specifically, ***
15944 21 CFR 111.105(i)   3 QC - required operations master manufacturing/batch records  Your quality control personnel did not perform required operations for the [master manufacturing record] [batch record] [manufacturing operations]. Specifically, ***
15984 21 CFR 111.123(a)(8)   3 Quality control - finished batch, distribution Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution.  Specifically, ***
16057 21 CFR 111.535(b)(1) 3 Records - returned dietary supplement: written procedures  You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.  Specifically, ***
16070 21 CFR 111.35(b)(2) 3 Document-equipment date of use, maintain, clean, sanitize You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of the equipment.  Specifically, ***
16071 21 CFR 111.35(b)(3) 3 Documentation - instruments, controls; calibrations  You did not make and keep documentation of calibrations for instruments or controls that you use in manufacturing or testing a component or dietary supplement.  Specifically, ***
939 21 CFR 123.9(f) 2 Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  Specifically, ***
1093 21 CFR 110.40(g) 2 Compressed air/gases Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated with unlawful indirect food additives.  Specifically, ***
1197 21 CFR 110.10(a) 2 Lack of instruction/reporting of health conditions Personnel with  adverse health conditions are not instructed to report to their supervisors.  Specifically, ***
1277 21 CFR 129.20(d) 2 Enclosed room for container washing and sanitizing You do not [wash] [sanitize] containers for bottled drinking water in an enclosed room.  Specifically, ***
1294 21 CFR 110.20(b)(3) 2 Outdoor fermentation Proper precautions to protect food in outdoor bulk fermentation vessels cannot be taken because of deficiencies in plant [construction] [design].  Specifically, ***
1331 21 CFR 113.100(a)(1) 2 Still retorts Forms used in recording specific processing and production information for still retorts lack [the time that steam was turned on] [the time that the retort reached processing temperature] [the time that steam was shut off] [venting time] [venting temperature].  Specifically, ***
1351 21 CFR 129.35(a)(3)(i) 2 Sampling of product & ops water You do not take and analyze samples of [product] [operations] source water [as often as necessary] [at least once every year for chemical contamination] [at least once every four years for radiological contaminants].  Specifically, ***
1394 21 CFR 129.37(a) 2 Sanitization practices You do not adequately [clean] [sanitize] the product water-contact surfaces of all [multiservice containers] [utensils] [pipes] [equipment] used in the [transportation] [processing] [handling] [storage] of product water.  Specifically, ***
1423 21 CFR 129.37(d) 2 Containers kept sanitary You do not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude contamination of the bottled drinking water.  Specifically, ***
1533 21 CFR 113.100(b) 2 RTC identification Recording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed].  Specifically ***
1595 21 CFR 110.37(b)(1) 2 Sufficient quantities of water Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required locations throughout the plant.  Specifically, ***
1648 21 CFR 113.40(a)(1) 2 No MIG thermometer Failure to install a mercury-in glass thermometer on each retort.  Specifically, ***
1735 21 CFR 113.40(a)(2) 2 Unauthorized adjustment There was no means to prevent unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
1757 21 CFR 113.40(a)(8) 2 Observable Failure to install bleeders so that the operator can observe that they are functioning properly.  Specifically, ***
1944 21 CFR 129.80(d) 2 Sanitizing operations inadequate Sanitizing operations are not adequate to effect sanitation of the intended product water-contact surfaces and critical areas.  They do not meet the minimum times and intensities required by the regulations.  Specifically, ***
2115 21 CFR 113.40(b)(8) 2 Drain valve Failure to install a [nonclogging] [water tight] drain valve [with screened openings].  Specifically, ***
2142 21 CFR 113.40(b)(1) 2 No MIG thermometer Failure to install a mercury-in glass thermometer on each retort.  Specifically, ***
2154 21 CFR 113.40(b)(2) 2 Unauthorized adjustment There was no means to prevent unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
2271 21 CFR 129.80(e) 2 Package identification You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production code which identifies [the particular batch] [the segment of production run] [the day produced].  Specifically, ***
2272 21 CFR 129.80(e) 2 Plant records You do not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of finished product to wholesale and retail outlets].  Specifically, ***
2273 21 CFR 129.80(g) 2 Representative samples Samples for [bacteriological] [chemical] [physical] [radiological] analysis are not primary containers or unit packages from a batch or segment of a continuous run for each type of bottled drinking water.  Specifically, ***
2274 21 CFR 129.80(g)(1) 2 Bacteriological You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled drinking water produced during a day's production run].  Specifically, ***
2321 21 CFR 113.40(c)(2) 2 Unauthorized adjustment There was no means of preventing unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
2367 21 CFR 129.80(a) 2 Effective treatment Your treatment of product water is not done in such a manner as to be effective in accomplishing the intended purpose.  Specifically, ***
2837 21 CFR 113.40(g)(4) 2 Critical factors Critical factors were not [measured] [recorded on the processing record] at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process.  Specifically, ***
2848 21 CFR 113.40(g)(1)(i)(b) 2 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] a known accurate mercury-in-glass thermometer.  Specifically, ***
2870 21 CFR 113.40(g)(1)(ii)(e) 2 Readings with sufficient frequency Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed]  [recorded] at intervals of sufficient frequency to ensure the values were as specified in the scheduled process for aseptic packaging operations.  Specifically ***
2901 21 CFR 113.40(i) 2 Critical factors Critical factors are not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process.  Specifically, ***
3068 21 CFR 114.80(a)(1) 2 pH control Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain]  a pH value of 4.6 or lower in all finished foods.  Specifically,  ***
3083 21 CFR 114.89 2 Process deviation evaluation Process deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health.  Specifically, ***
3091 21 CFR 114.100(e) 2 Retention Required records are not maintained at the processing plant or other reasonably accessible location for a period of three years from the date of manufacture. Specifically, ***
3093 21 CFR 114.89 2 Process deviation evaluation - record  Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations].  Specifically, ***
3648 21 CFR 110.20(a)(4) 2 Neighboring grounds Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control.  Specifically, ***
3709 21 CFR 110.80(a)(1) 2 Inspection of containers and carriers upon receipt Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does not contribute to the contamination or deterioration of food.  Specifically, ***
4530 21 CFR 114.100(c) 2 Process deviations - product disposition Failure to record the disposition of product involved in a departure from a scheduled process.  Specifically, ***
6011 21 CFR 123.8(a)(3)(ii) 2 Corrective action record review adequacy Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken].  Specifically, ***
9921 21 CFR 120.10(b) 2 Corrective action - no predetermined plan Your HACCP plan does not include a corrective action plan.  There was a deviation from a critical limit and you did not take corrective action that ensured [affected product was segregated and held] [a review of the affected product by someone who is adequately trained or experienced was done to determine its acceptability] [product that was injurious to health or otherwise adulterated was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan was verified by someone meeting the training requirements of the regulation to determine if modifications were needed to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary].  Specifically, ***
9929 21 CFR 120.12(b)(4) 2 Records - information not entered when observed Processing and other information is not [always] entered on your records at the time it is observed.  Specifically, ***
9964 21 CFR 120.25 2 Finished product not analyzed for E.coli You do not [always] analyze your finished juice product for biotype I Escherichia coli.   Specifically, ***
12703 21 CFR 129.80(a) 2 Product samples You do not take product water samples after processing and prior to bottling.  Specifically, ***
12704 21 CFR 129.80(a) 2 Analytical frequency You do not analyze product water samples as often as necessary to assure uniformity and effectiveness of the treatment processes performed by the plant.  Specifically, ***
12717 21 CFR 129.80(h) 2 Certificates You did not retain at the plant current certificates or notifications of approval issued by the government agency or agencies approving the source and supply of product water and operations water.  Specifically, ***
12732 21 CFR 120.10(a) 2 Corrective action - predetermined plan Your HACCP plan includes a corrective action plan.  There was a deviation from a critical limit and you did not take corrective action that ensured [product that was injurious to health or otherwise adulterated did not enter commerce] [the cause of the deviation was corrected].  Specifically, ***
15001 21 CFR 113.60(a) 2 Corrective actions When a teardown examination revealed gross closure defects, [adequate] corrective action was not taken.  Specifically, ***
15305 21 CFR 120.14(a)(2) 2 Importer - implementation of affirmative steps You have not implemented affirmative steps to ensure juice you receive for import into the United States was processed in accordance with the juice HACCP regulation. Specifically, *** 
15338 21 CFR 80.38(a) 2 Label with certified lot number Immediately after notification that a batch of color additive has been certified, the person requesting certification did not label the batch with the certified lot number.  Specifically, ***
15351 FDCA 761(b)(1) 2 No AE report made (dietary supplement) No report was made of a serious adverse event associated with a dietary supplement marketed in the United States.  Specifically, ***
15391 21 CFR 111.10(b)(3) 2 Hand washing Your personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing facility [before starting work] [at any time when the hands may have become soiled or contaminated].  Specifically, ***
15403 21 CFR 111.12(b) 2 Personnel - quality control operations; responsibilities The personnel you identified to perform quality control operations do not have distinct and separate responsibilities related to performing such operations from those responsibilities that the personnel otherwise have when not performing such operations.  Specifically, ***
15404 21 CFR 111.12(c) 2 Personnel - education, training, experience Personnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have the education, training, or experience to perform the person's assigned functions.  Specifically, ***
15429 21 CFR 111.15(k) 2 Sanitation supervisors - assigned You did not assign one or more employees to supervise overall sanitation.  Specifically, ***
15456 21 CFR 111.20(b) 2 Physical plant - space; equipment, materials Your physical plant did not have adequate space for the orderly placement of equipment and holding of materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination and mix-ups of components and dietary supplements].  Specifically, ***
15461 21 CFR 111.20(d)(1)(iii) 2 Physical plant - ventilation, environmental control Your physical plant did not have [adequate ventilation] [environmental control equipment] to minimize odors and vapors in areas where they may contaminate components, dietary supplements, or contact surfaces.  Specifically, *** 
15480 21 CFR 111.20(h) 2 Physical plant - screening against pests Your physical plant did not use adequate screening or other protection against pests.  Specifically, ***
15499 21 CFR 111.27(a) 2 Equipment - design - suitable You did not use equipment or utensils of appropriate design, construction, and workmanship to enable them to be [suitable for its intended use] [adequately cleaned] [properly maintained].  Specifically, ***
15544 21 CFR 111.260(d) 2 Batch record - component; unique identifier Your batch production records did not include the unique identifier that you assigned to [a component] [a product that you received from a supplier for packaging or labeling as a dietary supplement] [the packaging used] [the label used].  Specifically, ***
15547 21 CFR 111.260(g) 2 Batch record - results; monitoring Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,  ***
15552 21 CFR 111.260(j)(2)  2 Batch record - initials; each step Your batch production records did not include initials of the persons performing each step.  Specifically, ***
15562 21 CFR 111.260(l)(1) 2 Batch record - quality control review; production Your batch production records did not include documentation that quality control personnel reviewed the batch production record.  Specifically, ***
15579 21 CFR 111.155(c)(1) 2 Components - representative samples You did not collect representative samples of components while the components were quarantined.  Specifically, ***
15582 21 CFR 111.155(e) 2 Components - contamination, deterioration, mixups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  Specifically, ***
15584 21 CFR 111.155(d)(1) 2 Components - identify lot produced  You did not identify each lot of components that you produced in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed].  Specifically, ***
15598 21 CFR 111.160(d)(1) 2 Packaging - identify  You did not identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the packaging] [the dietary supplement that you distributed].  Specifically, ***
15619 21 CFR 111.180(b)(1)  2 Written procedures - packaging, labeling received  You did not make and keep written procedures for fulfilling the requirements that apply to packaging and labeling received.  Specifically, ***
15645 21 CFR 111.455(c) 2 Hold - mixup, contamination, deterioration  You held [components] [dietary supplements] [packaging] [labels] under conditions that  lead to mix-up, contamination, or deterioration. Specifically, ***
15648 21 CFR 111.465(a)(2) 2 Hold - reserve sample; closure system  Your reserve sample of a dietary supplement was not held using the same container-closure system in which the packaged and labeled dietary supplement was distributed.  Specifically, ***
15702 21 CFR 111.320(b)  2 Examination, testing; scientifically valid You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.  Specifically, ***
15708 21 CFR 111.325(a) 2 Written procedures, laboratory operations You did not make and keep written procedures for laboratory operations. Specifically, ***
15712 21 CFR 111.325(b)(2)(ii) 2 Records - document; results  The documentation for laboratory tests and examinations did not include the results of the testing and examination.  Specifically, ***
15733 21 CFR 111.365  2 Manufacturing operations - prevent contamination  You did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of [components] [dietary supplements].  Specifically, ***
15752 21 CFR 111.210(c) 2 Master manufacturing record - components; weight, measure  Your master manufacturing record did not include an accurate weight or measure of each component to be used.  Specifically, ***
15768 21 CFR 111.420(c)   2 Repackaged, relabeled - quality control: approve, rejects  Your quality control personnel did not approve or reject each batch of [repackaged] [relabeled] dietary supplement prior to its release for distribution.  Specifically, ***
15771 21 CFR 111.415(h)  2 Obsolete labels, packaging - dispose  You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations.  Specifically, ***
15775 21 CFR 111.415(e)  2 Dietary supplement containers - mixups  You did not [identify] [identify by effective means] filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mix-ups.  Specifically, ***
15776 21 CFR 111.415(d)   2 Packaging, labeling - physical separation  You did not establish physical or spatial separation of [packaging] [label] operations from operations on other components and dietary supplements to prevent mix-ups.  Specifically, ***
15780 21 CFR 111.415 2 Fill, assemble, package, label - master record  You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically, ***
15786 21 CFR 111.410(b) 2 Labels - issuance, use  You did not control the [issuance] [use] of labels, Specifically, ***
15796 21 CFR 111.430(b) 2 Records - packaging, labeling operations  You did not make and keep records of the written procedures for [packaging] [labeling] operations.  Specifically, ***
15799 21 CFR 111.560(a)(1) 2 Product complaint - quality control review  A qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements.  Specifically, ***
15809 21 CFR 111.570(b)(1)   2 Written procedures - product complaint; review, investigate  You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.  Specifically, ***
15811 21 CFR 111.570(b)(2)(i)  2 Record - person document; time of performance The person who performed a requirement relating to product complaints did not document, at the time of performance, that the requirement was performed.   Specifically, ***
15817 21 CFR 111.570(b)(2)(ii)(F) 2 Record - product complaint; findings  The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken].  Specifically, ***
15828 21 CFR 111.70(a)  2 Specifications - manufacturing process  You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is packaged and labeled as specified in the master manufacturing record].  Specifically, ***
15831 21 CFR 111.70(b)(3) 2 Specifications - contamination limits  You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, ***
15838 21 CFR 111.70(d) 2 Specifications - labels, packaging You did not establish [label] [packaging] specifications.  Specifically, ***
15840 21 CFR 111.70(e) 2 Specifications -  contamination limits  You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.  Specifically, ***
15841 21 CFR 111.70(f) 2 Specifications - product received for packaging, labeling  You did not establish specifications to [sufficiently] assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order.  Specifically, 
15868 21 CFR 111.75(b)(2) 2 Specifications met - deviation, unanticipated occurrence  You did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated occurrence that may result in a failure to meet specifications.  Specifically, ***
15870 21 CFR 111.75(c)(1) 2 Specifications met - verify; production, process control  You did not select one or more established specifications for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement] that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications.  Specifically, ***
15871 21 CFR 111.75(c)(2) 2 Specifications met - test, examinations; compliance  You did not conduct appropriate tests or examinations to determine compliance with the specifications established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].  Specifically, ***
15875 21 CFR 111.75(d)(1) 2 Documentation specifications met; exempted, periodic testing You did not document why an exempted product specification is met without verification by periodically testing the finished batch.  Specifically, ***
15882 21 CFR 111.75(h)(2)  2 Tests, examinations - scientifically valid  You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.  Specifically, ***
15891 21 CFR 111.80(a) 2 Components packaging, labels received You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you received from a supplier to determine whether the [components] [packaging] [labels] meet[s] established specifications.  Specifically, ***
15899 21 CFR 111.83(b)(1)  2 Reserve sample container-closure contamination,deterioration Your reserve sample of a dietary supplement that was distributed to be  packaged and labeled was not held using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it was distributed for packaging and labeling elsewhere.  Specifically, ***
15932 21 CFR 111.105(a)   2 Processes, specifications, written procedures Your quality control personnel did not approve or reject [processes] [specifications] [written procedures] [controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength, or composition of a dietary supplement.  Specifically, ***
15933 21 CFR 111.105(b)   2 Quality control - supplier qualification Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers.  Specifically, ***
15939 21 CFR 111.105(g) 2 Quality control - reserve samples Your quality control personnel did not ensure that required reserve samples were collected and held.  Specifically, ***
15967 21 CFR 111.117(b)   2 Quality control operations - calibration records Your quality control operations did not include periodically reviewing all records for calibration of instruments and controls.  Specifically, ***
15972 21 CFR 111.120(b) 2 QC operations -specifications; components, packaging, labels Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications.  Specifically,  ***
15989 21 CFR 111.127 2 Quality control operations - packaging, labeling You do not have quality control operations for [packaging] [labeling].  Specifically, ***
15999 21 CFR 111.127(h) 2 QC operations - packaging, labeling; approving, rejecting Your quality control operations for packaging and labeling did not include approving for release, or rejecting, any packaged and labeled dietary supplement.  Specifically, ***
16051 21 CFR 111.525(b) 2 Returned dietary supplement - release  Your quality control personnel did not approve or reject the release for distribution of a returned dietary supplement that was reprocessed.  Specifically, ***
16058 21 CFR 111.535(b)(2) 2 Records - ret'nd dietary supplement: material review, dispos You did not make and keep records of a material review and disposition decision on a returned dietary supplement. Specifically, ***
16072 21 CFR 111.35(b)(3) 2 Instruments, controls; calibrate date, reference std, method Your calibration documentation did not [identify the instrument or control calibrated] [provide the date of calibration] [identify the reference standard used] [include the certification of accuracy of the known reference standard] [include a history of recertification of accuracy of a known reference standard] [identify the calibration method used] [include appropriate limits for accuracy and precision] [provide the calibration reading or readings found] [identify the recalibration method used] [identify the reading or readings of recalibration found if the accuracy or precision limits were not met] [include the initials of the person who performed the calibration or recalibration].  Specifically, ***
16089 FDCA 417(d)(1)(A) 2 Reportable food report - submission You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food.  Specifically, ***
930 21 CFR 123.8(c) 1 Verification - hazard analysis reassessment In the absence of a HACCP plan, you did not reassess the adequacy of your hazard analysis after changes were made to the product or the process that could reasonably affect whether a food safety hazard now exists.  Specifically, ***
948 21 CFR 123.12(b) 1 Competent third party The third party hired to assist with or perform some or all of your importer verification activities lacks the qualifications to perform those activities.  Specifically, ***
1245 21 CFR 113.81(a) 1 Raw ingredients There was no means to assure that raw materials and ingredients susceptible to microbiological contamination were suitable for use in processing low-acid food.  Specifically, ***
1258 21 CFR 113.60(c) 1 Coding - visible Hermetically sealed containers do not have an identifying code permanently visible to the naked eye.  Specifically ***
1260 21 CFR 129.20(a) 1 Conveyor openings minimal Conveyor openings in the bottling room exceed the size required to permit passage of containers. Specifically, ***
1273 21 CFR 129.20(b) 1 Non-sealed system You do not conduct processing operations in a sealed system under pressure, and you do not provide [adequate] protection against contamination of the water and the system.  Specifically, ***
1276 21 CFR 129.20(c) 1 Adequate ventilation The ventilation in the [processing room] [bottling room] [container washing and sanitizing area] is not adequate to minimize condensation.  Specifically, ***
1300 21 CFR 113.81(c) 1 Fill The filling of containers is not controlled to ensure that the filling requirements specified in the scheduled process are met.  Specifically, ***
1301 21 CFR 113.81(d) 1 Exhausting The exhausting of containers for removal of air is not controlled to meet the conditions for which the process was designed.  Specifically, ***
1302 21 CFR 113.81(e) 1 pH The equilibrium pH of the finished product is not controlled so as to meet the pH requirements in the scheduled process.  Specifically, ***
1304 21 CFR 129.35(a)(1) 1 Product water quality The product water supply source is not [properly located, protected and operated] [easily accessible] [adequate] [of a safe, sanitary quality] [in conformance at all times with the applicable laws and regulations].  Specifically, ***
1317 21 CFR 113.87(d) 1 Timing devices Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved.  Specifically, ***
1320 21 CFR 113.87(g) 1 Bleeder mufflers Failure to keep on file evidence that mufflers on [bleeders] [the vent system] are operating in a manner that does not impede the removal of air .  Specifically, ***
1324 21 CFR 113.100(d) 1 Distribution record Distribution records are not maintained to identify the initial distribution of the finished product.  Specifically, ***
1359 21 CFR 129.35(a)(3)(i) 1 Maintaining sample & analysis records You do not maintain records on file at the plant pertaining to [approval of the source water by government agencies] [sampling and analyses for which you are responsible].  Specifically, ***
1381 21 CFR 129.35(b) 1 Free of oil, dust, rust, etc. Air under pressure that is directed at [product water] [a product water-contact surface] is not free of [oil] [dust] [rust] [excessive moisture] [extraneous materials].  Specifically, ***
1401 21 CFR 129.37(a) 1 Inspection for sanitary condition You do not inspect all product water-contact surfaces as often as necessary [to maintain the sanitary condition of such surfaces] [to assure such surfaces are kept free of scale, evidence of oxidation, and other residue].  Specifically, ***
1417 21 CFR 129.37(c) 1 Exam, handling of single service containers et. al. Single service [containers] [caps] [seals] are not [examined] [washed, rinsed and sanitized when necessary] [handled in a sanitary manner] prior to use.  Specifically, ***
1453 21 CFR 129.40(a)(1) 1 Suitability - equipment and utensils Not all plant equipment and utensils are suitable for their intended use.  Specifically, ***
1467 21 CFR 129.40(a)(2) 1 Suitability - contact surfaces Not all material used for product water contact surfaces [is nontoxic and nonabsorbent] [can be adequately cleaned and sanitized] [is in compliance with section 409 of the Federal Food, Drug and Cosmetic Act].  Specifically, ***
1472 21 CFR 113.83 1 Critical factors not stated Critical factors that may affect the scheduled process are not specified in the scheduled  process.  Specifically, ***
1474 21 CFR 113.83 1 Calculations not performed Calculations used to determine heat sterilization processes were not performed according to procedures recognized by competent processing authorities.  Specifically, ***
1475 21 CFR 113.83 1 Incubation tests - number of commercial runs (S) Incubation tests for confirmation of the scheduled process did not include containers from each of four or more actual commercial production runs.  Specifically, ***
1485 21 CFR 113.87(a) 1 Scheduled processes not available Scheduled processes were not readily available to the [retort or processing system supervisor] [FDA Investigator].  Specifically, ***
1486 21 CFR 113.87(b) 1 System not established A system of traffic control to prevent unretorted product from bypassing the retort system has not been established.  Specifically, ***
1501 21 CFR 113.89 1 Evaluation records No records were made of the [procedures] [results] of the evaluation done by a process authority following a deviation from the scheduled process.  Specifically, ***
1502 21 CFR 113.89 1 Failure to reprocess or destroy product found underprocessed Failure to fully reprocess or destroy product determined by a competent processing authority not to have received a thermal process sufficient to render it free of microorganisms of potential public health significance.  Specifically, ***
1532 21 CFR 113.100(a)(7) 1 Other systems Forms used in recording specific processing and production information for other systems lack critical factors specified in the formulation of the product or in the scheduled process.  Specifically, ***
1563 21 CFR 110.35(d)(1) 1 Low-moisture food requirements Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use.  Specifically, ***
1569 21 CFR 110.35(d)(2) 1 Continuous operations Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary.  Specifically, ***
1649 21 CFR 113.40(a)(1) 1 Scale and range The mercury-in-glass thermometer [had divisions not readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale].  Specifically, ***
1653 21 CFR 113.40(a)(1) 1 Unreadable MIG thermometer Mercury-in-glass thermometers were not installed where they can be accurately and easily read.  Specifically, ***
1691 21 CFR 113.40(a)(4) 1 Steam controller Failure to equip retorts with automatic steam controllers to maintain retort temperatures.  Specifically, ***
1732 21 CFR 113.40(a)(2) 1 Range Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature.  Specifically, ***
1740 21 CFR 113.40(a)(2) 1 Well bleeder Failure to have a 1/16-inch or larger bleeder.  Specifically, ***
2057 21 CFR 123.28(c) 1 Harvest licensure You do not have controls to ensure that the shellstock you receive [is from a harvester that is in compliance with licensure requirements or from a processor certified by a shellfish control authority] [has a tag affixed to each container or is accompanied by a bill of lading or similar document with specific information]. Specifically, ***
2058 21 CFR 123.28(c) 1 Tag requirements - shellstock The tags attached to each container of shellstock you receive do not [always] bear [the place and date the shellfish were harvested] [the type and quantity of shellfish] [an identification of the harvester].  Specifically, ***
2059 21 CFR 123.28(d) 1 Labels - shucked shellfish You do not have controls in place to ensure that shucked molluscan shellfish are in containers that bear a label that discloses [the date and place they were harvested] [the type and quantity of shellfish] [by whom they were harvested].  Specifically, ***
2065 21 CFR 123.28(c) 1 Shellstock records You do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification number of the harvester issued by the shellfish control authority].  Specifically, ***
2067 21 CFR 123.28(d) 1 Records - shucked shellfish You do not maintain records of shucked molluscan shellfish that document the [date of receipt] [quantity and type of shellfish] [name and certification number of the packer or repacker of the product].  Specifically, ***
2101 21 CFR 113.40(a)(13) 1 Measured, recorded Critical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors are within limits specified  in the scheduled process.  Specifically, ***
2103 21 CFR 113.40(a)(13)(ii) 1 Closing vacuum Closing machine vacuum is not [observed] [recorded] at intervals of sufficient frequency to ensure that the vacuum is as specified  in the scheduled process.  Specifically, ***
2143 21 CFR 113.40(b)(1) 1 Scale and range A mercury-in-glass thermometer [lacked divisions readable to 1 degree F] [had a temperature range that exceeded 17 degrees per inch of graduated scale].  Specifically, ***
2144 21 CFR 113.40(b)(1) 1 Thermometer calibration Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [at least once a year] [as frequently as necessary].  Specifically, ***
2149 21 CFR 113.40(b)(1) 1 Not used as reference A mercury-in-glass thermometer was not the reference instrument used for indicating processing temperatures.   Specifically, ***
2151 21 CFR 113.40(b)(2) 1 Range Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature.  Specifically, ***
2167 21 CFR 113.40(b)(9) 1 No indicator There is no means to determine the water level in a retort during operations.  Specifically, ***
2169 21 CFR 113.40(b)(9) 1 Operator check and recording The operator failed to [check] [record] the water level at intervals sufficient to ensure adequacy of the water level.  Specifically, ***
2221 21 CFR 113.40(b)(10)(i) 1 Check valve There is no check valve provided in the air supply line to prevent water from entering the air supply line.  Specifically, ***
2275 21 CFR 129.80(g)(2) 1 Chemical, physical, radiological You do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological] testing at least annually [for each type of bottled drinking water produced during a day's production run].  Specifically, ***
2285 21 CFR 129.80(f) 1 Reject / reprocess You did not reject or reprocess containers that were not [sound] [properly capped or sealed] [properly coded and labeled].  Specifically, ***
2309 21 CFR 113.40(c)(1) 1 Unreadable thermometer Mercury-in-glass thermometers were not installed where they can be accurately and easily read.  Specifically, ***
2329 21 CFR 113.40(c)(5) 1 Size, fully open Bleeders are [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time].  Specifically, ***
2336 21 CFR 113.40(c)(5) 1 Condensate bleeder The condensate bleeder was not checked with sufficient frequency to ensure removal of condensate or equipped with an automatic alarm system for the continuous monitoring of condensate bleeder functioning.  Specifically, ***
2390 21 CFR 110.80(a)(6) 1 Kept frozen prior to use Failure to keep frozen raw materials frozen prior to use.  Specifically, ***
2428 21 CFR 110.80(b)(9) 1 Proper reconditioning Failure to use a proven effective method of reconditioning adulterated food.  Specifically, ***
2499 21 CFR 113.40(e)(2) 1 Presence and accuracy Each retort did not have an accurate temperature-recording device.  Specifically, ***
2513 21 CFR 113.40(e)(7) 1 Measured and recorded Critical factors were not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process.  Specifically, ***
2526 21 CFR 113.40(f)(1) 1 No MIG thermometer Each retort did not have a mercury-in glass thermometer (MIG).   Specifically ***
2843 21 CFR 113.40(g)(1)(i)(a) 1 Not used as reference The temperature-indicating device was not used as the reference instrument for indicating  processing temperatures.  Specifically, ***
2849 21 CFR 113.40(g)(1)(i)(b) 1 Unauthorized adjustment There is no means of preventing unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
2864 21 CFR 113.40(g)(1)(ii)(b) 1 Process deviations per 113.89 Process deviations are not handled in accordance with 21 CFR 113.89.  Specifically, ***
2886 21 CFR 113.40(i) 1 Inadequate instruments The time and temperature of processing and other critical factors specified in the scheduled process were not measured with instruments having adequate accuracy or dependability.  Specifically, ***
2888 21 CFR 113.40(j) 1 Critical factors Critical factors are not [measured] [recorded] at intervals of sufficient frequency to ensure that the factors are within limits specified in the scheduled process.  Specifically, ***
2889 21 CFR 113.40(g)(2)(i)(a) 1 Instrumentation The [container and closure sterilization system]  [product filling and closing system] was not instrumented to demonstrate that required sterilization is being accomplished continuously.  Specifically, ***
2890 21 CFR 113.40(g)(2)(i)(a) 1 Automatic recording devices Automatic recording devices  were not used to record [sterilization media flow rates] [temperature] [concentration] [factors specified in the scheduled process] for container sterilizing, filling, and closing operations.   Specifically, ***
2896 21 CFR 113.40(g)(2)(ii)(b) 1 Process deviations per 113.89 Product packaged below scheduled process specifications was not [segregated] [handled in accordance with 21 CFR 113.89].  Specifically, ***
2898 21 CFR 113.40(g)(2)(ii)(c) 1 Sufficient frequency Observations and measurements of operating conditions were not [made] [recorded] at intervals of sufficient frequency to ensure commercial sterility.  Specifically, ***
2899 21 CFR 113.40(g)(2)(ii)(c) 1 Required information Observations and measurements of operating conditions did not include [sterilization media flow rates] [temperatures] [container and closure rates through the sterilizing system] [batch container sterilization conditions].  Specifically, ***
3649 21 CFR 110.35(d)(1) 1 Dry and sanitary Failure to keep food-contact surfaces used in the [manufacture] [holding] of low-moisture food in a dry, sanitary condition at the time of use.  Specifically, ***
3708 21 CFR 110.80(a)(1) 1 Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].  Specifically, ***
3711 21 CFR 110.80(b)(17) 1 Non-human foods or inedible products (S) Manufacture of [animal feed] [inedible product] in [areas] [equipment] used for manufacture of human food, where there is a reasonable possibility of contamination of human food.  Specifically, ***
3771 21 CFR 113.40(a)(7) 1 Location of steam spreader perforations (S) Perforations in the steam spreader along the bottom of the retort  are not located along the top 90 degrees of the steam spreader.  Specifically, ***
3801 21 CFR 113.40(b)(1) 1 Date last tested for accuracy (S) Failure to provide a tag, seal, or other means of identity, including the date of last calibration of the mercury-in-glass thermometer.  Specifically, ***
3804 21 CFR 113.40(a)(2) 1 Air filtration for temperature controllers (S) Failure to have adequate filter systems to ensure a supply of clean, dry air to air-operated temperature controllers.  Specifically, ***
3856 21 CFR 113.60(a) 1 Visual Failure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of a can randomly selected from each seaming head] [the closure of a typical container].  Specifically ***
3860 21 CFR 113.60(a) 1 Pertinent observations Failure to record all pertinent visual closure observations.  Specifically, ***
3863 21 CFR 113.60(a)(1) 1 Frequency of teardown examinations (S) Teardown examinations of double seam cans (and recording of the results) were performed at intervals exceeding four hours.  Specifically, ***
3864 21 CFR 113.60(a)(1) 1 Recording of teardown examinations Failure to record teardown examinations of double seam cans [at intervals of sufficient frequency] [on enough containers from each seaming station] to ensure maintenance of seam integrity.  Specifically, ***
4067 21 CFR 113.40(a)(12)(iii) 1 Venting, other installations Failure to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, for retort installations which deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)] [113.40(a)(12)(ii)(b)].  Specifically, ***
4178 21 CFR 113.83 1 Commercial production variations Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process.  Specifically, ***
4180 21 CFR 113.87(b) 1 Record of visual checks (S) Failure to make a written record of the visual checks of heat sensitive indicators.  Specifically, ***
4419 21 CFR 110.10(c) 1 Level of competency (S) Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a needed level of competency.  Specifically, ***
4512 21 CFR 108.25(g) 1 Record retention Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three years all records [of processing] [of deviations in processing] [specified in 21 CFR 114]. Specifically, ***
4514 21 CFR 108.35(c)(1) 1 Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of low-acid canned foods. Specifically, ***
4517 21 CFR 108.35(c)(2)(ii) 1 Process change substantiation Failure to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process, where the change is basic to the adequacy of that scheduled process.  Specifically, ***
4526 21 CFR 108.35(h) 1 Record inspection and copying Failure to permit [inspection] [copying] of records [of processing] [of deviations in processing] [of container closure inspections] [specified in 21 CFR 113], upon written demand by FDA, to verify the adequacy of processing, the integrity of container closure and the coding of the product. Specifically, ***
4528 21 CFR 108.35(c)(2)(ii) 1 Process change recording For an intentional change in a previously filed scheduled process, substantiation was not [promptly recorded] [verified in writing by the authority] [placed in your files for review by FDA].  Specifically, ***
4529 21 CFR 108.35(c)(2)(ii) 1 Process change reporting to CFSAN For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, within 30 days after first use, [a complete description of the modifications made and utilized] [a copy of the file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process].  Specifically, ***
6003 21 CFR 123.28(b) 1 Harvest controls You do not ensure that raw molluscan shellfish being processed are obtained from growing waters approved for harvesting by a shellfish control authority.  Specifically***
6023 21 CFR 123.28(c) 1 Bulk shellstock - harvest information The bulk shipments of shellstock you receive are not [always] accompanied by a bill of lading or similar document that identifies [the date and place the shellfish were harvested] [the type and quantity of shellfish] [by whom the shellfish were harvested].  Specifically, ***
9792 21 CFR 106.30(b)(3) 1 Stability analysis Failure to conduct stability analysis on representative samples of finished product batches.  Specifically, ***
9799 21 CFR 106.100(d) 1 Premix supplier Failure to maintain records of the results of all testing conducted to provide certificates and guarantees concerning nutrient premixes for infant formulas.   Specifically, ***
9832 21 CFR 107.20(c) 1  "Use by" date Failure to provide a "Use by ____" date on an infant formula label.  Specifically, ***
9933 21 CFR 120.6(b) 1 GMP correction - timely  You do not [always] correct deficiencies from good manufacturing practice in a timely manner.  Specifically, ***
9938 21 CFR 120.7(d) 1 Hazard analysis - evaluation of effect on safety (S) You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended consumer.  Specifically, ***
9949 21 CFR 120.11(b) 1 HACCP plan not modified You did not immediately modify your HACCP plan  after a validation revealed that the plan was no longer adequate.  Specifically, ***
9962 21 CFR 120.24(b) 1 Process controls - direct treatment  - not exempt Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply.  Specifically, ***
9963 21 CFR 120.24(c) 1 Process controls - exempt process, single facility You do not process and perform final product packaging in a single facility operating under current good manufacturing practices.  Specifically, ***
12701 21 CFR 129.35(a)(4)(iii) 1 Testing for disinfectants & DBPs Your [product] [operations] source water from a non-public source has been treated with a chlorine-based disinfectant or ozone, but has not been tested for residual disinfectants and disinfection by-products that are likely to result from such treatment.  Specifically, ***
12707 21 CFR 129.80(g)(3) 1 Records of analyses For analyses of bottled water, you do not maintain records of [date of sampling] [type of product] [production code] [results].  Specifically, ***
12709 21 CFR 129.80(c) 1 Records of cleaning/sanitizing solutions You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions.  Specifically, ***
12750 21 CFR 120.8(b)(6) 1 HACCP plan - valid procedures / frequency - none listed Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to ensure that the HACCP plan is adequate to control food hazards that are reasonably likely to occur.  Specifically, ***
12754 21 CFR 120.11(a)(1)(iv)(C) 1 Calibration, testing - record review adequacy Your review of [calibration of process monitoring instruments] [periodic end-product testing] [periodic in-process testing] records does not ensure that [the records are complete] [the activities occurred in accordance with your written procedures].  Specifically, ***
15301 21 CFR 120.24(b) 1 Process controls - citrus The surface treatments on your citrus fruit do not ensure a 5 log reduction in the most resistant microorganism of public health significance because [the process begins before culling and cleaning] [the fruit is not tree picked] [the 5 log pathogen reduction is not performed in a single facility].  Specifically, ***
15310 21 CFR 70.25 1 Color additive labeling Color additive was not labeled with [the name of the straight color] [the name of each ingredient comprising  the color additive] [a statement indicating general limitations for use] [the amount of each straight color in terms of weight per unit/volume or percent by weight] [an expiration date].  Specifically, ***
15322 21 CFR 74 subpart C 1 Color additives intended for use in cosmetics A color additive subject to certification intended for use in the manufacture of a cosmetic is not from a certified batch. Specifically, ***
15352 FDCA 761(b)(1) 1 No label copy submitted with AE report (dietary supplement)  Copies of labels from on or within the retail package of a dietary supplement did not accompany serious drug event report. Specifically, ***
15358 FDCA 761(c)(1) 1 Timing of AE report submission (dietary supplement) An adverse event report for a dietary supplement was not submitted to the Secretary of HHS within 15 business days of receipt of the report,. Specifically, ***
15381 21 CFR 111.8 1 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices.  Specifically, ***
15388 21 CFR 111.10(b) 1 Personnel - hygienic practices Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.  Specifically, ***
15389 21 CFR 111.10(b)(1) 1 Outer garments Your personnel did not wear outer garments in a manner that protects against contamination of components, dietary supplements or contact surfaces.  Specifically, ***
15393 21 CFR 111.10(b)(4) 1 Hand jewelry - remove Your personnel did not remove hand jewelry that cannot be adequately sanitized during periods in which components or  dietary supplements are manipulated by hand.  Specifically, ***
15395 21 CFR 111.10(b)(5) 1 Gloves Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material].  Specifically, ***
15396 21 CFR 111.10(b)(6) 1 Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, ***
15411 21 CFR 111.14(b)(2) 1 Personnel - records - training date, type, persons Your training documentation did not include the [date of the training] [type of training] [persons trained].  Specifically, ***
15423 21 CFR 111.15(j) 1 Trash disposal You did not convey, store, and dispose of trash to [minimize development of odors] [minimize potential for the trash to attract, harbor, or become a breeding place for pests] [protect against contamination of components, dietary supplements, contact surfaces, water supplies, and grounds surrounding your physical plant] [control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces].  Specifically, ***
15431 21 CFR 111.15(e)(1) 1 Water supply - not component - suitability Water that does not become a component of the dietary supplement was not [safe and sanitary] [at suitable temperature] [under appropriate pressure] for all uses.  Specifically, ***
15433 21 CFR 111.15(d)(1) 1 Animals and pests in facility You allowed [animals] [pests] in your physical plant. Specifically, ***
15444 21 CFR 111.15(c)(1) 1 Cleaning compounds You did not use cleaning compounds that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use].  Specifically, ***
15447 21 CFR 111.15(c)(3) 1 Cleaning compounds and toxic materials - holding You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.  Specifically, ***
15452 21 CFR 111.15(f)(5) 1 Plumbing - backflow, cross connection The plumbing in your physical plant allows [backflow from] [cross connection between] piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.  Specifically, ***
15468 21 CFR 111.20(c)(2) 1 Physical plant - material review and disposition You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplements by separating components, dietary supplements, packaging, and labels that are to be used in manufacturing from those that are awaiting material review and disposition decision, reprocessing, or disposal.  Specifically, *** 
15473 21 CFR 111.20(c)(7) 1 Physical plant - separate areas - holding You [did not have] [did not use] separate or defined areas of adequate size or other control systems prevent contamination or mix-ups of components or dietary supplements during holding operations.  Specifically, ***
15482 21 CFR 111.23(c) 1 Records - water You did not make and keep records that show that the water you use [complies with applicable Federal, State, and local requirements] [does not contaminate the dietary supplement].  Specifically, ***
15493 21 CFR 111.25(b) 1 Procedures - calibrating automated, mechanical equip You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.  Specifically, ***
15507 21 CFR 111.27(a)(5)(i) 1 Refrigerator, freezer - temperature recording device Your freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary supplements does not have an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the accurate temperature within the compartment.  Specifically, ***
15509 21 CFR 111.27(a)(6) 1 Instruments, controls - accurate, precise, maintained You used instruments or controls that were not [accurate and precise] [adequately maintained] [adequate in number for their designated uses].  Specifically, ***
15511 21 CFR 111.27(d) 1 Equipment - maintain - general You did not [maintain] [clean] [sanitize]  equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements.  Specifically, ***
15518 21 CFR 111.27(d)(4) 1 Contact surfaces - not in direct contact - cleaning You did not clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements.  Specifically, ***
15526 21 CFR 111.30(c) 1 Equipment - automated - calibrate, inspect You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance.  Specifically, ***
15527 21 CFR 111.30(c) 1 Equipment - automated - QC check Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of your automated, mechanical, or electronic equipment.  Specifically, ***
15529 21 CFR 111.30(e) 1 Equipment - controls, intended use You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use.  Specifically, ***
15533 21 CFR 111.255(c)   1 Batch record - follow master Your batch production record did not accurately follow the appropriate master manufacturing record.  Specifically, ***
15536 21 CFR 111.255(d)   1 Batch record - originals, copies, electronic  You did not keep batch production records as original records, true copies, or as electronic records.  Specifically, ***
15542 21 CFR 111.260(b)  1 Batch record - date, time; maintenance Your batch production records did not include the identity of equipment and processing lines used in producing the batch.  Specifically, ***
15543 21 CFR 111.260(c)  1 Batch record - date, time; maintenance Your batch production records did not include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained.  Specifically, ***
15554 21 CFR 111.260(j)(2)(ii) 1 Batch record - initials; verifying weight Your batch production records did not include the initials of the person responsible for verifying the weight or measure of each component used in the batch.  Specifically, ***
15557 21 CFR 111.260(k) 1 Batch record - packaging, labeling Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations.  Specifically, ***
15559 21 CFR 111.260(k)(1) 1 Batch record - identifier; labels Your batch production records did not include [the unique identifier assigned to labels used] [the quantity of the labels used] [reconciliation of discrepancies between issuance and use of labels].  Specifically, ***
15561 21 CFR 111.260(k)(3) 1 Batch record - tests, examinations; results Your batch production records did not include the results of any tests or examinations conducted on packaged and labeled dietary supplements or a cross-reference to the physical location of such results.  Specifically, ***
15565 21 CFR 111.260(l)(2) 1 Batch record - reprocessing, repackaging Your batch production records did not include documentation that quality control personnel approved or rejected [reprocessing] [repackaging].  Specifically, ***
15566 21 CFR 111.260(l)(3) 1 Batch record - approved, released, rejected; batch Your batch production records did not include documentation that quality control personnel approved and released, or rejected, a batch for distribution.  Specifically, ***
15571 21 CFR 111.153 1 Written procedures - packaging You did not [establish] [follow] written procedures for the requirements for packaging received.  Specifically, ***
15573 21 CFR 111.153 1 Written procedures - product received; packaging, labeling You did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement.  Specifically, ***
15575 21 CFR 111.153 1 Written procedures - rejected products  You did not [establish] [follow] written procedures for the requirements for rejected products that are received for packaging or labeling as a dietary supplement.  Specifically, ***
15577 21 CFR 111.155(b) 1 Visually examine - supplier's invoice You did not visually examine the supplier's invoice, guarantee, or certification in [a shipment] [shipments] you received to ensure the components are consistent with your purchase order.  Specifically, ***
15580 21 CFR 111.155(c)(2) 1 Quality control - components; tests, examination results Your quality control personnel did not review and approve the results of [tests] [examinations] conducted on components while the components were quarantined. Specifically, ***
15583 21 CFR 111.155(d)(1) 1 Components - identify lot received You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component] [the status of the component] [the dietary supplement that you manufactured and distributed].  Specifically,  ***
15587 21 CFR 111.160(a) 1 Packaging, labels - visually examine container You did not visually examine each immediate container, or grouping of immediate containers, in a shipment for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the packaging and labels.  Specifically, ***
15588 21 CFR 111.160(b) 1 Packaging, labels - visually examine; invoice, guarantee You did not visually examine the supplier's invoice, guarantee, or certification in a shipment to ensure that the packaging or labels are consistent with your purchase order.  Specifically, ***
15589 21 CFR 111.160(c) 1 Packaging, labels - quarantine You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement.  Specifically, ***
15592 21 CFR 111.160(c)(1) 1 Packaging - visual identification; containers, closures You did not conduct a visual identification of the immediate containers and closures of packaging while the packaging was quarantined.  Specifically, ***
15597 21 CFR 111.160(c)(3) 1 Labels - quality control; approve, release Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement and release them from quarantine.  Specifically, ***
15599 21 CFR 111.160(d)(1) 1 Labels - identify You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels] [the dietary supplement that you distributed].  Specifically, ***
15602 21 CFR 111.160(e) 1 Packaging, labels - mixups  You did not hold [packaging] [labels] under conditions that will avoid mix-ups.  Specifically, ***
15607 21 CFR 111.165(c)(2) 1 Product received - quality control; documentation; specs Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.  Specifically,  ***
15608 21 CFR 111.165(c)(3) 1 Product received - quality control; approve  Your quality control personnel did not approve quarantined received product for [packaging] [labeling] as a dietary supplement. Specifically, ***
15609 21 CFR 111.165(c)(3) 1 Product received - quality control; quarantine; release  Your quality control personnel did not release received product from quarantine for [packaging] [labeling] as a dietary supplement.  Specifically, ***
15610 21 CFR 111.165(d)(1)  1 Product received - identify You did not identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the status of the received product] [the product that you packaged or labeled and distributed as a dietary supplement].  Specifically, ***
15614 21 CFR 111.170  1 Quarantine  component, package, labels, rejected product You did not clearly identify, hold, and control under a quarantine system for appropriate disposition [a component] [packaging] [labels] [product] that you received for packaging or labeling as a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations.  Specifically, ***
15618 21 CFR 111.180(b)(1) 1 Written procedures - components  You did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements.  Specifically,  ***
15623 21 CFR 111.180(b)(2) 1 Records - receiving; components, packaging, labels, products You did not make and keep receiving records for [components] [packaging] [labels] [products you received for packaging or labeling as a dietary supplement].  Specifically,  ***
15624 21 CFR 111.180(b)(3) 1 Documentation - components  You did not make and keep documentation that the requirements that apply to production and process control for components of dietary supplements were met.  Specifically, ***
15630 21 CFR 111.180(b)(3)(i) 1 Document - required operation  The person who performed a required operation did not document, at the time of performance, that the required operation was performed.  Specifically, ***
15646 21 CFR 111.460(a)  1 Hold, identify - in-process material  You did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration.  Specifically, ***
15660 21 CFR 111.475(b)(2)  1 Records - product distribution  You did not make and keep records of product distribution.  Specifically, ***
15662 21 CFR 111.303 1 Written procedures - laboratory operations  You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
15669 21 CFR 111.310(c) 1 Laboratory facilities -  dietary supplement specifications  You did not use adequate laboratory facilities to perform [testing] [examinations] necessary to determine whether your dietary supplements met specifications.  Specifically, ***
15671 21 CFR 111.315 1 Laboratory control  processes - requirements  You did not [establish] [follow] laboratory control processes.  Specifically, ***
15672 21 CFR 111.315  1 Laboratory control  processes - reviewed, approved  The laboratory control processes that you established and followed were not reviewed and approved by quality control personnel. Specifically, ***
15679 21 CFR 111.315(b)(1) 1 Laboratory control  processes - sampling plans; packaging  You did not [establish] [follow] sampling plans for obtaining representative samples of packaging.  Specifically, ***
15683 21 CFR 111.315(c) 1 Examination, testing methods; criteria for selecting You did not [establish] [follow] laboratory control processes for use of criteria for selecting appropriate examination and testing methods.  Specifically, ***
15689 21 CFR 111.315(b)(3)   1 Sampling plans; finished batches You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of dietary supplements.  Specifically,  ***
15693 21 CFR 111.315(b)(1) 1 Laboratory control  processes - sampling plans; labeling  You did not [establish] [follow] sampling plans for obtaining representative samples of labels.  Specifically, ***
15709 21 CFR 111.325(b)(2) 1 Laboratory methodology followed You did not make and keep documentation that established laboratory methodology was followed.  Specifically, ***
15728 21 CFR 111.365(d) 1 Chemical,microbiological,other test-contaminated components You did not perform chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components.  Specifically, ***
15734 21 CFR 111.360   1 Manufacturing operations - sanitation  You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, ***
15735 21 CFR 111.355 1 Manufacturing operations - design  You did not design or select manufacturing processes that ensure that product specifications are consistently met.  Specifically, ***
15743 21 CFR 111.210(h)(3)  1 Master manufacturing record - specific actions; quality  The written instructions in your master manufacturing record did not include specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.  Specifically, ***
15746 21 CFR 111.210(h)(1)   1 Instructions; specifications; quality The written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.  Specifically, ***
15749 21 CFR 111.210(e)   1 Master manufacturing record - intentional overage  Your master manufacturing record did not include a statement of intentional overage amount of a dietary ingredient.  Specifically, ***
15754 21 CFR 111.210(a) 1 Master manufacturing record - dietary ingredients  Your master manufacturing record did not include the [name] [strength] [concentration] [weight] [measure] of each dietary ingredient for each batch size.  Specifically, ***
15755 21 CFR 111.205(c) 1 Master manufacturing record:  readily available  You did not have records or copies of records required for your master manufacturing records readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, ***
15756 21 CFR 111.205(c)  1 Master manufacturing record:  electronic  Your electronic master manufacturing records do not comply with the electronic records requirements.  Specifically, ***
15760 21 CFR 111.205(b)(1) 1 Master manufacturing record-specifications; packaged, label Your master manufacturing record did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically, ***
15774 21 CFR 111.415(f)(1) 1 Batch-lot,control number packaged, labeled dietary supplemen You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement.  Specifically, ***
15784 21 CFR 111.410(c)  1 Packaging, labels - master manufacturing record  You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of dietary supplement to determine whether the [packaging] [labels] conformed to the master manufacturing record.  Specifically, ***
15785 21 CFR 111.410(b) 1 Label, packaging - discrepancies  You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].  Specifically,  ***
15787 21 CFR 111.410(b)  1 Packaging - issuance, use  You did not control the [issuance] [use] of packaging.  Specifically, ***
15800 21 CFR 111.560(a)(2) 1 Product complaint - quality control investigate  A qualified person did not investigate a product complaint that involved a possible failure of a dietary supplement to meet a specification, or other requirement.  Specifically, ***
15802 21 CFR 111.560(c)  1 Product complaint - review, investigation  Your review and investigation of a product complaint did not extend to all relevant batches and records.  Specifically, ***
15806 21 CFR 111.570(a) 1 Records - product complaints:  originals, copies, electroni You did not keep the records required for product complaints as original records, true copies, or as electronic records.  Specifically, ***
15813 21 CFR 111.570(b)(2)(ii)(B) 1 Record - product complaint; batch, lot, control number  The written record of a product complaint did not include the batch, lot, or control number of the dietary supplement.  Specifically, ***
15820 21 CFR 111.55 1 Production, process controls - packaged, labeled  You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, ***
15821 21 CFR 111.60(a) 1 Production, in- process control system - design, quality Your production and in-process control system is not designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement.  Specifically, ***
15823 21 CFR 111.60(b) 1 Production, in-process control system review, approved Your production and in-process control system was not reviewed and approved by quality control personnel.  Specifically, ***
15826 21 CFR 111.65 1 Quality control - packaged, labeled  You did not implement quality control operations to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, ***
15834 21 CFR 111.70(c)(2) 1 Specifications identity, purity strength, composition  You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for [the identity] [purity] [strength] [composition].  Specifically, ***
15843 21 CFR 111.70(g) 1 Specifications - finished packaging, labeling  You did not establish specifications [for the packaging and labeling of the finished dietary supplement] [to ensure that you used the specified packaging] [to ensure that you applied the specified label].  Specifically, ***
15845 21 CFR 111.73 1 Specifications met - quality  You did not determine whether you met specifications established to ensure the quality of the dietary supplement.  Specifically, ***
15848 21 CFR 111.73   1 Specifications met - component purity, strength, composition You did not determine whether you met established component specifications established to ensure the [purity] [strength] [composition] of dietary supplements manufactured using the components.  Specifically,  ***
15850 21 CFR 111.73  1 Specifications met  in-process purity, strength, composition You did not determine whether you met in-process specifications to ensure the [purity] [strength] [composition] of the dietary supplements.  Specifically, ***
15860 21 CFR 111.75(a)(2) 1 Component - confirm identity; specifications met  You did not confirm the identity of components.  Specifically, ***
15864 21 CFR 111.75(a)(2)(ii)(C) 1 Documentation - qualify supplier  You did not maintain documentation of how you qualified the supplier of a component.  Specifically, ***
15874 21 CFR 111.75(c)(4) 1 Documentation - specifications met; basis, quality control  Your quality control personnel did not review and approve your documentation of the basis for determining compliance with [an] established specification[s] for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].  Specifically, ***
15878 21 CFR 111.75(e)  1 Product - visually examine, identified   You did not [visually examine a product that you received for packaging or labeling] [have documentation that the product you received for packaging or labeling is adequately identified and is consistent with your purchase order].  Specifically, ***
15881 21 CFR 111.75(g)  1 Packaging, labeling - visual examination   You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label.  Specifically, ***
15885 21 CFR 111.77(a) 1 Specifications not met - reject, quality control  Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for which a specification was not met.  Specifically, ***
15894 21 CFR 111.80(d) 1 Specifications - representative samples; unique lot  You did not collect representative samples of [each unique shipment] [each unique lot within each unique shipment] product that you received for packaging or labeling as a dietary supplement to determine whether the received product meets established specifications.  Specifically, ***
15901 21 CFR 111.83(b)(3) 1 Reserve sample - retained   You did not retain reserve samples for the required time.  Specifically, ***
15903 21 CFR 111.87 1 Material review, disposition - quality control  Your quality control personnel did not [conduct required material reviews] [make required disposition decisions].  Specifically,
15908 21 CFR 111.90(b)(1) 1 Reprocessed, dietary supplement - no material review  You reprocessed a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the reprocessing].  Specifically, ***
15920 21 CFR 111.95(b)(1) 1 Records - established specifications  You did not make and keep records of established specifications.  Specifically, ***
15922 21 CFR 111.95(b)(3)   1 Documentation - ensure specifications met   You did not make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for [identity][ purity][ strength][ composition][ limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement].  Specifically, ***
15930 21 CFR 111.105 1 Ensure quality; package, labeled, master record Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding] operations ensure the quality of the dietary supplement.  Specifically, ***
15934 21 CFR 111.105(c)   1 Basis; in-process, component, specifications Your quality control personnel did not review and approve the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met.  Specifically, ***
15945 21 CFR 111.105(i)   1 QC - required operations packaging/labeling operations Your quality control personnel did not perform required operations for [packaging] [labeling] operations. Specifically, ***
15949 21 CFR 111.110(a) 1 QC-Laboratory control processes; production, process control Your quality control operations did not include reviewing and approving laboratory control processes associated with the production and process control system.  Specifically, ***
15950 21 CFR 111.110(b) 1 Quality control operations - tests, examinations Your quality control operations did not include ensuring that [tests] [examinations] required for your laboratory operations were conducted.  Specifically, ***
15954 21 CFR 111.113(a)(2)   1 QC master manufacturing record; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record. Specifically, ***
15955 21 CFR 111.113(a)(3)   1 Quality control - adulteration; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision for an unanticipated occurrence during the manufacturing operations that adulterated or may lead to adulteration of the [component] [dietary supplement] [packaging].  Specifically, ***
15963 21 CFR 111.113(b)(2)   1 Quality control - reject; specification not met Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met.  Specifically, ***
15966 21 CFR 111.117(a)   1 Quality control operations - calibrating processes Your quality control operations did not include reviewing and approving all processes for calibrating instruments and controls.  Specifically, ***
15973 21 CFR 111.120(c) 1 QC operations - material review, disposition decision Your quality control operations did not include conducting a required material review and making a required disposition decision for [components] [packaging] [labels] prior to [their] use.  Specifically, ***
15975 21 CFR 111.120(e)   1 Quality control operations - quarantine Your quality control operations did not include approving, and releasing from quarantine, all [components] [packaging] [labels] before they were used.  Specifically, ***
15977 21 CFR 111.123(a)(1)   1 QC operations - master manufacturing record, modifications Your quality control operations did not include reviewing and approving [master manufacturing records] [modifications to the master manufacturing records]. Specifically, ***
15983 21 CFR 111.123(a)(7)   1 Quality control operations - finished batch, specifications Your quality control operations did not include determining whether each finished batch conforms to established product specifications.  Specifically, ***
15995 21 CFR 111.127(d)   1 QC operations - packaged, labeled; specifications Your quality control operations did not include determining whether the finished [packaged] [labeled] dietary supplement conforms to established specifications.  Specifically, ***
16007 21 CFR 111.135 1 Quality control operations - product complaints You do not have quality control operations for product complaints.  Specifically, ***
16008 21 CFR 111.135 1 Quality control operations - product complaints; investigate Your quality control operations for product complaints did not include [reviewing and approving decisions about whether to investigate a product complaint] [reviewing and approving the findings and follow-up action of any investigation performed].  Specifically, ***
16022 21 CFR 111.140(b)(3)(iv)   1 Material review, disposition, follow-up; identification  Your documentation of your material review and disposition decision and follow-up did not include identification of the action taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence.  Specifically, ***
16025 21 CFR 111.140(b)(3)(vii)     1 material review, disposition, follow-up; signature Your documentation of your material review and disposition decision and follow-up did not include the signature [of the individual designated to perform the quality control operation] [of each qualified individual who provides information relevant to that material review and disposition decision].  Specifically, ***
16037 21 CFR 111.605  1 Records - keep: 1 year, 2 years  You did not keep required written records for 1 year past the shelf life date or for 2 years beyond the date of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
16040 21 CFR 111.610(a) 1 Records - available; FDA  You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested. Specifically, ***
16046 21 CFR 111.503  1 Written procedures returned dietary supplement investigation You did not [establish] [follow] written procedures for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement.  Specifically, ***
16053 21 CFR 111.535(a) 1 Records - returned dietary supplement:  1 year, 2 years  You did not keep the records required for returned dietary supplements for the required time period.  Specifically, ***
16060 21 CFR 111.535(b)(4) 1 Returned dietary supplement: reevaluation, determination You did not make and keep records [of documentation of the reevaluation by quality control personnel of a dietary supplement that was reprocessed] [of the determination by quality control personnel of whether the reprocessed dietary supplement met established product specifications].  Specifically, ***
16066 21 CFR 111.35(b)(1)(i)  1 Written procedures -  instruments, controls; calibrating  You did not make and keep written procedures for calibrating instruments or controls that you use in [manufacturing] [testing] a component or dietary supplement.  Specifically, ***
16068 21 CFR 111.35(b)(1)(iii) 1 Equipment, utensils; maintaining, cleaning, sanitizing  You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and utensils that are used to manufacture, package, label, or hold components or dietary supplements.  Specifically, ***
16074 21 CFR 111.35(b)(4)  1 Records - equipment; calibrations, inspections, checks  You did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, or electronic equipment.  Specifically, ***

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Devices

Center Name Cite Id Ref No Frequency Short Description Long Description
Devices 3130 21 CFR 820.100(a) 155 Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
630 21 CFR 803.17 143 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, ***
3696 21 CFR 820.100(b) 131 Lack of documentation of CAPA activities Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***  
4189 21 CFR 820.198(a) 99 General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].  Specifically, ***
546 21 CFR 820.75(a) 97 Lack of or inadequate process validation  A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, ***
14713 21 CFR 820.198(a) 85 Lack of or inadequate complaint procedures  Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,*** 
479 21 CFR 820.50 84 Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, ***
2327 21 CFR 820.22 75 Quality audits - Lack of or inadequate procedures  Procedures for quality audits have not been [adequately] established. Specifically, *** 
3415 21 CFR 820.22 73 Quality Audit/Reaudit - conducted  Quality [audits][reaudits] have not been performed.  Specifically, *** 
3172 21 CFR 820.198(c) 71 Investigation of device failures  Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, *** 
3103 21 CFR 820.30(i) 65 Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,***
2371 21 CFR 820.30(a) 64 Design control - no procedures  Procedures for design control have not been established.  Specifically,*** 
731 21 CFR 803.50(a)(1) 60 Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.  Specifically, ***
732 21 CFR 803.50(a)(2) 55 Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.  Specifically, ***
447 21 CFR 820.40 54 Lack of procedures, or not maintained   Document control procedures have not been [established] [maintained].  Specifically,*** 
3118 21 CFR 820.75(a) 54 Documentation - general Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, ***
3666 21 CFR 820.20(c) 53 Management review - Lack of or inadequate procedures  Procedures for management review have not been [adequately] established.  Specifically,*** 
3125 21 CFR 820.80(d) 51 Lack of or inadequate final acceptance procedures  Procedures for finished device acceptance have not been [adequately] established. Specifically, *** 
3282 21 CFR 820.90(a) 49 Nonconforming product,  Lack of or inadequate procedures  Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, *** 
2350 21 CFR 820.25(b) 48 Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, *** 
3159 21 CFR 820.184 47 DHR content - general The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
3160 21 CFR 820.184 45 Lack of or inadequate DHR procedures  Procedures for device history records have not been [adequately] established.  Specifically,*** 
3233 21 CFR 820.72(a) 45 Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, ***
2974 21 CFR 812.110(b) 44 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with [the signed agreement] [the investigational plan] [applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed by FDA].  Specifically, ***
2302 21 CFR 820.20(e) 43 Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,*** 
3371 21 CFR 820.198(a)(3) 43 Processing MDRs {see also 803, 804} Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report.  Specifically, ***
486 21 CFR 820.50(a) 41 Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   Specifically, ***
3669 21 CFR 820.20(c) 41 Management review - defined interval, sufficient frequency  Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency].  Specifically, *** 
3678 21 CFR 820.30(g) 41 Design Validation - Risk analysis not performed/inadequate  Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, *** 
3837 21 CFR 820.25(b) 40 Training documentation Personnel training is not documented. Specifically, ***
541 21 CFR 820.70(c) 39 Environmental control  Lack of or inadequate procedures  Procedures to control environmental conditions have not been [adequately] established.  Specifically, ***
3104 21 CFR 820.30(j) 37 Design history file The design history file [was not established] [does not demonstrate that the design was developed following the approved design plan] [does not demonstrate that the design was developed following the requirements of 21 CFR 820].  
3120 21 CFR 820.80(a) 33 Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,***
3121 21 CFR 820.80(b) 33 Receiving acceptance procedures Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
3291 21 CFR 820.100(b) 33 Procedures The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
4059 21 CFR 820.22 31 Quality Audits - defined intervals  Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether the quality system activities and results comply with quality system procedures.  Specifically, *** 
2968 21 CFR 812.100 30 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, ***
3128 21 CFR 820.90(a) 30 Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, ***
3369 21 CFR 820.198(a)(1) 30 Uniform and timely processing Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are processed in a uniform and timely manner.  Specifically, ***
3680 21 CFR 820.70(a) 29 Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established.   Specifically, *** 
14505 21 CFR 812.140(a)(3) 29 Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, ***
537 21 CFR 820.70(a) 28 Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, *** 
3101 21 CFR 820.30(g) 27 Design validation- Lack of or inadequate procedures  Procedures for design validation have not been [adequately] established.  Specifically,*** 
3331 21 CFR 820.181 27 DMR - not or inadequately maintained  A device master record has not been [adequately] maintained.  Specifically, ***
3690 21 CFR 820.100(a)(3) 27 Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.  Specifically, ***
3201 21 CFR 820.40(a) 26 Not approved or obsolete document retrieval Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
3692 21 CFR 820.100(a)(4) 26 CAPA verification/validation of corrective/preventive action Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.  Specifically, ***
419 21 CFR 820.20(b) 25 Lack of or inadequate organizational structure  The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820.  Specifically, *** 
3127 21 CFR 820.80(e) 24 Documentation Acceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately maintained as part of the device history record].  Specifically, ***
3167 21 CFR 820.198(a) 22 Complete files maintained Complete complaint files are not maintained.  Specifically, ***
4191 21 CFR 806.10(a)(1) 22 Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.  Specifically, ***
538 21 CFR 820.70(a) 21 Process control procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented].  Specifically, ***
2650 21 CFR 820.30(f) 21 Design verification - Lack of or inadequate procedures  Procedures for design verification have not been [adequately] established.  Specifically,*** 
3192 21 CFR 820.30(g) 20 Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, ***
3301 21 CFR 820.100(a)(2) 20 Investigation procedures The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3665 21 CFR 820.20(b)(3) 20 Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.  Specifically, ***
14722 21 CFR 820.40 20 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,*** 
631 21 CFR 803.17(a)(1) 19 Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective [identification] [communication] [evaluation] of events that may be subject to medical device reporting requirements.  Specifically, ***
3155 21 CFR 820.181(a) 19 DMR device specifications The device master record does not include or refer to the location of  device software specifications.  Specifically, ***
3164 21 CFR 820.184(d) 19 Acceptance records The device history record does not include [complete] acceptance records that demonstrate the device is manufactured in accordance with the device master record.  Specifically, ***
3286 21 CFR 820.90(b)(1) 19 Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established.  Specifically, ***
4057 21 CFR 820.20(a) 19 Management ensuring quality policy is understood Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.  Specifically, *** 
3108 21 CFR 820.70(e) 18 Contamination control, Lack of or inadequate procedures  Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been [adequately] established.   Specifically, *** 
3132 21 CFR 820.120 18 Lack of or inadequate procedures for labeling  Procedures to control labeling activities have not been [adequately] established. Specifically, *** 
3206 21 CFR 820.50(b) 18 Approval, inadequate purchasing data Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been [approved] [established] [adequately approved] [adequately established].  Specifically, *** 
3235 21 CFR 820.72(a) 18 Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.  Specifically, ***
3285 21 CFR 820.90(b)(2) 18 Product rework procedures, Lack of or inadequate procedures  Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, *** 
3426 21 CFR 820.50(a)(1) 18 Documenting evaluation The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, *** 
2269 21 CFR 820.20(a) 17 Quality policy and objectives  The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility.  Specifically, *** 
3299 21 CFR 820.100(a)(1) 17 Procedure for analysis of data sources The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3687 21 CFR 820.100(a)(1) 17 Analysis of data sources Appropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems.  Specifically, ***
2928 21 CFR 812.40 16 Sponsors' general responsibilities For an investigational study, [qualified investigators were not selected] [investigators were not provided with the information they need to conduct an investigation properly] [proper monitoring was not ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a significant risk study] [reviewing IRBs were not promptly informed of significant new information about an investigation] [FDA was not promptly informed of significant new information about an investigation].  Specifically, ***
3102 21 CFR 820.30(h) 16 Design transfer - Lack of or inadequate procedures   Procedures for design transfer have not been [adequately] established.  Specifically,***
3119 21 CFR 820.75(b) 16 Lack/Inad procedure-Monitoring/Control of Validated Proces   Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, ***
3168 21 CFR 820.198(a) 16 Complaints  Complaint files are not [adequately] maintained.  Specifically *** 
3250 21 CFR 820.72(b)(2) 16 Calibration documentation There is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the next calibration date] for [inspection] [measurement] [test] equipment .  Specifically, ***
3263 21 CFR 820.250(b) 16 Sampling plans  Sampling plans are not [written][based on valid statistical rationale].  Specifically, *** 
454 21 CFR 820.40(a) 15 Document review, approval by designated individual Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, ***
6800 21 CFR 807.20 15 Establishment not registered An establishment for which registration is required has not been registered.  Specifically, ***
2293 21 CFR 820.20(d) 14 Quality plan A quality plan has not been [adequately] established.  Specifically, ***
2604 21 CFR 820.30(e) 14 Design review - Lack of or inadequate procedures  Procedures for design review have not been [adequately] established.  Specifically,*** 
3427 21 CFR 820.50(a)(2) 14 Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
14712 21 CFR 820.184 14 DHR - not or inadequately maintained  A device history record has not been [adequately] maintained.  Specifically, ***
539 21 CFR 820.70(b) 13 Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, *** 
2328 21 CFR 820.22 13 Quality audits - auditor independence  Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, *** 
2557 21 CFR 820.30(c) 13 Design input - documentation  Design input requirements were not [adequately] documented.   Specifically, ***
3226 21 CFR 820.70(g)(1) 13 Maintenance schedule, Lack of or inadequate schedule  Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, *** 
3380 21 CFR 820.198(e)(6) 13 Results of investigation Records of complaint investigations do not include the [dates] [results] of the investigation.  Specifically, ***
502 21 CFR 820.60 12 Identification procedures, Lack of or inadequate procedures  Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established.  Specifically, *** 
2351 21 CFR 820.25(b) 12 Training Employees have not been adequately trained.  Specifically, ***
3170 21 CFR 820.198(b) 12 Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
3332 21 CFR 820.184(e) 12 ID label, labeling The device history record does not include the primary identification label and labeling for each device.  Specifically, ***
3686 21 CFR 820.90(b)(2) 12 Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, ***
3688 21 CFR 820.100(a)(1) 12 Analysis of data/reports from data sources Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems.  Specifically, ***
632 21 CFR 803.17(a)(2) 11 Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.  Specifically, ***
2970 21 CFR 812.100 11 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
3284 21 CFR 820.90(a) 11 Nonconforming product evaluation/investigation The [evaluation] [investigation] of nonconforming product has not been documented.  Specifically, ***
3288 21 CFR 820.90(b)(1) 11 Documentation of disposition, justification, signature There is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the signature of the individual authorizing the use of nonconforming product].  Specifically, ***
3425 21 CFR 820.50(a)(1) 11 Evaluation and Selection, Suppliers, Contractors, etc. Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.  Specifically, *** 
4058 21 CFR 820.20 11 Management responsibility Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.  Specifically, ***
4212 21 CFR 806.20(b)(4) 11 Justification for not reporting A  justification for not reporting the correction or removal action to FDA that included [conclusions] [follow-ups] [reviews] by a designated person was not included in the record.  Specifically,***
2630 21 CFR 820.30(e) 10 Design review documentation, DHF {see also 820.30(j)} The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file.  Specifically, *** 
2985 21 CFR 812.140(a)(3)(ii) 10 Investigator records of relevant observations inadequate Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the investigation] [all diagnostic test results] are not all [accurate] [complete] [current].  Specifically, ***
3021 21 CFR 812.150(a)(1) 10 Investigator report of unanticipated adverse effects A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].  Specifically, ***
3117 21 CFR 820.70(i) 10 Software validation for automated processes Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol.  Specifically, ***
3157 21 CFR 820.181(c) 10 DMR QA  procedures and specifications The device master record does not include or refer to the location of [all] quality assurance procedures and specifications.  Specifically, ***
3171 21 CFR 820.198(b) 10 Rationale documented for no investigation  Records for complaints where no investigation was made do not include required information.  Specifically *** 
3231 21 CFR 820.70(i) 10 Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented.   Specifically, *** 
3268 21 CFR 820.80(b) 10 Incoming inspection, testing, verification Incoming product was not adequately inspected or tested to verify conformance to specifications.  Specifically, ***
3270 21 CFR 820.80(c) 10 Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3303 21 CFR 820.100(a)(4) 10 Verify, validate change {see also 820.100(a)} The procedures addressing verification or validation of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3345 21 CFR 820.200(a) 10 Servicing - Lack of or inadequate procedures  Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
3375 21 CFR 820.198(e) 10 Records of complaint investigation  Records of complaint investigations do not include required information.  Specifically, *** 
3433 21 CFR 820.75(c) 10 Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
3434 21 CFR 820.75(c) 10 Documentation - review in response to changes or deviations There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations.  Specifically, ***
3689 21 CFR 820.100(a)(2) 10 Investigation Certain indicators of nonconformities are not investigated to determine the cause of the nonconformity.  Specifically, ***
4070 21 CFR 820.30(g) 10 Design validation - documentation  The results of design validation, including [identification of the design] [method(s)] [the date] [the individual(s) performing validation], were not [adequately] documented in the design history file.  Specifically, *** 
6803 21 CFR 807.20(a) 10 Devices not listed Devices for which listing is required have not been listed.  Specifically, ***
2430 21 CFR 820.30(b) 9 Adequacy of design and development plan Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
3203 21 CFR 820.40(b) 9 Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, ***
3283 21 CFR 820.90(a) 9 Specific non-conforming product procedures Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete].  Specifically, ***
3428 21 CFR 820.50(a)(3) 9 Acceptable supplier records Records of acceptable [suppliers] [contractors] [consultants] were not maintained.  Specifically, ***
3671 21 CFR 820.25(a) 9 Personnel education, background, training & experience Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, *** 
3676 21 CFR 820.30(f) 9 Design verification - documentation  The design verification results, including [identification of the design] [method(s)] [the date] [the individual(s) performing the verification], were not [adequately] documented in the design history file.  Specifically, *** 
14716 21 CFR 820.30(f) 9 Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, *** 
3123 21 CFR 820.80(c) 8 Lack of or inadequate In-process acceptance procedures  Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, *** 
3191 21 CFR 820.30(g) 8 Design validation - production units  The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, *** 
3199 21 CFR 820.40(a) 8 Document review, approval documentation  The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, ***
3207 21 CFR 820.50(b) 8 Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, ***
3232 21 CFR 820.72(a) 8 Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results].  Specifically, ***
3262 21 CFR 820.250(a) 8 Statistical techniques - Lack of or inadequate procedures  Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been [adequately] established.  Specifically,*** 
3302 21 CFR 820.100(a)(3) 8 Identifying corrective & preventive actions The procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3379 21 CFR 820.198(e)(5) 8 Nature and details of complaint Records of complaint investigations do not include the nature and details of the complaint.  Specifically, ***
3677 21 CFR 820.30(g) 8 Design validation - software validation not performed  Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, *** 
4193 21 CFR 806.10(b) 8 Time to report - 10 days A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.  Specifically, ***
812 21 CFR 803.56 7 Submission Within One Month A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted.  Specifically, ***
2429 21 CFR 820.30(b) 7 Establish the design and development plan A design and development plan has not been [established] [defined] [documented] [implemented].  Specifically, ***
2648 21 CFR 820.30(f) 7 Design verification procedures Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3139 21 CFR 820.140 7 Lack of or inadequate procedures for handling Procedures for product handling have not been [adequately] established.  Specifically,***
3149 21 CFR 820.180 7 Availability Required records [are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA] [were not made readily available for review and copying by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed up when stored in automated data processing systems].  Specifically, *** 
3328 21 CFR 820.180(b) 7 Retention period Required records are not retained for [the design and expected life of the device] [at least 2 years from the date of release of the device for commercial distribution].  Specifically, ***
3397 21 CFR 820.80(d)(2) 7 Review of data and documentation Finished devices were released for distribution before the associated data and documentation was reviewed.  Specifically, ***
3432 21 CFR 820.75(b)(2) 7 Documentation of validated process performance There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date performed] [the individual performing the process] [the major equipment used] for a validated process. Specifically, ***
7013 21 CFR 812.110(d) 7 Inadequate financial disclosure by investigator The sponsor was not supplied [sufficient financial information to allow submission of complete and accurate certification or disclosure statements] [financial disclosure updates when a relevant change occurred during the course of the study or within one year following study completion].  Specifically, ***
14507 21 CFR 812.140(a)(3)(ii) 7 Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].  Specifically, ***
2279 21 CFR 820.20(b)(2) 6 Resources Adequate resources have not been provided for performing [management activities] [work] [assessment activities] [audits].  Specifically, ***
2981 21 CFR 812.140(a)(2)(i) 6 Investigator device accountability inadequate Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt] [batch number or code mark] of the device are not all [accurate] [complete] [current].  Specifically, ***
2984 21 CFR 812.140(a)(3)(i) 6 Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current].  Specifically, ***
3173 21 CFR 820.198(d) 6 Evaluation, timeliness, identification Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***
3227 21 CFR 820.70(g)(1) 6 Activity documentation Maintenance activities, including the [date] [individuals performing those activities], have not been documented.  Specifically, ***
3309 21 CFR 820.120(b) 6 Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including [the correct expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional processing instructions] before release.  Specifically, ***
3683 21 CFR 820.70(g) 6 Equipment Installation, Placement, Specified Requirements The [appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured] [equipment used in the manufacturing process does not meet specified requirements]. Specifically, *** 
4208 21 CFR 806.20(a) 6 Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,***
14720 21 CFR 820.50(a)(3) 6 Acceptable supplier records, inadequate records  Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established. 
633 21 CFR 803.17(a)(3) 5 Lack of  System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers].  Specifically, ***
2330 21 CFR 820.22 5 Quality audit corrective action, reaudits {see also 820.100} Quality reaudits [are not adequately performed] [do not cover corrective actions for the problem areas].  Specifically, ***
2601 21 CFR 820.30(d) 5 Essential design outputs Design outputs that are essential for the proper functioning of the device were not [completely] identified.  Specifically, ***
3111 21 CFR 820.70(f) 5 Buildings Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product].  Specifically, *** 
3144 21 CFR 820.160(a) 5 Control/distribution procedures Procedures for the control and distribution of finished devices have not been [established] [defined] [documented] [complete] [implemented] to ensure that only devices approved for release are distributed.  Specifically, ***
3162 21 CFR 820.184(b) 5 Quantity manufactured The device history record does not include the quantity of devices manufactured.  Specifically, ***
3204 21 CFR 820.40(b) 5 Change records, content Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective].  Specifically, ***
3269 21 CFR 820.80(b) 5 Incoming acceptance records, documentation  Acceptance or rejection of incoming product was not documented. Specifically, ***
3304 21 CFR 820.100(a)(5) 5 Changes to correct/prevent quality problems Changes in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective].  Specifically, ***
3333 21 CFR 820.184(f) 5 Device identification, control numbers The device history record does not include [certain] [any] device identifications and control numbers used.  Specifically, ***
3370 21 CFR 820.198(a)(2) 5 Oral complaints Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all oral complaints are documented upon receipt.  Specifically, ***
3396 21 CFR 820.80(d)(1) 5 DMR required activities {see also 820.181} Finished devices were released for distribution prior to completion of activities required in the Device Master Record.  Specifically, ***
3414 21 CFR 820.200(d)(6) 5 Test and inspection data Service reports do not include applicable test and/or inspection data.  Specifically, ***
3416 21 CFR 820.70(a)(1) 5 Process control instructions Process controls are not conducted in accordance with documented instructions and standard operating procedures.  Specifically, ***
3667 21 CFR 820.20(c) 5 Management review accomplishment Management reviews do not ensure that the quality system satisfies [the requirements of part 820] [your quality policy and objectives]. Specifically, ***
3682 21 CFR 820.70(d) 5 Implementing personnel procedures - health, cleanliness, per Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, ***
4192 21 CFR 806.10(a)(2) 5 Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.  Specifically, ***
6802 21 CFR 807.21(a) 5 Annual registration Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA].   Specifically, ***
7012 21 CFR 812.100 5 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, ***
14711 21 CFR 820.160(a) 5 Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,***
635 21 CFR 803.17(b)(1) 4 Info evaluated to determine if event was reportable The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.  Specifically, ***
778 21 CFR 803.52(f)(1) 4 Type of Reportable Event An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the type of reportable event.  Specifically, ***
2470 21 CFR 820.30(c) 4 Design input procedures - appropriateness Procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2910 21 CFR 812.7(a) 4 Promotion or test marketing An investigational device was [promoted] [test marketed] prior to FDA approval/clearance.  Specifically, ***
2980 21 CFR 812.140(a)(1) 4 Investigator correspondence records inadequate Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not all [accurate] [complete] [current].  Specifically, ***
2991 21 CFR 812.140(b)(1) 4 Sponsor correspondence records inadequate Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current].  Specifically, ***
3141 21 CFR 820.150(a) 4 Storage procedures to prevent mix-ups Procedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete] [implemented] to prevent mix-ups, damage, other adverse effects.  Specifically, ***
3142 21 CFR 820.150(a) 4 Storage procedures to avoid release of unsuitable product Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed.  Specifically, ***
3175 21 CFR 820.186 4 QSR content The quality system record has not been [adequately] maintained   Specifically *** 
3198 21 CFR 820.40(b) 4 Document changes, review and approval, communication  Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval] [communicated to appropriate personnel in a timely manner].  Specifically, *** 
3200 21 CFR 820.40(a) 4 Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, ***
3224 21 CFR 820.70(g)(2) 4 Periodic equipment inspection Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established.  Specifically, *** 
3236 21 CFR 820.72(b) 4 Procedures - content Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, ***
3266 21 CFR 820.86 4 Acceptance status   The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, *** 
3310 21 CFR 820.120(b) 4 DHR documentation of label release {see also 820.184} The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner.  Specifically, ***
3312 21 CFR 820.120(d) 4 Mixups Labeling and packaging operations were not controlled to prevent labeling mix-ups.  Specifically, ***
3381 21 CFR 820.198(e)(7) 4 Corrective action taken Records of complaint investigations do not include any corrective action taken.  Specifically, ***
3674 21 CFR 820.30(d) 4 Design output - documentation  Design output was not [adequately] documented before release.  Specifically, ***
3681 21 CFR 820.70(b) 4 Verification or validation of changes Changes to a [specification] [method] [process] [procedure] were not verified or validated.  Specifically, ***
3693 21 CFR 820.100(a)(5) 4 Implementing changes Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3841 21 CFR 820.90(b)(2) 4 Product rework adverse effects {see also 820.184} Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from rework upon the product.  Specifically, ***
4060 21 CFR 820.20(b)(3)(i) 4 Management representative implementing the quality system The management representative has not ensured that the quality system requirements are effectively established and maintained. Specifically, ***
4071 21 CFR 820.30(i) 4 Design changes - validation vs. verification Procedures were not [established] [defined] [documented] [completed] to address when verification of design changes is sufficient in lieu of validation prior to their implementation.  Specifically, ***
7006 21 CFR 812.43(c)(5) 4 No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study].  Specifically, ***
14710 21 CFR 820.150 4 Lack of or inadequate procedures for storage.  Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,*** 
14718 21 CFR 820.30(g) 4 Design validation - Risk analysis  Results of the design risk analysis were not [adequately] documented.  Specifically, ***
14721 21 CFR 820.70(g)(2) 4 Periodic equipment inspections  Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented].  Specifically, *** 
636 21 CFR 803.17(b)(2) 3 Reports and information documentation The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers].  Specifically, ***
738 21 CFR 803.52(a)(1) 3 Patient Name or Other Identifier An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient name or other identifier.  Specifically, ***
2339 21 CFR 820.22 3 Quality audit documentation The dates of quality [audits][reaudits] have not been documented.  Specifically, *** 
2403 21 CFR 820.25(a) 3 Sufficient personnel Insufficient personnel to assure that all procedures are appropriately carried out as required by the quality system.  Specifically, ***
2431 21 CFR 820.30(b) 3 Design plans- updated  Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, *** 
2649 21 CFR 820.30(f) 3 Design verification acceptance criteria Acceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities.  Specifically, ***
2916 21 CFR 812.7(d) 3 Investigational device represented as safe and /or effective An investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically, ***
2949 21 CFR 812.46(a) 3 Sponsor securing investigator compliance An investigator was not complying with the [signed agreement] [investigational plan] [requirements of the regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator was not promptly secured] [shipments of the investigational device to the investigator were not discontinued] [the investigator's participation in the investigation was not terminated].  Specifically, ***
2973 21 CFR 812.110(a) 3 Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
2993 21 CFR 812.140(b)(2) 3 Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current].  Specifically, ***
3113 21 CFR 820.70(g) 3 Design and installation Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, *** 
3115 21 CFR 820.70(h) 3 Use and removal, Lack of or inadequate procedures  Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, *** 
3156 21 CFR 820.181(b) 3 DMR production process specifications The device master record does not include or refer to the location of [all] production and process specifications.  Specifically, ***
3161 21 CFR 820.184(a) 3 DHR content - manufacturing dates The device history record does not include manufacturing dates.  Specifically, ***
3163 21 CFR 820.184(c) 3 Quantity released The device history record does not include the quantity of devices released for distribution.  Specifically, ***
3190 21 CFR 820.30(g) 3 Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, ***
3193 21 CFR 820.30(g) 3 Design validation - production units in use conditions The design was not validated under actual or simulated use conditions.  Specifically, *** 
3218 21 CFR 820.70(c) 3 Environmental control system-documentation/review inspection Inspections of environmental control system were not [documented] [reviewed]. Specifically, ***
3241 21 CFR 820.72(b)(1) 3 Calibration standard traceability A calibration standard used for [inspection] [measurement] [test] equipment is not traceable to national or international standards nor is it an independent reproducible standard.  Specifically, ***
3264 21 CFR 820.250(b) 3 Sampling methods - Lack of or inadequate procedures  Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,***
3290 21 CFR 820.90(b)(2) 3 Retesting and reevaluation of reworked product Rework of nonconforming product did not include [complete] retesting and reevaluation to ensure that the reworked product met current approved specifications.  Specifically, ***
3300 21 CFR 820.100(a)(1) 3 Statistical methodology Corrective and preventive action procedures addressing the use of appropriate statistical methodology to identify existing and potential causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3372 21 CFR 820.198(d) 3 Records of MDR Investigation  Investigation records of MDR reportable complaints do not include required information.  Specifically *** 
3398 21 CFR 820.80(d)(3) 3 No release signature Finished devices were released for distribution without signature of the individual designated to authorize such release.  Specifically, ***
3668 21 CFR 820.20(c) 3 Management review dates The results and/or dates of management reviews are not documented. Specifically, ***
3675 21 CFR 820.30(f) 3 Design verification - unresolved discrepancies Unresolved discrepancies were noted at the completion of the design verification.  Specifically, ***
3694 21 CFR 820.100(a)(6) 3 Dissemination of problem information Information related to quality problems or nonconforming product is not disseminated to those directly responsible for assuring the [quality of the product] [prevention of the quality problem].  Specifically, ***
3699 21 CFR 820.160(b) 3 Distribution records  Distribution records [were not maintained] [do not include or refer to the location of required information].  Specifically, ***
3702 21 CFR 820.250(a) 3 Appropriateness There is no information to support the appropriateness of the statistical techniques used.  Specifically, ***
3838 21 CFR 820.40(a) 3 Document review procedures, designated individual The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance. Specifically, ***
4169 21 CFR 820.100(a)(7) 3 Identifying relevant info for management review Procedures addressing identification of relevant information to be submitted for management review were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
14508 21 CFR 812.140(a)(4) 3 Investigator record of protocol deviations inadequate Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current].  Specifically,***
14523 21 CFR 812.43(c) 3 No investigator agreement A signed investigator agreement was not obtained from each participating investigator .  Specifically,***
14717 21 CFR 820.30(g) 3 Design validation - software validation documentation  Results of the validation of the device software were not [adequately] documented.  Specifically, ***
640 21 CFR 803.18(a) 2 Event files--failure to establish MDR event files have not been established and maintained.  Specifically, ***
642 21 CFR 803.18(b)(1)(i) 2 Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.  Specifically, ***
733 21 CFR 803.50(b)(1) 2 Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, ***
735 21 CFR 803.50(b)(2) 2 Explanation of Incomplete Information An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information.  Specifically, ***
783 21 CFR 803.52(f)(6) 2 Evaluation Codes An individual medical device manufacturer report submitted per FDA Form 3500A did not include in Block H the evaluation codes (including event codes, method of evaluation, result and conclusion codes).  Specifically, ***
2270 21 CFR 820.20(a) 2 Implement quality policy Not all employees [know there is] [understand] [fully implement] the quality policy. Specifically, ***
2481 21 CFR 820.30(c) 2 Design input procedures - addressing conflicting requirement Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2598 21 CFR 820.30(d) 2 Design output procedures Procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2627 21 CFR 820.30(e) 2 Design reviews performed following schedule Design reviews were not performed at appropriate times, following the review schedule.  Specifically, ***
2628 21 CFR 820.30(e) 2 Design review procedures - personnel Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct responsibility for the design stage being reviewed] [any specialists needed].  Specifically, ***
2935 21 CFR 812.43(b) 2 Sponsor shipped devices to unqualified person(s) Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation.  Specifically, ***
2972 21 CFR 812.110(a) 2 Informed consent obtained prior to study approval Written informed consent of potential subjects to participate in an investigation was obtained prior to obtaining [IRB] [FDA] approval to conduct the investigation.  Specifically, ***
2975 21 CFR 812.110(c) 2 Investigator did not supervise use of investigational device An investigational device was used for subjects not under the supervision of an authorized investigator.  Specifically, ***
3007 21 CFR 812.140(d) 2 Record retention inadequate Required records were not all maintained [during the investigation] [for a period of two years after the date on which an investigation was terminated or completed] [for a period of two years after the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol].  Specifically, ***
3023 21 CFR 812.150(a)(2) 2 Investigator report of IRB withdrawal of approval A report of the withdrawal of approval by the reviewing IRB was not prepared and submitted to the sponsor [within five working days].  Specifically, ***
3025 21 CFR 812.150(a)(3) 2 No investigator progress reports Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, ***
3027 21 CFR 812.150(a)(4) 2 Investigator non-emergency safety or soundness changes In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] .  Specifically, ***
3064 21 CFR 812.140(a)(4) 2 Investigator protocol records inadequate Copies maintained of the study protocol are not all [accurate] [complete] [current].  Specifically, ***
3109 21 CFR 820.70(d) 2 Personnel procedures-health, cleanliness, personal practices Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing].  Specifically, *** 
3138 21 CFR 820.130 2 Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.  Specifically, *** 
3151 21 CFR 820.180 2 Legibility Required records are not legible. Specifically, ***
3195 21 CFR 820.30(g) 2 Design validation unresolved discrepancies Unresolved discrepancies were noted at the completion of the design validation.  Specifically, ***
3237 21 CFR 820.72(b) 2 Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, [no] [inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any adverse effect on the device's quality].  Specifically, ***
3313 21 CFR 820.120(d) 2 Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.  Specifically, ***
3325 21 CFR 820.180 2 Storage Required records [are not stored so as to minimize deterioration and prevent loss] [that are stored in automated data processing systems are not backed up].  Specifically, ***
3330 21 CFR 820.181(d) 2 DMR packaging and labeling specifications The device master record does not include or refer to the location of [packaging] [labeling] procedures and specifications.  Specifically, ***
3343 21 CFR 820.198(e) 2 Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3346 21 CFR 820.200(b) 2 Statistical analysis {see also 820.100(a)(1)} Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3349 21 CFR 820.200(d) 2 No documentation Service reports were not documented. Specifically, ***
3374 21 CFR 820.198(d)(3) 2 Determination of relationship of device to event Investigation of MDR reportable complaints did not include a determination of the relationship of the device to the reported incident or adverse event.  Specifically, ***
3376 21 CFR 820.198(e)(2) 2 Date complaint received Records of complaint investigations do not include the date the complaint was received.  Specifically, ***
3377 21 CFR 820.198(e)(3) 2 Device identification and control number Records of complaint investigations do not include device identifications and control numbers used.  Specifically, ***
3382 21 CFR 820.198(e)(8) 2 Reply to complainant Records of complaint investigations do not include any reply to the complainant.  Specifically, ***
3409 21 CFR 820.200(d) 2 Service reports   Service reports [are not documented] [do not include the required information].  Specifically, *** 
3417 21 CFR 820.70(a)(2) 2 Production monitoring and control During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled.  Specifically, ***
3673 21 CFR 820.30(c) 2 Design input approval documentation The approval of design input requirements [(including the date and signature of the individual approving the requirements)] was not documented.  Specifically, ***
3697 21 CFR 820.150(a) 2 Stock rotation, assessment before release Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate.  Specifically, ***
4213 21 CFR 806.20(b)(5) 2 Records of communications A copy of all communications regarding the correction or removal action was not contained in the record.  Specifically,***
4216 21 CFR 806.30 2 Access not permitted FDA personnel were not permitted access to required records and reports for devices subject to correction and removal actions.  Specifically,***
4249 21 CFR 821.25(c) 2 Not established, maintained Written procedures for the collection, maintenance, and auditing of device tracking information were not [established] [implemented] [complete] [provided to the FDA].  Specifically,***
4430 21 CFR 803.18(d)(1) 2 Distributor responsibilities for records Device complaint records are not [established] [maintained] by the device distributor, including any relevant [incident information] [information regarding the evaluation of the allegations].  Specifically, ***
6808 21 CFR 807.26 2 Changes FDA was not notified within 30 days of changes in [individual ownership] [corporate structure] [partnership structure] [location] of your registered establishment.  Specifically, ***
9176 21 CFR 809.20(b) 2 Compliance with GMP In vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System Regulation.  Specifically, ***
540 21 CFR 820.70(b) 1 Production and process changes - failure to follow procedure Established procedures were not followed [completely] in making changes to [specifications] [methods] [processes] [procedures].  Specifically, ***
644 21 CFR 803.18(b)(1)(ii) 1 Files do not contain copies of MDR forms MDR event files do not contain copies of all MDR forms and other information related to the event that was submitted to [FDA] [the manufacturer] [the importer] [the distributor] [other entities].  Specifically, ***
650 21 CFR 803.18(e) 1 Results of evaluation not in mfr's MDR file The results of the evaluation of each event are not documented and maintained in the manufacturer's MDR event file.  Specifically, ***
658 21 CFR 803.30(a)(2) 1 Report of Serious Injury Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to the [known device manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility.  Specifically, ***
739 21 CFR 803.52(a)(2) 1 Patient Age or Date of Birth An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's age or date of birth.  Specifically, ***
740 21 CFR 803.52(a)(3) 1 Patient Gender An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's gender.  Specifically, ***
741 21 CFR 803.52(a)(4) 1 Patient Weight An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block A the patient's weight.  Specifically, ***
745 21 CFR 803.52(b)(2) 1 Death An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B that the outcome attributed to the adverse event was death.  Specifically, ***
748 21 CFR 803.52(b)(2)(iii) 1 Injury or Illness Requiring Intervention An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B the outcome attributed to the adverse event was a serious injury or illness requiring intervention to prevent permanent impairment of a body structure or function.  Specifically, ***
749 21 CFR 803.52(b)(3) 1 Date of Event An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event.  Specifically, ***
751 21 CFR 803.52(b)(5) 1 Description of the Event or Problem An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B a description of the event or problem to include [a discussion of how the device was involved] [the nature of the problem] [the patient follow-up or required treatment] [any environmental conditions that may have influenced the event].  Specifically, ***
791 21 CFR 803.52(f)(11)(iii) 1 Explanation of Required Information Not An individual medical device manufacturer report submitted per FDA Form 3500A did not include in Block H an explanation of why any required information was not provided and the steps taken to obtain such information.  Specifically, ***
796 21 CFR 803.55(a) 1 Initial Submission of Baseline Report A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model.  Specifically, ***
2276 21 CFR 820.20(b)(1) 1 Responsibility, authority and independence Employees who manage, perform, and assess work affecting quality have not been [assigned the appropriate responsibility and authority] [provided the independence and authority] to accomplish their work. Specifically, ****
2338 21 CFR 820.22 1 Quality audit/reaudit reports Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited.   Specifically, *** 
2599 21 CFR 820.30(d) 1 Acceptance criteria and essential outputs Design output procedures do not [contain or reference acceptance criteria] [ensure that essential design outputs are identified] [allow for an adequate evaluation of conformance to design input requirements].  Specifically, ***
2602 21 CFR 820.30(d) 1 Design output approval Design output was not [reviewed] [approved] before release.  Specifically, *** 
2913 21 CFR 812.7(b) 1 Commercialization An investigational device was commercialized by charging the [subjects] [investigators] a price larger than that necessary to recover costs of manufacture, research, development, and handling. Specifically, ***
2920 21 CFR 812.18(b) 1 Exporter of investigational device An investigational device was exported without obtaining FDA's approval prior to exportation and without complying with the export requirements of Section 802 of the Food, Drug, and Cosmetic Act. Specifically, ***
2924 21 CFR 812.20(a)(2) 1 Initiation of study prior to FDA IDE approval FDA approval was not obtained prior to initiation of an investigation for which an FDA-approved IDE was required.  Specifically, ***
2937 21 CFR 812.43(c)(1) 1 No curriculum vitae in investigator agreement The signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae. Specifically, ***
2940 21 CFR 812.43(c)(4)(i) 1 No investigation agreement statement of commitment A signed agreement that includes a statement of the investigator's commitment to conduct an investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations] [conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was not obtained from each participating investigator.  Specifically, ***
2946 21 CFR 812.45 1 Sponsor provide device information to investigators Not all investigators participating in the investigation were supplied with copies of the [investigational plan] [report of prior investigations of the investigational device].  Specifically, ***
2982 21 CFR 812.140(a)(2)(ii) 1 Investigator records of persons receiving devices inadequate Records of persons who [received] [used] [disposed] of each device are not all [accurate] [complete] [current]. Specifically, ***
2983 21 CFR 812.140(a)(2)(iii) 1 Investigator records of disposition of devices inadequate Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
2992 21 CFR 812.140(b)(2) 1 Sponsor device shipment records inadequate Records of shipment of an investigational device that include the [name and address of the consignee] [type and quantity of device] [date of shipment] [batch number or code mark] reports are not all [accurate] [complete] [current]. Specifically, ***
2994 21 CFR 812.140(b)(3) 1 Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
3003 21 CFR 812.140(b)(6) 1 Other sponsor records required by FDA inadequate Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, ***
3032 21 CFR 812.150(a)(5) 1 Investigator report for lack of informed consent A report to the [sponsor] [reviewing IRB] regarding the use of an investigational device without obtaining informed consent was not submitted [within five working days after the use occurred].  Specifically, ***
3034 21 CFR 812.150(a)(6) 1 Investigator final report A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation.  Specifically, ***
3035 21 CFR 812.150(a)(7) 1 Investigator report in response to a request Information about a device investigation that was [accurate] [complete] [current] was not provided upon request by [a reviewing IRB] [FDA].  Specifically, ***
3043 21 CFR 812.150(b)(2) 1 Sponsor notification of IRB approval withdrawal Notification of withdrawal of approval of an investigation by a reviewing IRB was not sent [within five working days of withdrawal] to [FDA] [all reviewing IRBs] [all participating investigators].  Specifically, ***
3048 21 CFR 812.150(b)(5) 1 Sponsor progress reports for non-significant risk study For an investigation subject to the abbreviated requirements, progress reports were not [always] submitted to all reviewing IRBs [at required intervals] [at least annually].  Specifically, ***
3049 21 CFR 812.150(b)(5) 1 Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs].  Specifically, ***
3147 21 CFR 820.170(a) 1 Installation instructions, test procedures [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,***
3208 21 CFR 820.50(b) 1 Approval of purchasing data {see also 820.40(a)} The purchasing data were not approved.  Specifically, ***
3229 21 CFR 820.70(h) 1 Documentation of removal or reduction The removal or reduction of manufacturing material has not been documented.  Specifically, ***
3230 21 CFR 820.70(i) 1 Validation of changes to automated process software Changes to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance.   Specifically, ***
3239 21 CFR 820.72(b) 1 Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3267 21 CFR 820.86 1 Maintained The acceptance status of product was not clearly identified throughout [manufacturing] [packaging] [labeling] [installation] [servicing] of the product.  Specifically, ***
3271 21 CFR 820.80(d) 1 Quarantine of finished devices Finished devices were not adequately controlled until acceptance tests were completed, results approved, and devices released.  Specifically, ***
3276 21 CFR 820.80(e) 1 Maintained as part of the DHR {see also 820.184} Acceptance records were not maintained as part of the device history record.  Specifically, ***
3305 21 CFR 820.100(a)(6) 1 Dissemination of problem information - procedure The corrective and preventive action procedures addressing dissemination of information on quality problems and nonconforming product to responsible individuals were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3323 21 CFR 820.170(b) 1 Installer's performance The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation. 
3324 21 CFR 820.170(b) 1 Installer's documentation of results The person installing the device did not document complete inspection and test results to demonstrate proper installation.  Specifically, ***
3355 21 CFR 820.198(f) 1 Records accessible to manufacturing site Investigated complaints and records of investigation were not accessible to the manufacturing establishment.  Specifically, ***
3386 21 CFR 820.25(b)(2) 1 Training on verification/validation defects Employees who perform verification and validation activities have not been made aware of defects and errors they may encounter in performing their jobs.  Specifically, ***
3402 21 CFR 820.80(e)(3) 1 Results Acceptance records did not include the results of certain acceptance activities.  Specifically, ***
3403 21 CFR 820.80(e)(4) 1 Signature Acceptance records did not include the signature of the individual performing the acceptance activities.  Specifically, ***
3412 21 CFR 820.200(d)(4) 1 Servicing individual Service reports do not include the name of service person.  Specifically, ***
3413 21 CFR 820.200(d)(5) 1 Service performed Service reports do not include what service was performed.  Specifically, ***
3420 21 CFR 820.70(a)(5) 1 Criteria for workmanship Criteria for workmanship have not been expressed in documented standards or by means of identified and approved representative samples. Specifically, ***
3664 21 CFR 820.20(b)(2) 1 Training Personnel are not adequately trained to perform [management activities] [work] [assessment activities] [audits]. Specifically, ***
3670 21 CFR 820.20(c) 1 Management review participants Documentation does not show that management with executive responsibility participated in  management reviews. Specifically, ***
3684 21 CFR 820.75(a) 1 Documentation - specific items Documentation of process validation activities and results does not include [the date and signature of the individuals approving the validation] [the major equipment validated].  Specifically, ***
3691 21 CFR 820.100(a)(4) 1 Verification vs validation There is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation.  Specifically, ***
3698 21 CFR 820.150(b) 1 Procedures - receipt and dispatch Procedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, ***
3701 21 CFR 820.250(a) 1 Techniques not used Statistical techniques are not used for control purposes where statistical techniques are applicable.  Specifically, ***
3704 21 CFR 820.250(b) 1 Reviewed for adequacy Sampling methods have not been reviewed for adequacy for their intended use.  Specifically, ***
3705 21 CFR 820.250(b) 1 Review after process change Sampling plans were not reviewed when changes were implemented that might affect statistical sampling methods.  Specifically, ***
3706 21 CFR 820.250(b) 1 Review of sampling methods for adequacy The review of sampling methods for adequacy for their intended use was not documented.  Specifically, ***
3839 21 CFR 820.70(a)(4) 1 Approval of process equipment Process equipment has not been approved.  Specifically, ***
4254 21 CFR 821.30(a) 1 Failure to report A distributor of a tracked device failed to provide required tracking information promptly.  Specifically,***
4436 21 CFR 803.40(a) 1 Report of death, injury by marketed device The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving  information that one of its marketed devices may have caused or contributed to a [death] [serious injury].  Specifically, ***
6805 21 CFR 807.25(b) 1 Device activities not reported Device activities have not been reported to FDA.  Specifically, ***
6847 21 CFR 807.30(b) 1 Listing not updated or update not timely Device listing information was not updated [in a timely manner].  Specifically, ***
6849 21 CFR 812.5(a) 1 Label does not contain required information The label for an investigational device does not include [the name and place of business of manufacturer, packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device.  Limited by Federal (or United States) law to investigational use."].  Specifically, ***
6850 21 CFR 812.5(b) 1 False and misleading label statements The labeling for an investigational device bears a statement that is [false] [misleading].  Specifically, ***
6851 21 CFR 812.5(b) 1 Labeling claims of safety and/or effectiveness The labeling for an investigational device misrepresents that the device is [safe] [effective] for the purposes for which it is being investigated.  Specifically, ***
9111 21 CFR 809.10(a)(4) 1 Hazard warnings/limiting statements An in vitro diagnostic [product label] [outside container] [wrapper]  does not bear [warnings appropriate to the hazard presented by the product] [appropriate limiting statements to the intended use of the product] as required.  Specifically, ***
9112 21 CFR 809.10(a)(5) 1 Reagent storage instructions--protect stability A reagent [product label] [outside container] [wrapper] does not include [adequate] storage instructions [which are based on reliable, meaningful, and specific test methods] [which protect the stability of the product] .  Specifically, *** 
9117 21 CFR 809.10(a)(9)(i) 1 Lot/Control Numbers - multiple unit product Lot or control numbers on a multiple unit in vitro diagnostic [product label] [outside container] [wrapper] do not permit tracing of the identity of the individual units.  Specifically, ***
9147 21 CFR 809.10(b)(11) 1 Expected Values--range(s) The product labeling accompanying an in vitro diagnostic product does not include [a statement of the appropriate range of expected values as obtained with the product from studies of various populations] [a description as to how the range was established] [identification of the population on which the range was established].  Specifically, ***
9673 21 CFR 809.10(c)(2)(i) 1 Not exempt--lacks Research Use Only statement  A [shipment] [delivery] of an in vitro diagnostic product for an investigation which is not subject to part 812  is  not exempt from the requirements for labels and accompanying labeling because all labeling does not bear the prominently placed statement "For Research Use Only. Not for use in diagnostic procedures".  Specifically, ***
14516 21 CFR 812.25(e) 1 Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.  Specifically,***
14518 21 CFR 812.35(a)(3)(iv) 1 No 5 day notification of IDE change FDA was not notified within five working days of [developmental changes that do not constitute a significant change] [manufacturing changes that do not constitute a significant change] [changes to the clinical protocol that do not change the validity of the data or information, scientific soundness of the investigational plan, or the rights, safety, or welfare of the subjects involved].  Specifically, ***
14521 21 CFR 812.36(e) 1 No IRB approval for treatment use A treatment use study of an investigational device did not [comply with the regulations governing informed consent] [have IRB approval].  Specifically, ***
14525 21 CFR 812.2(c)(7) 1 Needs IDE; does not meet definition of a custom device A clinical investigation requires an IDE, as the device does not meet the definition of a custom device in that it is [generally available in finished form for purchase or dispensing upon prescription] [generally available to, or generally used by, other physicians or dentists] [not a modification of a cleared/approved device made to comply with the order of an individual physician or dentist] [offered for commercial distribution through labeling or advertisement].  Specifically, ***

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Drugs

Center Name Cite Id Ref No Frequency Short Description Long Description
Drugs 1105 21 CFR 211.22(d) 165 Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, ***
1358 21 CFR 211.100(b) 115 SOPs not followed / documented Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].  Specifically, ***
2027 21 CFR 211.192 110 Investigations of discrepancies, failures There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.  Specifically, ***
3603 21 CFR 211.160(b) 95 Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity.  Specifically, ***
3585 21 CFR 211.110(a) 94 Control procedures to monitor and validate performance Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.  Specifically, ***
1361 21 CFR 211.100(a) 89 Absence of Written Procedures  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  Specifically, ***
1215 21 CFR 211.67(b) 80 Written procedures not established/followed Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.  Specifically, ***
1112 21 CFR 211.25(a) 79 Training--operations, GMPs, written procedures Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].  Specifically, ***
1213 21 CFR 211.67(a) 67 Cleaning / Sanitizing / Maintenance Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to  prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.  Specifically, ***
1883 21 CFR 211.165(a) 67 Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.  Specifically, ***
1274 21 CFR 211.68(a) 66 Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of  [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  Specifically, ***
2009 21 CFR 211.188 61 Prepared for each batch, include complete information Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch].  Specifically, ***
1177 21 CFR 211.63 60 Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of  drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].  Specifically, ***
2419 21 CFR 211.198(a) 56 Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].  Specifically, ***
9001 21 CFR 211.22(a) 51 Lack of quality control unit There is no quality control unit.  Specifically, ***
1133 21 CFR 211.25(a) 48 GMP Training Frequency GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.  Specifically, ***
4314 21 CFR 211.84(d)(2) 47 Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals].  Specifically, ***
1890 21 CFR 211.165(e) 46 Test methods  The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, ***
4352 21 CFR 211.160(b)(4) 45 Calibration - at intervals, written program, remedial action The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met].  Specifically, ***
1111 21 CFR 211.25(a) 44 Training , Education , Experience overall Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***
1914 21 CFR 211.166(a) 41 Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, ***
4391 21 CFR 211.180(e)(2) 41 Items to cover on annual reviews Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product].  Specifically, ***
2026 21 CFR 211.192 40 Quality control unit review of records Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.  Specifically, ***
4402 21 CFR 211.192 40 Written record of investigation incomplete Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up.  Specifically, ***
1809 21 CFR 211.160(a) 39 Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, ***
1912 21 CFR 211.166(a) 38 Written program not followed The written stability testing program is not followed.  Specifically, ***
1787 21 CFR 211.80(a) 36 Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***
3570 21 CFR 211.100(a) 35 Approval and review of procedures Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].  Specifically, ***
1540 21 CFR 211.125(a) 34 Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, ***
4303 21 CFR 211.67 b) 33 Written procedures fail to include Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation].  Specifically, ***
1767 21 CFR 211.137(a) 32 Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.  Specifically, ***
4413 21 CFR 211.194(a)(8) 32 Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards].  Specifically, ***
4576 21 CFR 211.192 32 No written record of investigation Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications].  Specifically, ***
1227 21 CFR 211.67(c) 31 Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, ***
1451 21 CFR 211.113(b) 30 Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, ***
2028 21 CFR 211.192 30 Extent of discrepancy, failure  investigations Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications]  did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy].  Specifically, ***
2031 21 CFR 211.194(a) 30 Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , ***
4340 21 CFR 211.142 28 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, ***
4389 21 CFR 211.198(a) 28 Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].  Specifically, ***
3565 21 CFR 211.58 26 Buildings not maintained in good state of repair Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.  Specifically, ***
1194 21 CFR 211.42(c) 24 Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
1943 21 CFR 211.180(e)(1) 23 Review of representative number of batches Written procedures are not [established] [followed] for  evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.  Specifically, ***
3572 21 CFR 211.100(b) 23 Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, ***
3632 21 CFR 211.170(b) 23 Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.  Specifically, ***
1975 21 CFR 211.182 22 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, ***
1098 21 CFR 211.22(c) 21 Approve or reject procedures or specs The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.  Specifically, ***
1261 21 CFR 211.68(a) 21 Written calibration / inspection records not  kept Records of the [calibration checks] [inspections] of  automatic, mechanical or electronic equipment, including computers or related systems are not maintained.  Specifically, ***
1452 21 CFR 211.113(b) 21 Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process.  Specifically, ***
2205 21 CFR 211.186(b)(9) 21 Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions].  Specifically, ***
3571 21 CFR 211.100(a) 21 Changes to Procedures Not Reviewed, Approved Changes to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***
1810 21 CFR 211.160(a) 20 Lab controls established, including changes The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***
4372 21 CFR 211.188(b)(8) 20 Labeling control records including specimens or copies Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.  Specifically, ***
1550 21 CFR 211.125(f) 19 Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
1942 21 CFR 211.180(e) 19 Records reviewed annually  Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.  Specifically, ***
2007 21 CFR 211.186(a) 19 Signature and checking of records -- 2 persons The master production and control records for each batch size of drug product are not  [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person].  Specifically, ***
3547 21 CFR 211.46(b) 18 Equipment for Environmental Control Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.  Specifically, ***
4306 21 CFR 211.80(a) 18 Written Procedures Not Followed Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***
1450 21 CFR 211.113(a) 17 Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].  Specifically, ***
3583 21 CFR 211.110(a) 17 Written in-process control procedures Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch.  Specifically, ***
3602 21 CFR 211.160(a) 17 Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, ***
4336 21 CFR 211.150 17 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, ***
4342 21 CFR 211.142(b) 17 Storage under appropriate conditions Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.  Specifically, ***
1626 21 CFR 211.130 16 Procedures are written, and followed Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].  Specifically, ***
1833 21 CFR 211.84(d)(1) 16 Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.  Specifically, ***
1891 21 CFR 211.165(f) 16 Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, ***
2619 21 CFR 211.198(b)(2) 16 Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, ***
1411 21 CFR 211.105(b) 15 Distinctive ID or code not recorded in batch record The batch records do not record the distinctive [identification number] [code] [name of equipment]  to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.  Specifically, ***
1434 21 CFR 211.42(c)(10)(iv) 15 Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***
1790 21 CFR 211.80(b) 15 Handling and Storage to Prevent Contamination There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.  Specifically, ***
1801 21 CFR 211.84(a) 15 Components withheld from use pending release Each lot of [components] [drug product containers] [closures] is not withheld  from use until the lot has been sampled, tested, examined, and released by the quality control unit.  Specifically, ***
2034 21 CFR 211.194(d) 15 Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, ***
4307 21 CFR 211.80(d) 15 Status of Each Lot Identified Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected.  Specifically, ***
4369 21 CFR 211.188(b)(11) 15 Identification of persons involved, each significant step Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced.  Specifically, ***
1885 21 CFR 211.165(b) 14 Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, ***
3561 21 CFR 211.56(b) 14 Written sanitation procedures lacking There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation.  Specifically, ***   
6732 21 CFR 314.80(c)(1)(i) 14 Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.  Specifically, ***
1448 21 CFR 211.111 13 Establishment of time limitations Time limits are not established when appropriate  for the completion of each production phase to assure the quality of the drug product.  Specifically, ***
1926 21 CFR 211.166(b) 13 Adequate number of batches on stability An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date.  Specifically, ***
3613 21 CFR 211.160(b)(4) 13 Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].  Specifically, ***
4401 21 CFR 211.186(b)(9) 13 Complete instructions, procedures, specifications et. al. Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].  Specifically, ***
1134 21 CFR 211.25(b) 12 Supervisor Training/Education/Experience Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the  [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.  Specifically, ***
1263 21 CFR 211.68(b) 12 Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.  Specifically, ***
1844 21 CFR 211.84(d)(2) 12 Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1978 21 CFR 211.182 12 Personnel  dating/signing equipment log The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, ***
2033 21 CFR 211.194(c) 12 Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].  Specifically, ***
3559 21 CFR 211.56(a) 12 Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***
3616 21 CFR 211.165(d) 12 Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release.  Specifically, ***
4338 21 CFR 211.150(b) 12 Recall facilitation A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.  Specifically, ***
8911 21 CFR 314.81(b)(1)(ii) 12 Failure to meet specifications An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.   Specifically, ***
1270 21 CFR 211.68(b) 11 input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, *** 
1886 21 CFR 211.165(c) 11 Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested].  Specifically, ***
4368 21 CFR 211.188(b)(12) 11 Investigations made into any unexplained discrepancy Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.  Specifically, ***
8907 21 CFR 314.81(b)(1)(ii) 11 Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product.   Specifically, ***
1033 21 CFR 211.22(a) 10 Authority lacking to review records, investigate errors The quality control unit lacks authority  to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].  Specifically, ***
1169 21 CFR 211.42(a) 10 Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.  Specifically, ***
1920 21 CFR 211.166a)(3) 10 Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, ***
4315 21 CFR 211.84(d)(2) 10 Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically, ***
4353 21 CFR 211.160(b)(4) 10 Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, ***
4357 21 CFR 211.166(a) 10 Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, ***
1049 21 CFR 211.22(a) 9 Approve or reject components, products  The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].  Specifically, ***
1136 21 CFR 211.25(c) 9 Inadequate number of  personnel The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
1395 21 CFR 211.103 9 Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product.  Specifically, ***
1454 21 CFR 211.115(a) 9 Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are  not [written] [followed].  Specifically, ***
1505 21 CFR 211.122(d) 9 Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, ***
1632 21 CFR 211.130(c) 9 Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.  Specifically, ***
1802 21 CFR 211.84(b) 9 Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, ***
2008 21 CFR 211.186(a) 9 Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, *** 
2567 21 CFR 211.198(a) 9 Adverse Drug Experience Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent [serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***
3582 21 CFR 211.105(a) 9 Identification of containers, lines, equipment All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch].  Specifically, *** 
4341 21 CFR 211.142(a) 9 Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.  Specifically, ***
4373 21 CFR 211.188(b)(7) 9 Actual yield, % of theoretical yield The batch production and control records do not include a statement of the [actual yield] [percentage of theoretical yield] at appropriate stages of processing for each batch of drug product produced.  Specifically, ***
4400 21 CFR 211.186(b)(8) 9 Description of containers, labels, et. al. Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling].  Specifically, ***
3557 21 CFR 211.52 8 Washing and toilet facilities are deficient Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, ***
3614 21 CFR 211.160(b)(4) 8 Written calibration procedures Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met].  Specifically, ***
4377 21 CFR 211.188(b(3) 8 Identification of each  component or in-process material Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced.  Specifically, ***
4406 21 CFR 211.194(a)(2) 8 Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.  Specifically, ***
1086 21 CFR 211.22(b) 7 Adequate lab facilities not available  Adequate lab facilities for testing and approval or rejection of [components] [drug product containers] [closures] [packaging materials] [in-process materials] [drug products] are not available to the quality control unit.  Specifically, ***
1495 21 CFR 211.122(a) 7 Written procedures describing in detail There is a lack of written  procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials.  Specifically, ***
1777 21 CFR 211.150(b) 7 Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.  Specifically,  ***
4366 21 CFR 211.188(a) 7 Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was  checked for accuracy, dated and signed.  Specifically, ***
1456 21 CFR 211.115(b) 6 Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, ***
1774 21 CFR 211.142(a) 6 Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.  Specifically, ***
1798 21 CFR 211.82(b) 6 Quarantine Storage of Components Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, ***
2003 21 CFR 211.184(c) 6 Individual inventory record Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated  batch or lot of drug product.  Specifically, ***
2035 21 CFR 211.194(e) 6 Stability testing records not  included Laboratory records do not include complete records of all stability testing performed.  Specifically, ***
3550 21 CFR 211.46(c) 6 Exhaust systems inadequate to control air contamination Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.  Specifically, ***
3562 21 CFR 211.56(c) 6 Written procedures lacking for use of pesticides etc. Written procedures are lacking for the use of  [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products].  Specifically, ***
3629 21 CFR 211.170(b) 6 Reserve samples identified, representative, stored Reserve drug product samples  are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling].  Specifically, ***
4404 21 CFR 211.194(a)(1) 6 Sample identification and other information Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing].  Specifically, *** 
1079 21 CFR 211.22(a) 5 Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.  Specifically, ***
1162 21 CFR 211.28(a) 5 Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, ***
1449 21 CFR 211.111 5 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, ***
1498 21 CFR 211.122(b) 5 Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use].  Specifically, *** 
1728 21 CFR 211.87 5 Retest of approved components/containers/closures Approved [components] [drug product containers] [closures] are not retested or reexamined as appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to conditions that might have an adverse effect]  with subsequent approval or rejection by the quality control unit.  Specifically, *** 
1797 21 CFR 211.82(a) 5 Examination on receipt, before acceptance Each container or grouping of containers of [components] [drug product containers] [closures] is not examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container damage] [broken seals]  [contamination]. Specifically, ***
1851 21 CFR 211.84(e) 5 Rejecting  When Specifications Not Met Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity.  Specifically, ***
1879 21 CFR 211.180(c) 5 Records not made readily available to FDA Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection.  Specifically, ***
1917 21 CFR 211.166(a)(1) 5 Sample size - test intervals The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability.  Specifically, ***
3553 21 CFR 211.48(a) 5 Plumbing System Defects The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, ***
4320 21 CFR 211.84(d)(6) 5 Microbiological Contamination Exam Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.  Specifically, ***
4323 21 CFR 211.115(a) 5 Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.  Specifically, ***
4351 21 CFR 211.160(b)(3) 5 Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, ***
4378 21 CFR 211.188(b)(2) 5 Identity of major equipment and lines used Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.  Specifically, ***
4409 21 CFR 211.194(a)(4) 5 Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested].  Specifically, ***
4410 21 CFR 211.194(a)(5) 5 Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, *** 
6730 21 CFR 314.80(b) 5 Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, ***
1159 21 CFR 211.28(a) 4 Clothing appropriate for duties performed Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not  appropriate for the duties they perform.  Specifically, ***
1266 21 CFR 211.42(d) 4 Penicillin processing area not  kept separate The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use.  Specifically,  ***
1388 21 CFR 211.101(d) 4 Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.  Specifically, ***
1435 21 CFR 211.42(c)(10)(v) 4 Cleaning System Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***
1636 21 CFR 211.130(e) 4 Packaging line inspection before use Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations.  Specifically, ***
1637 21 CFR 211.130(e) 4 Packaging line inspection after use Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.  Specifically, ***
1869 21 CFR 211.94(c) 4 Containers & Closures Clean, Sterilized, Pyrogen-free Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use.  Specifically, ***
1976 21 CFR 211.182 4 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, ***
2012 21 CFR 211.188(b) 4 Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding].  Specifically, ***
2020 21 CFR 211.188(b)(8) 4 Labeling Control Records and Label Copies The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, ***
2203 21 CFR 211.186(b)(7) 4 Theoretical Yield and Percentages The master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum] [maximum] [yield percentages].  Specifically, ***
3591 21 CFR 211.110(b) 4 In-process materials specifications In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures where appropriate].  Specifically, ***
3592 21 CFR 211.110(c) 4 In-process materials characteristics testing In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, ***
3639 21 CFR 211.204 4 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, ***
4304 21 CFR 211.68(b) 4 Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.  Specifically, ***
4309 21 CFR 211.84(c)(2) 4 Containers sampled so as to prevent contamination Containers are not [opened] [sampled] [resealed] in a manner designed to prevent contamination of [their contents] [other components] [other drug product containers or closures].  Specifically, ***
4313 21 CFR 211.84(c)(6) 4 Containers Marked to Show Samples Taken Containers from which samples have been taken are not marked to show that samples have been taken from them.  Specifically, ***
4325 21 CFR 211.110(a) 4 Control procedures fail to include the following Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions].  Specifically,***
4328 21 CFR 211.122(a) 4 Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, ***
4355 21 CFR 211.165(c) 4 Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***  
4370 21 CFR 211.188(b)(10) 4 Records of any sampling performed Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.  Specifically, ***
4399 21 CFR 211.186(b)(7) 4 Theoretical yield statement including percentages Master production and control records lack a statement of theoretical yield [including the maximum and minimum percentages of theoretical yield beyond which investigation is required].  Specifically, ***
4412 21 CFR 211.194(a)(7) 4 Signatures and dates--person who performs test Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].  Specifically, ***
1163 21 CFR 211.28(b) 3 Habits of good sanitation & health  Production personnel were not practicing good sanitation and health habits.  Specifically, ***
1168 21 CFR 211.34 3 Consultant Records Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided].  Specifically, ***
1220 21 CFR 211.67(b)(3) 3 Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.  Specifically, ***
1222 21 CFR 211.67(b)(4) 3 Cleaning SOPs/equipment identification Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.  Specifically, ***
1256 21 CFR 211.68(b) 3 Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.  Specifically, ***
1436 21 CFR 211.42(c)(10)(vi) 3 Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, ***
1496 21 CFR 211.122(a) 3 Sampling/testing of labeling/packaging materials Labeling and packaging materials are not  [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.  Specifically, ***
1629 21 CFR 211.130(a) 3 Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, *** 
1630 21 CFR 211.130(b) 3 Unlabeled filled containers controls Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of individual containers, lots or portions of lots.  Specifically, ***
1633 21 CFR 211.130(d) 3 Examination of packaging and labeling Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].  Specifically, ***
1725 21 CFR 211.134(c) 3 Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, ***
1770 21 CFR 211.137(d) 3 Expiration date location on labeling Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations..  Specifically, ***
1843 21 CFR 211.84(d)(2) 3 Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically,  ***
1876 21 CFR 211.180(a), (b) 3 Record maintenance 1 year (except exempt OTC) All records of  [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date.  Specifically, ***
1918 21 CFR 211.166(a)(2) 3 Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, ***
1957 21 CFR 211.180(e)(2) 3 Review of problem drugs The procedures for the annual quality standards record evaluation are deficient in that they do not  address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product.  Specifically, ***
1977 21 CFR 211.182 3 Dedicated equipment: records part of batch record The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.  Specifically, ***
2017 21 CFR 211.188(b)(5) 3 In-Process and Laboratory Control Results The batch production and control records are deficient in that they do not  include [in-process] [laboratory] control results.  Specifically, ***
2021 21 CFR 211.188(b)(9) 3 Container/Closure Description The batch production and control records are deficient in that they do not include a description of drug product containers and closures.  Specifically, ***
2200 21 CFR 211.186(b)(4) 3 Variation in the Amount of Components Used The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form.  Specifically, ***
2402 21 CFR 211.194(a)(5) 3 Testing Calculations Laboratory records are deficient in that they do not include all calculations performed during testing.  Specifically, ***
2618 21 CFR 211.198(b)(1) 3 Complaint Record required information Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***
2621 21 CFR 211.198(b)(3) 3 Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, ***
3594 21 CFR 211.110(d) 3 Rejected in-process materials not quarantined Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***
3611 21 CFR 211.160(b)(3) 3 Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, ***
3615 21 CFR 211.160(b)(4) 3 Test devices not meeting specifications Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.  Specifically, ***
3623 21 CFR 211.170(a) 3 Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].   Specifically, ***
3641 21 CFR 211.204 3 Record information inclusions Records of returned drug products do not include the  [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity] [date of disposition] [ultimate disposition].  Specifically, ***
4302 21 CFR 211.56(b) 3 Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, ***
4305 21 CFR 211.68(b) 3 Backup data not assured as exact and complete Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, ***
4316 21 CFR 211.84(d)(3) 3 Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, ***
4317 21 CFR 211.84(d)(3) 3 Certificates of Testing (Containers, Closures) Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals].  Specifically, ***
4322 21 CFR 211.101(d) 3 Component release checked by 2nd person Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properly identified].  Specifically, ***
4349 21 CFR 211.160(b)(2) 3 In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, ***
4375 21 CFR 211.188(b)(5) 3 In-process and laboratory control results  Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.  Specifically, ***
4376 21 CFR 211.188(b)(4) 3 Weights and measures of components used Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.  Specifically, ***
4380 21 CFR 211.198(b)(3) 3 Determination not to conduct investigation of complaint The written record did not include the [reason an investigation was found not to be necessary] [name of the responsible person making the determination not to conduct an investigation] when an investigation into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] was not conducted.  Specifically, *** 
4382 21 CFR 211.198(b)(2) 3 Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].  Specifically, ***
4388 21 CFR 211.198(a) 3 Complaints reviewed by Quality Control Unit Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need for an investigation of any unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications].  Specifically, ***
4396 21 CFR 211.186(b)(4) 3 Variations in component amounts  not justified The master production and control records indicate unjustified variations in the amount of components necessary for preparation of the dosage form.  Specifically, ***
4403 21 CFR 211.194(b) 3 Test method modification records do not  include Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method].  Specifically, ***
4407 21 CFR 211.194(a)(2) 3 Reference and method not stated Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].  Specifically, ***
6736 21 CFR 314.80(c)(1)(ii) 3 Submission of report follow-up Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as requested by FDA] concerning post marketing 15-day reports.  Specifically, ***
6833 21 CFR 314.80(c)(2)(ii) 3 Incomplete periodic safety report Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences].  Specifically, ***
8935 FDCA 760(b)(1) 3 Failure of responsible person to report AE (non-RX Drug)   Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, ***
1207 21 CFR 211.65(b) 2 Substances That Come in Contact Substances required for equipment operations such as lubricants and coolants come in contact with [components] [drug product containers] [closures] [in-process materials] [drug product] so as to alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.  Specifically, ***
1224 21 CFR 211.67(b)(6) 2 Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  Specifically, ***
1393 21 CFR 211.103 2 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person.  Specifically, ***
1396 21 CFR 211.42(c)(2) 2 Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.  Specifically,***
1413 21 CFR 211.42(c)(5) 2 Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  Specifically, ***
1421 21 CFR 211.42(c)(10) 2 Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.  Specifically,***
1430 21 CFR 211.42(c)(10)(i) 2 Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***
1433 21 CFR 211.42(c)(10)(iii) 2 Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, ***
1541 21 CFR 211.125(b) 2 Examination of issued labels Labeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records.  Specifically, ***
1546 21 CFR 211.125(d) 2 Destruction of excess labels with lot numbers Excess labeling bearing lot or control numbers is not destroyed.  Specifically, ***
1722 21 CFR 211.134(a) 2 Correct labels during finishing operations Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.  Specifically, ***
1794 21 CFR 211.80(d) 2 Disposition recorded by lot identification The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.  Specifically, ***
1842 21 CFR 211.84(d)(1) 2 Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.  Specifically,***
1852 21 CFR 211.94(a) 2 Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.  Specifically, ***
1922 21 CFR 211.166(a)(4) 2 Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.  Specifically, *** 
1927 21 CFR 211.166(b) 2 Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not  supported with ongoing full shelf life studies.  Specifically, ***
1932 21 CFR 211.167(a) 2 Sterility/pyrogen-free testing  Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.  Specifically, ***
2004 21 CFR 211.184(d) 2 Labeling: documentation of exam and review There is no documentation of the examination and review of labels and labeling for conformity with [established specifications] [the assigning of a lot or control number].  Specifically, ***
2019 21 CFR 211.188(b)(7) 2 Documentation of Actual Yield and Theoretical Yield The batch production and control records are deficient in that they do not  include a statement of the [actual yield] [percentage of theoretical yield].  Specifically, ***
2399 21 CFR 211.194(a)(2) 2 Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records].  Specifically, ***
2401 21 CFR 211.194(a)(4) 2 Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, ***
2406 21 CFR 211.194(a)(8) 2 Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, ***
3445 21 CFR 211.65(a) 2 Equipment construction - reactive surfaces Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.  Specifically, ***
3545 21 CFR 211.44 2 Adequate lighting not provided Adequate lighting is not provided in all  areas.  Specifically, ***
3548 21 CFR 211.46(c) 2 Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.  Specifically, ***
3551 21 CFR 211.46(d) 2 Penicillin air handling systems not kept separate Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate  from those for other drug products for human use.  Specifically, ***
3567 21 CFR 211.84(d)(2) 2 Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, ***
3569 21 CFR 211.89 2 Quarantine of Rejected Components et. al. Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***
3631 21 CFR 211.170(b) 2 Investigation of reserve sample deterioration Evidence of reserve drug product sample deterioration was not  [investigated] [recorded and maintained with other stability data].  Specifically, ***
4324 21 CFR 211.110(b) 2 In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, ***
4343 21 CFR 211.160(b)(1) 2 Incoming lots - conformance to written specs- Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of drug products.  Specifically, ***
4344 21 CFR 211.160(b)(1) 2 Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, ***
4345 21 CFR 211.160(b)(1) 2 Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified].  Specifically, ***
4348 21 CFR 211.160(b)(2) 2 In-process materials - sampling, testing procedures Laboratory controls do not include a description of [sampling] [testing] procedures for in-process materials.  Specifically, ***
4350 21 CFR 211.160(b)(3) 2 Drug products-sampling procedures/specifications Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.  Specifically, ***
4359 21 CFR 211.170(a)(1), (b)(1) 2 Retention time of reserve samples, in general Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product.
4360 21 CFR 211.170(b) 2 Reserve drug product sample quantity - all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.  Specifically, ***
4364 21 CFR 211.176 2 Failing to test for penicillin cross-contamination Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.  Specifically, ***
4383 21 CFR 211.198(b)(1) 2 Written complaint record must include Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***
4385 21 CFR 211.198(b) 2 Records maintained for 1 year (except certain  OTC drugs) Written complaint file records involving a drug product are not maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date the complaint was received, whichever is longer.  Specifically, ***
4387 21 CFR 211.198(a) 2 Reporting of adverse drug experience to FDA Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.  Specifically, ***
4405 21 CFR 211.194(a)(2) 2 Statement of methods and data Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested].  Specifically, *** 
4411 21 CFR 211.194(a)(6) 2 Test results, comparison with standards not included Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested.  Specifically, ***
4415 21 CFR 211.204 2 Returned drug products with doubt cast as to safety et. al. Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters].  Specifically, ***
6728 21 CFR 314.80(b) 2 Failure to review ADE information Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers].  Specifically, ***
6830 21 CFR 314.80(c)(2) 2 Interval Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an application which was approved less than three years ago] [yearly for an application which was approved three or more years ago].  Specifically, ***
6831 21 CFR 314.80(c)(2) 2 Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.  Specifically, ***
6832 21 CFR 314.80(c)(2) 2 Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.  Specifically, ***
8908 21 CFR 314.81(b)(2)(i) 2 Summary An annual report did not include [a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief description of actions the applicant has taken or intends to take as a result of this new information] [a brief description of actions the applicant has taken or intends to take as a result of new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product] [a brief statement whether labeling supplements for pediatric use have been submitted and whether new studies in the pediatric population have been initiated].  Specifically, ***
8912 21 CFR 314.81(b)(2) 2 Timely submission An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application.   Specifically, ***
1167 21 CFR 211.34 1 Qualifications lacking Consultants lack sufficient education, training and experience to advise on the subject for which they are retained.  Specifically, ***
1174 21 CFR 211.42(b) 1 Product flow through building is inadequate The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, ***
1223 21 CFR 211.67(b)(5) 1 Cleaning SOPs/equipment protection Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.  Specifically, ***
1251 21 CFR 211.42(c)(1) 1 Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.  Specifically, ***
1371 21 CFR 211.101(a) 1 Batches Formulated to less than 100% Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, ***
1409 21 CFR 211.42(c)(4) 1 In-Process Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.  Specifically, ***
1418 21 CFR 211.42(c)(7) 1 Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.  Specifically, ***
1431 21 CFR 211.42(c)(10)(ii) 1 Temperature / Humidity Controls Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, ***
1503 21 CFR 211.122(c) 1 Records not kept for each shipment Records are not maintained for each shipment received of each different labeling and packaging material.  Specifically, ***
1506 21 CFR 211.122(e) 1 Destruction of obsolete labeling Obsolete or outdated labels, labeling and packaging materials are not destroyed.  Specifically, ***
1509 21 CFR 211.122(h) 1 Printing devices Printing devices used to imprint labeling upon the drug product [unit label] [case] are  not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
1545 21 CFR 211.125(c) 1 Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated].  Specifically, ***
1724 21 CFR 211.134(b) 1 Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, ***
1726 21 CFR 211.86 1 Rotation of components/containers/closures There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first.  Specifically, *** 
1791 21 CFR 211.80(c) 1 Storage off Floor, Spaced Suitably Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection].  Specifically, ***
1824 21 CFR 211.84(c)(5) 1 Identifying Sample Containers Sample container identification of sampled item is deficient in that it does not include the [name of the material sampled] [lot number] [container from which the sample was taken] [date on which the sample was taken] [name of the person who collected the sample].   Specifically, ***
1825 21 CFR 211.84(c)(6) 1 Identifying Containers Sampled Markings of containers from which samples have been taken are deficient in that they do not show that samples have been removed from them. Specifically,  ***
 
1846 21 CFR 211.84(d)(3) 1 Establish reliability of supplier's C of A Establishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1849 21 CFR 211.84(d)(6) 1 Objectionable microbiological contamination Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  Specifically,  ***
1939 21 CFR 211.167(c) 1 Controlled release test methods written, followed Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed].  Specifically, ***
1958 21 CFR 211.180(f) 1 Responsible firm officials notified in writing Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions,  are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices].  Specifically, ***
1979 21 CFR 211.182 1 Chronological Order of Equipment Log Entries The entries in the equipment cleaning and use logs are not in chronological order.  Specifically, ***
2001 21 CFR 211.184(b) 1 Component Test Records The [component] [drug product container] [closure] [labeling] records do not include the [results of tests or examinations performed] [the conclusions derived from tests or examinations performed].  Specifically, ***
2005 21 CFR 211.184(e) 1 Records of disposition of rejected material Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling].  Specifically, ***
2011 21 CFR 211.188(a) 1 Accurate reproduction The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed].  Specifically, ***
2014 21 CFR 211.188(b)(2) 1 Identification of Equipment and Lines The batch production and control records are deficient in that they do not  include the identity of major [equipment] [lines] used.  Specifically, ***
2015 21 CFR 211.188(b)(3) 1 Identification of Components and In-Process Materials The batch production and control records are deficient in that they do not include specific identification of each [batch of component] [in-process material] used.  Specifically, ***
2016 21 CFR 211.188(b)(4) 1 Weights and Measures of Components Used The batch production and control records are deficient in that they do not  include [weights] [measures] of components used in the process.  Specifically, ***
2022 21 CFR 211.188(b)(10) 1 Documentation of Sampling Performed The batch production and control records are deficient in that they do not include documentation of sampling performed.  Specifically, ***
2023 21 CFR 211.188(b)(11) 1 Identification of Persons Performing Significant Steps The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation.  Specifically, ***
2024 21 CFR 211.188(b)(12) 1 Documentation of Batch Investigations The batch production and control records are deficient in that they do not  include documentation of batch investigations performed.  Specifically, ***
2032 21 CFR 211.194(b) 1 Test method modification records not maintained Complete records are not maintained of any modification of an established method employed in testing.  Specifically, ***
2089 21 CFR 211.208 1 No records maintained No records are maintained for salvaged drug products.  Specifically, ***
2397 21 CFR 211.194(a)(1) 1 Description and Identification of Samples Laboratory records are deficient in that they do not include a [description and identification of the sample received] [quantity] [lot number] [date sample taken] [date sample received for testing].  Specifically, ***
2420 21 CFR 211.198(a) 1 Quality Control Review Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.  Specifically, ***
2569 21 CFR 211.198(b) 1 Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.  Specifically, ***
3554 21 CFR 211.48(a) 1 Potable water standards not met The potable water being permitted for use in the potable water system fails to meet  standards prescribed by the Environmental Protection Agency.  Specifically, ***
3555 21 CFR 211.48(b) 1 Drains--Size, Back-siphonage Prevention Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer].  Specifically, ***
3556 21 CFR 211.50 1 Sewage and refuse disposal in safe manner Disposal of  [sewage] [trash] [refuse] from the [building] [immediate premises] is not done  in a safe and sanitary manner.  Specifically, ***
3558 21 CFR 211.52 1 Washing and toilet facilities not provided and accessible Washing and toilet facilities are not [provided] [easily accessible to working areas].  Specifically, ***
3573 21 CFR 211.101(b) 1 Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, ***
3581 21 CFR 211.101(d) 1 Verification of component addition Each component is not added to the batch by one person and verified by a second person..  Specifically, ***
3588 21 CFR 211.110(a)(3) 1 Mixing adequacy The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.  Specifically, ***
3605 21 CFR 211.160(b)(1) 1 Specification description of sample/testing The specifications for components, drug product containers or closures and labeling are deficient in that they do not include a description of the [sampling plan] [testing procedures].  Specifically, ***
3606 21 CFR 211.160(b)(1) 1 Retesting The specifications for [components] [drug product containers] [closure] are deficient in that they do not include appropriate retesting requirements.  Specifically, ***
3609 21 CFR 211.160(b)(2) 1 In-process sample representation/identification In-process samples are not [representative] [properly identified]. Specifically, ***
3610 21 CFR 211.160(b)(3) 1 Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, ***
3630 21 CFR 211.170(b) 1 Drug product reserve containers Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product].  Specifically, ***
3633 21 CFR 211.170(b)(1) 1 Reserve sample retention time The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3)) is deficient in that they are not retained for one year after the expiration date of the drug product.  Specifically, ***
3640 21 CFR 211.204 1 Returned drug products identified and held Returned drug products are not [identified as such] [held].  Specifically, ***
4308 21 CFR 211.94(d) 1 Written Procedures to Remove Pyrogens Not Followed Written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilizing] [methods of processing] to remove pyrogenic properties of drug product containers and closures are not followed.  Specifically, ***
4312 21 CFR 211.84(c)(5) 1 Sample Containers Identification Sample containers were not identified in a manner which allows determination of  [name of the material sampled] [lot number] [container from which the sample was taken] [name of person who collected the sample].  Specifically, ***.
4318 21 CFR 211.84(d)(4) 1 Microscopic Exam of Components Components are not microscopically examined when appropriate.  Specifically, ***
4319 21 CFR 211.84(d)(5) 1 Exam for Filth, Insects, Extraneous Adulterants Each lot of  [components] [drug product containers] [closures] that is liable to contamination with filth, insect infestation or other extraneous adulterants is not examined against established specifications for such contamination.  Specifically, ***
4321 21 CFR 211.101(b) 1 Identification of new containers For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number].  Specifically, ***
4327 21 CFR 211.122(c) 1 Records fail to include Records kept for each different labeling and packaging material shipment fail to include [the receipt] [results of examination or testing] [a statement of whether the shipment was accepted or rejected].  Specifically, ***
4330 21 CFR 211.130(e) 1 Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, ***
4354 21 CFR 211.165(d) 1 Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, ***
4356 21 CFR 211.166(b) 1 Tentative expiration date  Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the appropriate expiration date determined.  Specifically, ***
4362 21 CFR 211.170(a)(3), (b)(3) 1 Retention time for exempt OTC drug products Reserve samples for [active ingredients in OTC drug products] [OTC drug products] which are exempt from bearing an expiration date are not retained for 3 years after the lot or batch of drug product is distributed.  Specifically, *** 
4374 21 CFR 211.188(b)(6) 1 Inspection of packaging and labeling area Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced.  Specifically, ***
4386 21 CFR 211.198(b) 1 Written complaint record  to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or packed provided the written records are readily available for inspection at that other facility].  Specifically, *** 
4392 21 CFR 211.186(b)(1) 1 Name, strength, dosage form  The master production and control records do not include [the name and strength of the product] [a description of the dosage form].  Specifically, ***
4394 21 CFR 211.186(b)(3) 1 Components complete listing The master production and control records do not include a complete list of components [designated by names or codes sufficiently specific to indicate any special quality characteristics].  Specifically, ***
4395 21 CFR 211.186(b)(4) 1 Weight or measure of each component The master production and control records lack an accurate statement of the [weight]  [measure] of each component [using the same weight system for each component]. Specifically, ***
4408 21 CFR 211.194(a)(3) 1 Weight or measure of sample Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate.  Specifically, ***
4416 21 CFR 211.204 1 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, ***
4417 21 CFR 211.204 1 Associated batches implicated, investigated No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products.   Specifically, ***
6704 21 CFR 310.305(c) 1 Submission of report to incorrect office Postmarketing 15-day Alert reports have been submitted to FDA, but not to FDA's Division of Pharmacovigilance and Epidemiology.  Specifically, ***
 
6823 21 CFR 314.80(c) 1 Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA.  Specifically, ***
6825 21 CFR 314.80(c)(1)(iii) 1 Non-applicant reports to applicant You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected.  However, you did not submit each report to the applicant [within five calendar days of your receipt of the information].  Specifically, ***
6829 21 CFR 314.80(c)(2) 1 Failure to report non-alert ADEs Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.  Specifically, ***
6840 21 CFR 314.80(f)(1) 1 Wrong form - domestic ADE An FDA Form 3500A has not been completed for each report of a domestic adverse drug experience.  Specifically, ***
6841 21 CFR 314.80(f)(1) 1 Wrong form - foreign ADE An FDA Form 3500A or CIOMS I form has not been completed for each report of a foreign adverse drug experience.  Specifically, ***
8906 21 CFR 314.81(b)(1)(i) 1 Mix-up An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another article.   Specifically, ***
8910 21 CFR 314.81(b)(2)(iii) 1 Labeling information An annual report did not include [currently used professional labeling] [patient brochures or package inserts] [a representative sample of the package labels] [a summary of any changes in labeling that have been made since the last report, listed by date in the order in which they were implemented, or if no changes, a statement of that fact].   Specifically, ***
8913 21 CFR 314.81(b)(2)(iv)(a) 1 Reports re: chemical, physical, or other properties An annual report did not include reports of [experiences] [investigations] [studies] [tests] involving [chemical or physical properties] [properties of the drug] which, as new information, might affect FDA's previous conclusions about the safety or effectiveness of the drug.   Specifically, ***
8917 21 CFR 314.81(b)(2)(vi)(b) 1 Completed, unpublished clinical trials An annual report did not include [summaries] [prepublication manuscripts] of completed, unpublished clinical trials conducted by, or otherwise obtained by, the applicant.   Specifically, ***
8922 21 CFR 314.81(b)(2)(viii) 1 Post marketing study status report for other studies An annual report did not include a status report for all post marketing studies being performed by, or on behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii).  Specifically, ***
10022 21 CFR 310.305(a) 1 Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of postmarketing adverse drug experiences. Specifically, ***

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Bioresearch monitoring

Center Name Cite Id Ref No Frequency Short Description Long Description
Bioresearch monitoring 7560 21 CFR 312.60 153 FD-1572, protocol compliance An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically***
7530 21 CFR 312.62(b) 87 Case history records- inadequate or inadequate Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent].   Specifically, ***
7526 21 CFR 312.62(a) 46 Accountability records Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].  Specifically, ***
7281 21 CFR 56.108(a)(1) 45 Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
7318 21 CFR 56.115(a)(2) 40 Minutes of IRB meetings Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution].  Specifically, ***
7227 21 CFR 50.27(a) 32 Consent form not approved/signed/dated Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject’s legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***
7334 21 CFR 56.115(a)(5) 22 List of members A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity]  [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution].  Specifically, ***
7498 21 CFR 312.66 22 Unanticipated problems Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, ***
7562 21 CFR 312.60 21 Informed consent Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests] .  Specifically***
7482 21 CFR 312.50 19 General responsibilities of sponsors Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the  protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks].  Specifically, ***
7290 21 CFR 56.108(c) 17 Members present for review For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.  Specifically, ***
7321 21 CFR 56.110(c) 17 Method to keep members advised The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure.  Specifically, *** 
7552 21 CFR 312.66 16 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation.  Specifically, ***
7335 21 CFR 56.115(a)(6) 14 Written procedures per 56.108(a) and (b) Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).  Specifically, ***
7391 21 CFR 50.25(a)(5) 12 Confidentiality, FDA inspection of records There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records].  Specifically, ***
7520 21 CFR 312.64(b) 12 Safety reports Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***
7231 21 CFR 50.20 11 Consent not obtained, exceptions do not apply Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.  Specifically, ***
7278 21 CFR 56.107(e) 11 Conflict of interest The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest.  Specifically, ***
7342 21 CFR 56.108(b)(2) 11 Prompt reporting of noncompliance The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA]  of any instance of serious or continuing noncompliance with theses regulations or the requirements or determinations of the IRB.  Specifically, ***
7286 21 CFR 56.108(b)(1) 10 Prompt reporting of unanticipated problems The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others.  Specifically, ***
7654 21 CFR 56.110(b) 10 Research not eligible for expedited review The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year].   Specifically, ***  
7293 21 CFR 56.109(f) 9 Continuing review The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year].  Specifically, ***
7343 21 CFR 56.108(b)(3) 9 Reporting  of suspension/termination The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .  Specifically, ***
7392 21 CFR 50.25(a)(7) 9 Whom to contact The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and research subjects' rights] [in the event of a research-related injury to the subject].  Specifically, ***
7411 21 CFR 312.53(c)(1) 9 Investigator statement (FDA 1572) Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.  Specifically, ***
7480 21 CFR 312.50 8 Ensuring compliance with plan and protocol Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.  Specifically, ***
7517 21 CFR 312.66 7 Initial and continuing review Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study.  Specifically, ***
3923 21 CFR 58.33(f) 6 Study director: transfer of data to archives The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study.  Specifically, ***
4007 21 CFR 58.130(a) 6 Conduct: in accordance with protocol Not all nonclinical laboratory studies were conducted in
accordance with the protocol.  Specifically, ***
7368 21 CFR 56.108(a)2) 6 More frequent reviews, verification of no changes The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, ***
7371 21 CFR 56.108(a)(1) 6 Reporting findings and actions to investigator/institution The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution].  Specifically, ***
7209 21 CFR 50.25(a)(1) 5 Procedures, identification of those which were experimental The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental].  Specifically, ***
7277 21 CFR 56.107(d) 5 One non-affiliate member The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution.  Specifically, ***
7316 21 CFR 56.115(a)(4) 5 Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators.  Specifically, ***
7317 21 CFR 56.115(a)(1) 5 Copies of all research proposals and related documents Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects].  Specifically, ***
7459 21 CFR 312.57(a) 5 Records of receipt, shipment, disposition Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug.  Specifically, ***
3932 21 CFR 58.35(b)(6) 4 QAU: review final study report The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study.  Specifically, ***
3958 21 CFR 58.81(a) 4 SOPs: authorization and documentation of deviations Not all deviations from standard operating procedures in a study were authorized by the study director and  documented in the raw data.  Specifically, ***
4025 21 CFR 58.185(a)(9) 4 Final report: circumstances affecting data qual., integrity The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data.  Specifically, ***
7305 21 CFR 56.110(b)(2) 4 Minor changes The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature.  Specifically, ***
7333 21 CFR 56.104(c) 4 Emergency use and IRB approval A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal.  Specifically, ***
7369 21 CFR 56.109(h) 4 Children as subjects The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50 Subpart D, "Additional Safeguards for Children in Clinical Investigations."  Specifically, ***
7390 21 CFR 50.25(a)(4) 4 Alternate procedures, courses of treatment There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject.  Specifically, ***
7527 21 CFR 312.62(a) 4 Unused drug disposition (investigator) Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].  Specifically, *** 
7666 21 CFR 50.20 4 Understandable language The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative.  Specifically, ***
3918 21 CFR 58.33(a) 3 Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed.  Specifically, ***
3920 21 CFR 58.33(c) 3 Study director: unforeseen circumstances The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented.  Specifically, ***
3926 21 CFR 58.35(b)(1) 3 QAU: maintain a master schedule The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility.  Specifically, ***
3954 21 CFR 58.63(a) 3 Equipment: calibration Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized.  Specifically, ***
3960 21 CFR 58.81(b) 3 SOPs: required Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals].  Specifically, ***
3989 21 CFR 58.107 3 Test article: handling Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned].  Specifically, ***
4006 21 CFR 58.120(b) 3 Protocol: approval of changes Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated, and maintained with the protocol.  Specifically, ***
7319 21 CFR 56.115(a)(3) 3 Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities.  Specifically, ***
7320 21 CFR 56.109(e) 3 IRB approvals/disapprovals - general The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity.   Specifically, ***
7337 21 CFR 56.115(b) 3 Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research.  Specifically, ***
7339 21 CFR 56.108(a)(4) 3 Changes in approved research The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB approval had already been given, would not be initiated without IRB review and approval (except where necessary to eliminate apparent immediate hazards to the human subjects).  Specifically, ***
7340 21 CFR 56.108(a)(3) 3 Prompt reporting of changes The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity.  Specifically, ***
7363 21 CFR 50.55(f)  3 Documentation of permission by parents or guardian Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.  Specifically, ***
7388 21 CFR 50.25(a)(2) 3 Reasonably foreseeable risks or discomforts  The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.  Specifically, ***
7393 21 CFR 50.25(a)(8) 3 Participation; refusal and discontinuance The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled].  Specifically, ***
7507 21 CFR 312.52(a) 3 Transfer of obligations Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, ***
7543 21 CFR 312.61 3 Unauthorized recipients (investigator) A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator.   Specifically, ***
7657 21 CFR 50.25(b)(5) 3 Significant new findings The informed consent document did not include a statement that significant new findings developed during the course of the research, which might relate to the subject's willingness to continue participation, would be provided to the subject.  Specifically, ***
7664 21 CFR 50.20 3 Circumstances of obtaining consent The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence].  Specifically, ***
3909 21 CFR 58.31(a) 2 Management: designating the study director Testing facility management failed to designate a study director before each study was initiated.  Specifically, ***
3911 21 CFR 58.31(c) 2 Management: assure there is a QAU Testing facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations.  Specifically, ***
3919 21 CFR 58.33(b) 2 Study director: all data recorded and verified The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified.  Specifically, ***
3922 21 CFR 58.33(e) 2 Study director: follow GLP regulations The study director failed to assure that all applicable GLP regulations were followed.  Specifically, ***
3933 21 CFR 58.35(b)(7) 2 QAU: signed statement in final report The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director.  Specifically, ***
3952 21 CFR 58.61 2 Equipment: appropriate design and adequate capacity Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance.  Specifically, ***
3957 21 CFR 58.81(a) 2 SOPs: laboratory methods The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study.  Specifically, ***
3959 21 CFR 58.81(a) 2 SOPs: authorized changes Not all significant changes in established standard operating procedures were properly authorized in writing by management.  Specifically, ***
4016 21 CFR 58.185(a) 2 Final report: non-existent A final report was not prepared for each nonclinical laboratory study.  Specifically, ***
4021 21 CFR 58.185(a)(5) 2 Final report: stability of test and control articles The final study report did not include the stability of the test and control articles under the conditions of administration.  Specifically, ***
7274 21 CFR 56.107(a) 2 At least five members with varying backgrounds The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution].   Specifically, ***
7279 21 CFR 56.107(f) 2 Invited individual allowed to vote with IRB The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB.  Specifically, ***
7297 21 CFR 56.109(b) 2 Information given to subjects The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent.  Specifically, ***:
7353 21 CFR 50.52 2 Factors required for approval The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being.  However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55].  Specifically, ***
7370 21 CFR 56.111(c) 2 Children as subjects The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D.  Specifically, ***
7384 21 CFR 50.25(b)(1) 2 Statement of risks The informed consent document did not contain a statement that the test article or procedure might involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.  Specifically, ***
7387 21 CFR 50.25(a)(1) 2 Statement of research, purpose, duration of participation The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation].  Specifically, ***
7396 21 CFR 50.24(a)(3) 2 Prospect of direct benefit not determined In approving an investigation without requiring informed consent, the IRB did not [find] [document] that participation in the research held out the prospect of direct benefit to the subjects because [they faced a life-threatening situation requiring intervention] [evidence from preclinical studies supported the potential for intervention to provide a direct benefit to subjects] [associated risks were reasonable under the circumstances].  Specifically,***
7399 21 CFR 50.24(a)(7) 2 Additional protections of rights and welfare In approving an investigation without requiring informed consent, the IRB did not [find] [document] that additional protections of the rights and welfare of the subjects would be provided, including [consultation with, and public disclosure to, the communities in which the clinical investigation would be conducted, and from which the subjects would be drawn] [establishment of an independent data monitoring committee to exercise oversight of the clinical investigation] [attempting to contact (within the therapeutic window, when obtaining informed consent was not feasible and a legally authorized representative was not reasonably available) the subject's family member who was not a legally authorized representative, and asking whether he or she objected to the subject's participation in the clinical investigation].  Specifically,***
7406 21 CFR 56.109(a) 2 Scope of reviews The IRB does not review all research activities covered by the regulations.  Specifically, ***
7452 21 CFR 312.56(c) 2 IND safety report Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report.  Specifically, ***
7453 21 CFR 312.56(b) 2 Investigator non-compliance An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated].  Specifically, ***
7479 21 CFR 312.56(a) 2 Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND.  Specifically, ***
7488 21 CFR 312.59 2 Records of unused drug disposition Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57.  Specifically, ***
7531 21 CFR 312.62(c) 2 Record retention Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA].   Specifically, ***
7545 21 CFR 312.120(c) 2 Foreign clinical trials Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the ``Declaration of Helsinki''] [the laws and regulations of the country in which the research was conducted].  Specifically, ***
7629 21 CFR 312.56(c) 2 Annual report Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation.  Specifically, ***
7652 21 CFR 56.113 2 Reporting The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional officials] [the Food and Drug Administration].  Specifically, ***
7656 21 CFR 56.108(c) 2 Approval from a majority of members present For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present.  Specifically, ***
7660 21 CFR 50.24(a)(1) 2 IRB failed to find/document required conditions In approving an investigation without requiring informed consent, the IRB did not [find] [document] that [the human subjects were in a life-threatening situation] [available treatments were unproven or unsatisfactory] [the collection of valid scientific evidence was necessary to determine the safety and effectiveness of particular interventions].  Specifically, ***
3900 21 CFR 58.10 1 Notifying contractor of GLP status Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations.  Specifically, ***
3902 21 CFR 58.29(a) 1 Personnel: education, training, experience Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions.  Specifically, ***
3913 21 CFR 58.31(e) 1 Management: availability of resources Testing facility management failed to assure that all personnel, resources, facilities, equipment, materials, and methodologies were available as scheduled.  Specifically, ***
3915 21 CFR 58.31(g) 1 Management: QAU findings to study director Testing facility management failed to assure that any deviations from FDA GLP regulations reported by the quality assurance unit were communicated to the study director and corrective actions were taken and documented.  Specifically, ***
3925 21 CFR 58.35(a) 1 QAU: separate and independent The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study.  Specifically, ***
3931 21 CFR 58.35(b)(5) 1 QAU: authorize deviations from protocols or SOPs The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation.  Specifically, ***
3935 21 CFR 58.35(d) 1 QAU: access to SOPs, certify inspections  The quality assurance unit failed to provide access to the testing facility's written procedures for inspection of nonclinical laboratory studies.  Specifically, ***
3945 21 CFR 58.45 1 Facility: perishable supplies The testing facility does not provide appropriate storage areas for preservation of perishable supplies.  Specifically, ***
3949 21 CFR 58.47(b) 1 Facility: article storage separate from test system The testing facility does not provide storage areas for the test and control article and test and control mixtures [separate from areas housing the test systems] [adequate to preserve the identity, strength, purity, and stability of the articles and mixtures].  Specifically, ***
3955 21 CFR 58.63(b) 1 Equipment: maintenance SOPs The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate.  Specifically, ***
3976 21 CFR 58.90(f) 1 Animal care: cage and equipment cleaning Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals.  Specifically, ***
3977 21 CFR 58.90(g) 1 Animal care: analysis of feed and water Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol.  Specifically, ***
3983 21 CFR 58.105(a) 1 Test article: characterization The identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately defined and documented.  Specifically, ***
3988 21 CFR 58.105(d) 1 Test article: reserve sample retention Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks' duration were retained for the required period of time.  Specifically, ***
3996 21 CFR 58.120(a)(3)  1 Protocol: sponsor name and address Not all protocols contained the name of the sponsor and the name and address of the testing facility at which the study is being conducted.  Specifically, ***
4008 21 CFR 58.130(b) 1 Conduct: test systems monitoring Not all test systems were monitored in conformity with the protocol.  Specifically, ***
4009 21 CFR 58.130(c) 1 Conduct: identification of test specimens Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data.  Specifically, ***
4011 21 CFR 58.130(e) 1 Conduct: recording in ink Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink.  Specifically, ***
4012 21 CFR 58.130(e) 1 Conduct: date and sign Not all data entries were dated on the date of entry and signed or initialed by the person entering the data.  Specifically, ***
4013 21 CFR 58.130(e) 1 Conduct: changes not obscuring original entries Not all changes in entries were made so as not to obscure the original entry, indicated the reason for such change, and were dated and signed or identified at the time of the change.  Specifically, ***
4018 21 CFR 58.185(a)(2) 1 Final report: objectives, procedures, changes The final study report did not include the objectives and procedures stated in the approved protocol, including any changes in the original protocol.  Specifically, ***
4024 21 CFR 58.185(a)(8) 1 Final report: dosage, regimen, route of admin., duration The final study report did not include a description of the dosage, dosage regimen, route of administration, and duration.  Specifically, ***
4026 21 CFR 58.185(a)(10) 1 Final report: names of those involved The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study.  Specifically, ***
4028 21 CFR 58.185(a)(12) 1 Final report: reports of individual scientists The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study.  Specifically, ***
4035 21 CFR 58.190(a) 1 Archives: data, documentation, specimens Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained.  Specifically, ***
4039 21 CFR 58.190(c) 1 Archives: individual responsible An individual was not identified as responsible for the archives.  Specifically, ***
4041 21 CFR 58.190(e) 1 Archives: indexing, expedient retrieval Not all material retained or referred to in the archives was indexed to permit expedient retrieval. Specifically, ***
4042 21 CFR 58.195(b) 1 Archives: retention for appropriate time Not all required documentation records, raw data, and specimens pertaining to a nonclinical laboratory study were retained in the archives for the appropriate time.  Specifically, ***
4045 21 CFR 58.195(e) 1 Archives: retention of summaries of training, et. al. Not all required summaries of training and experience and job descriptions were retained for the required period of time.  Specifically, ***
4047 21 CFR 58.195(g) 1 Archives: records not retained as originals, true copies Not all required records were retained as original records or as true copies of the original records.  Specifically, ***
4049 21 CFR 58.195(h) 1 Archives: notification of FDA of transfer The Food and Drug Administration was not notified in writing of the transfer of all raw data, documentation, and other required material pertaining to a nonclinical laboratory study when the laboratory facility went out of business.  Specifically, ***
7270 21 CFR 56.103(a) 1 IRB review requirement A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review].  Specifically, ***
7276 21 CFR 56.107(c) 1 One scientific and one non-scientific member The IRB does not include [at least one member whose primary concerns are in the scientific area] [at least one member whose primary concerns are in nonscientific areas].  Specifically, ***
7292 21 CFR 56.109(g) 1 Providing publicly-disclosed information to sponsor The IRB has not [promptly] provided to the sponsor of research involving an exception to informed consent a copy of information that has been publicly disclosed by regulation.  Specifically, ***
7309 21 CFR 56.111(a)(1) 1 Risks minimized by sound research design The IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were consistent with sound research design and which did not unnecessarily expose subjects to risk.  Specifically, ***
7322 21 CFR 56.111 (a)(2) 1 Risks to subjects reasonable The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result.  Specifically, ***
7325 21 CFR 56.111(a)(5) 1 Informed consent documented The IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented.  Specifically, ***
7328 21 CFR 56.111(b) 1 Vulnerable subject safeguards The IRB approved the conduct of research in a situation where some or all of the subjects were likely to be vulnerable to coercion or undue influence, but did not determine that additional safeguards had been included in the study to protect the rights and welfare of those subjects.  Specifically, ***
7336 21 CFR 56.115(a)(7) 1 Statements of significant new findings Documentation has not been [prepared] [maintained] of all statements of significant new findings provided to subjects, as required by 21 CFR 50.25.  Specifically, ***
7354 21 CFR 50.53 1 Factors required for approval The IRB approved a study in which more than minimal risk to children was presented by [an intervention or procedure that did not hold out the prospect of direct benefit for the subjects] [a monitoring procedure that was not likely to contribute to the well-being of the subjects].  However, the IRB did not [find] [document] that [the risk represented a minor increase over minimal risk] [the intervention or procedure presented experiences to subjects that were reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations] [the intervention or procedure was likely to yield generalizable knowledge about the subjects' disorder or condition that was of vital importance for the understanding or amelioration of the subjects' disorder or condition] [adequate provisions had been made for soliciting the assent of the children and permission of their parents or guardians].  Specifically, ***
7374 21 CFR 56.109(c)(2) 1 Exception from informed consent; emergency research The IRB waived the requirement for a written consent form signed by the [subject] [subject's legally authorized representative], without first determining that the requirements in 21 CFR 50.24 for an exception from informed consent for emergency research were met.  Specifically, ***
7389 21 CFR 50.25(a)(3) 1 Benefits to the subject A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document.  Specifically, ***
7394 21 CFR 50.24(a)(2) 1 No determination that obtaining IC wasn't feasible In approving an investigation without requiring informed consent, the IRB did not [find] [document] that obtaining informed consent was not feasible.  Specifically,***
7397 21 CFR 50.24(a)(5) 1 Not contacting reps within potential therapeutic window In approving an investigation without requiring informed consent, the IRB did not [find] [document] that the proposed investigational plan defined the length of the potential therapeutic window based on scientific evidence, and the investigator had committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative for consent within that window rather than proceeding without consent.  Specifically,***
7398 21 CFR 50.24(a)(6) 1 No determination that IC procedure/document were approved In approving an investigation without requiring informed consent, the IRB did not [find] [document] that appropriate informed consent procedures and an informed consent document consistent with 21 CFR 50.25 were in place for use [with subjects or their legally authorized representatives in situations where use of such procedures and documents was feasible] [when providing an opportunity for a family member to object to a subject's participation in the clinical investigation].  Specifically,***
7410 21 CFR 312.53(a) 1 Investigator selection Investigators who were not qualified by training and experience as appropriate experts were selected to investigate a drug.  Specifically, ***
7428 21 CFR 312.53(c)(2) 1 Investigator CV or other statement of qualifications Failure to obtain a curriculum vitae or other statement of the qualifications of the investigator, before permitting an investigator to participate in an investigation.  Specifically, ***
7518 21 CFR 312.64(d) 1 Financial info Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor.  Specifically, ***
7519 21 CFR 312.64(c) 1 Final study report An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.   Specifically, ***
7534 21 CFR 312.68 1 FDA access to clinical investigator records Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports.  Specifically, ***
7555 21 CFR 312.53(d) 1 Selecting monitors Monitors not qualified by experience and training were selected to monitor the progress of a clinical investigation.   Specifically, ***
7557 21 CFR 312.56(b) 1 Notification of FDA of termination of investigator Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation.  Specifically, ***
7558 21 CFR 312.57(c) 1 Record retention requirement Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically***
7631 21 CFR 312.53(c)(4) 1 Financial information - commitment to update Failure to obtain from an investigator a commitment to update financial information, to allow complete and accurate certification or disclosure statements.   Specifically, ***
7638 21 CFR 312.20(a) 1 Failure to submit an IND The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***
7679 21 CFR 56.106(a) 1 IRB for CI's in support of research/marketing permits An individual authorized to act on behalf of an IRB which reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products has not submitted registration information.  Specifically, ***

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Veterinary medicine

Center Name Cite Id Ref No Frequency Short Description Long Description
Veterinary medicine 4185 FDCA 402(a)(4) 155 Record keeping Treatment records were not [maintained] [complete].  Specifically,*** 
4093 21 CFR 530.11(d) 98 Tissue residue Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling.  Specifically, ***
7001 FDCA 402(a)(4) 98 Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock].  Specifically, ***
4182 FDCA 501(a)(5) 48 Extra label use w/o veterinary client-patient relationship Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship.  Specifically, ***
1360 FDCA 501(a)(5) 33 Expired drugs Expired drug(s) were observed in the drug storage area.  Specifically, ***
4097 21 CFR 530.20(a)(2)(iv) 31 Tissue residue Causing an illegal residue in a food-producing animal of an approved human or animal drug through [prescribing the use of] [using] the drug contrary to its labeling, and failing to take appropriate measures to assure that [assigned timeframes for withdrawal were met] [no illegal residue would occur].  Specifically, ***
13509 FDCA 402(a)(4) 28 Identity of animals Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the animal(s) that you [purchased] [transported] and delivered for [sale] [consignment] at [an auction yard] [a slaughter plant].  Specifically, ***
4298 21 CFR 530.11(a) 26 Rx not followed Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment] [route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary directions].  Specifically, ***
13521 21 CFR 530.41(a) 25 Drugs prohibited for extralabel use in food producing animal A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing animal(s).  Specifically, ***
1442 FDCA 402(a)(4) 22 Records review prior to slaughter Failure to systematically review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed.  Specifically, ***
4186 FDCA 402(a)(4) 22 System for administration of drugs Failure to have a system to control administration of drug treatments to your animals.  Specifically, ***
1389 21 CFR 530.11(a) 18 Withdrawal period Administration of an approved animal drug contrary to the labeling, without benefit of a valid veterinarian-client-patient relationship, in that pre-slaughter withdrawal time was not observed.  Specifically, ***
13508 FDCA 402(a)(4) 14 Medication status of animals  Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and delivered for [sale] [consignment] at  [an auction yard] [a slaughter plant].  Specifically, ***
4184 FDCA 501(a)(5) 13 Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, ***
1362 21 CFR 530.11(a) 11 Species or class Administration of an approved human or animal drug to a [species of animal] [class of animal] for which the drug was not labeled, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
1366 21 CFR 530.11(a) 10 Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
1446 FDCA 402(a)(4) 9 Hospital pen Failure to [identify] [segregate] [quarantine] treated animals.  Specifically, ***
4545 21 CFR 225.120 9 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation.  Specifically, ***
1811 21 CFR 225.58(b)(1) 8 Three assays per year Periodic assays are not performed during the calendar year on at least three representative samples of medicated feeds requiring a medicated feed mill license, for each drug or drug combination used.  Specifically, ***
4560 21 CFR 225.165 8 Establishment and use of adequate procedures Adequate procedures are not [established] [used] for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds.  Specifically, ***
1457 FDCA 402(a)(4) 7 Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, ***
1373 21 CFR 530.11(a) 6 Route of administration Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous] [subcutaneous] [topical] [intramammary] [intrauterine], which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
1469 21 CFR 225.20(b)(3) 6 Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  Specifically, ***
4099 21 CFR 530.20(a)(2)(ii) 6 Extended withdrawal period A substantially extended withdrawal period, supported by appropriate scientific information, was not established for the use of an approved drug in a food-producing animal, in an extralabel manner.  Specifically, ***
1850 21 CFR 225.58(d) 5 Assay results out of specification Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective action] when assay results show medicated feeds [not in accord with label specifications] [not within permissible assay limits].  Specifically,***
2075 21 CFR 225.102(b)(1) 5 Preparation of MRF A  Master Record File providing the complete procedure for manufacturing a specific product  is not [prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***
4098 21 CFR 530.20(a)(2)(i) 5 Diagnosis and evaluation of conditions Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or animal drug was to be used in a food-producing animal, contrary to the drug's labeling.  Specifically, ***
4111 21 CFR 530.12(c) 5 Directions for use Failure to provide labeling containing directions for use as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
1491 21 CFR 225.30(b)(2) 4 Maintenance reasonably clean & orderly Equipment is not  maintained in a reasonably clean and orderly manner.  Specifically, ***
1760 21 CFR 225.42(b)(6) 4 Lot number or shipment I.D. number The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification number].  Specifically, ***
2097 21 CFR 225.102(b)(4) 4 Daily review of production records The batch production records are not checked by a responsible individual at the end of the working day to determine whether all required production steps have been performed.  Specifically, ***
4113 21 CFR 530.12(e) 4 Withdrawal, withholding, or discard time Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
4552 21 CFR 225.142 4 Adequate procedures for Type A and Type B articles Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory control (receipt and use)] of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds.  Specifically, ***
13534 21 CFR 511.1(b)(7)(ii) 4 Records: Maintenance Complete records of the investigation were not maintained.  Specifically, ***
1262 21 CFR 225.10(b)(2) 3 Evaluation and supervision of employees Failure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds.  Specifically, ***
1376 21 CFR 530.11(a) 3 Frequency and duration Administration of an approved animal drug [more frequently] [for a longer time period] than specified in the labeling, without benefit of a valid veterinarian-client-patient relationship.  Specifically, ***
1466 21 CFR 225.20(b)(2) 3 Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner.  Specifically, ***
1493 21 CFR 225.30(b)(4) 3 Calibration of scales and metering devices Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation] [as frequently as necessary] to insure their accuracy.  Specifically, ***
1744 21 CFR 225.42(b)(6) 3 Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.  Specifically, ***
4131 21 CFR 589.2000(c)(1)(i) 3 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants."  Specifically, ***
4132 21 CFR 589.2000(d)(1) 3 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."  Specifically, ***
4137 21 CFR 589.2000(d)(1) 3 Maintaining records Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution.  Specifically, ***
4183 FDCA 501(a)(5) 3 Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].  Specifically, ***
4553 21 CFR 225.142 3 Packaged Type A and Type B designated areas The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers].  Specifically, ***
13541 FDCA 501(a)(5) 3 Use of veterinary prescription drugs without a prescription Administration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. Specifically, ***
1575 21 CFR 225.42(b)(4) 2 Integrity and identity Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity.  Specifically, ***
1638 21 CFR 225.42(b)(5) 2 Elements of receipt record Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's lot number or other identifying number] [date of receipt] [condition of the drug when received] [return of any damaged drugs] for each lot of drug received.  Specifically, ***
1765 21 CFR 225.42(b)(6)(i) - (v) 2 Information required Daily inventory records for each drug used do not include [the quantity of drug on hand at the beginning and end of the work day] [the amount of each drug used, sold, or otherwise disposed of] [the batches or production runs of medicated feed in which each drug was used] [information concerning any semiprocessed intermediate mix to be used in a medicated feed] [the action taken to reconcile any discrepancies in the inventory record].  Specifically, ***  
1782 21 CFR 225.42(b)(7) 2 Daily comparison, actual vs theoretical A daily comparison is not made between the actual amount of drug used and the theoretical amount of drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds manufactured.  Specifically, ***
1821 21 CFR 225.58(b)(1) 2 First batch assay No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license.  Specifically, ***
1923 21 CFR 225.65(b) 2 Reasonable and effective procedures followed All equipment that comes in contact with [active drug components] [feeds in process] [finished medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed.  Specifically, ***
1952 21 CFR 225.80(b)(2) 2 Proofreading labels, labeling, placards Incoming  [labels] [labeling] [placards] are not proofread upon receipt from the printer against the Master Record Files  to verify suitability and accuracy.  Specifically, ***
1955 21 CFR 225.80(a) 2 Appropriate labeling for medicated feed Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the article is safe and effective for its intended purpose.  Specifically, ***
2076 21 CFR 225.102(b)(1) 2 Elements of the MRF The Master Record File does not contain [the name of the medicated feed] [the name and weight percentage or measure of each drug or drug combination and each nondrug ingredient to be used in manufacturing a stated weight of medicated feed] [a copy or description of the label that will accompany the medicated feed] [manufacturing instructions or reference thereto that have been determined to yield a properly mixed medicated feed of the specified formula for each medicated feed produced]  [appropriate control directions including the collection of samples for specified laboratory assays] [the basis for estimating quantity produced, where actual yield cannot be accurately determined when finished feed is stored in bulk].  Specifically, ***
2093 21 CFR 225.102(b)(2)(i)-(iv) 2 Elements of production record(s) Production record(s) fail to include [the product identification] [the date of production] [a written endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of drug components used] [the theoretical quantity of medicated feed to be produced] [the actual quantity of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based on the basis for the estimate in the MRF].  Specifically, ***
4094 21 CFR 530.11(b) 2 Use in animal feed An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
4108 21 CFR 530.12(a) 2 Name and address - drug dispensed by veterinarian Failure to provide labeling showing the name and address of the prescribing veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
4112 21 CFR 530.12(d) 2 Cautionary statements Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, ***
4541 21 CFR 225.42(b) 2 Adequate procedures established Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid in assuring their identity, strength, quality and purity when incorporated into products.  Specifically, ***
4547 21 CFR 225.130 2 Cleanliness, inspection, cleanout  Equipment for producing medicated feeds of intended potency and purity is not [maintained in a reasonably clean and orderly manner] [designed, constructed, installed and maintained so as to facilitate inspection and use of cleanout procedures].  Specifically, ***
4555 21 CFR 225.142 2 Use in accord with directions All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions.  Specifically, ***
4567 21 CFR 225.202 2 Facilitation of recall The [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  Specifically, *** 
13532 21 CFR 511.1(b)(7)(ii) 2 Records: Test article accountability Complete records of the receipt and disposition of each shipment or delivery of the test article were not maintained by the investigator.  Specifically, ***
1465 21 CFR 225.20(b)(1) 1 Building grounds maintenance The building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass] [improperly stored equipment].  Specifically, ***
1482 21 CFR 225.30(b)(1) 1 Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity].  Specifically, ***
1535 21 CFR 225.42(b)(2) 1 Storage of packaged drugs Packaged drugs are not stored  in their original closed containers.  Specifically, ***
1539 21 CFR 225.42(b)(3) 1 Identification and storage of bulk drugs Bulk drugs are not [identified] [stored] in a manner such that their identity, strength, quality, and purity will be maintained.  Specifically, ***
1634 21 CFR 225.42(b)(5) 1 Receipt for each lot of drug received Failure to [prepare] [maintain] a receipt record for each lot of drug received.  Specifically, ***
1880 21 CFR 225.58(e) 1 Distribution discontinued Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued.  Specifically, ***
1882 21 CFR 225.58(e) 1 Subsequent production Following distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feed  was resumed prior to the establishment of proper control procedures.  Specifically, ***
1925 21 CFR 225.65(b)(2) 1 Flush material handling Material used for cleanout by flushing is not properly [identified] [stored] [used in a manner] to prevent unsafe contamination of other feeds.  Specifically, ***
2074 21 CFR 225.102(a) 1 Lack of MRF Failure to have a  Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a specific product.  Specifically, ***
2091 21 CFR 225.102(b)(2) 1 Preparation of Production Records The production record  is not prepared by qualified personnel for each batch or run of medicated feed. Specifically, ***
2232 21 CFR 225.115(b)(1) 1 Maintaining records of complaints The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is not maintained on the premises.  Specifically, ***
2233 21 CFR 225.115(b)(1) 1 Records of oral or written complaints The record of each oral or written complaint relating to the safety and effectiveness of a  medicated feed  fails to include the [date of the complaint] [complainant's name] [complainant's address] [name and lot or control number or date of manufacture] [specific details of the complaint] [correspondence from the complainant and/or memoranda of conversations] [description of all investigations made by the manufacturer] [method of disposition of the complaint]. Specifically, ***
2352 21 CFR 226.58(a) 1 Specifications, test procedures - components Laboratory controls do not include adequate specifications and test procedures to assure that drug components used in the manufacture of Type A medicated articles conform to appropriate specifications.  Specifically, ***
2359 21 CFR 226.58(e) 1 Test method reliability Laboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures. Specifically, ***
4100 21 CFR 530.20(a)(2)(iii) 1 Identity of treated animals Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed or dispensed an approved human or animal drug contrary to the drug's labeling.  Specifically, ***
4101 21 CFR 530.20(a)(1) 1 Approved drug available Failure to determine that an approved animal drug was clinically ineffective for its intended use in a food-producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the drug's labeling.  Specifically, ***
4115 21 CFR 530.13(a) 1 From bulk drugs Compounding an animal drug from a bulk drug.  Specifically, ***
4118 21 CFR 530.13(b)(3) 1 Outside of scope of professional practice Compounding  of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the scope of a professional practice.  Specifically, ***
4119 21 CFR 530.13(b)(4) 1 Inadequate procedures and processes Failure to follow adequate procedures and processes to ensure the safety and effectiveness of a compounded animal drug.  Specifically, ***
4146 21 CFR 589.2000(e)(1) 1 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants.  Specifically, ***
4147 21 CFR 589.2000(e)(1) 1 Written product separation procedures Failure to maintain procedures for separating products which may contain protein derived from mammalian tissues from all other protein products, from the time of receipt until the time of shipment.  Specifically, ***
4166 21 CFR 226.102(a)(5) 1 Master formula records do not have... Master-formula records for Type A medicated articles do not include [control instructions] [procedures] [specifications] [special notations] [precautions] to be followed.  Specifically, ***

 
4453 21 CFR 225.10(b)(1) 1 Employees lack understanding All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment].  Specifically, ***
4544 21 CFR 225.120 1 Buildings--space and access Buildings for the production of medicated feed lack adequate space for [equipment] [processing] [orderly receipt and storage of medicated feed] [access to equipment for routine maintenance and cleaning].  Specifically, ***
4548 21 CFR 225.130 1 Scales and metering devices The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose.  Specifically, ***
4554 21 CFR 225.142 1 Bulk Type A and Type B storage Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality and purity will be maintained.  Specifically, *** 
4564 21 CFR 225.180 1 Bagged or bulk deliveries All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used.  Specifically, ***
4569 21 CFR 225.202 1 Records kept one year Records identifying the formulation, date of mixing, and date of shipment (if not for own use) are not retained on the premises for one year following the date of last distribution.  Specifically, ***
13524 21 CFR 511.1(b)(8)(iv) 1 Medical claims Representations were made that the new animal drug under investigation is [safe][effective].  Specifically, ***
13526 21 CFR 511.1(b)(8)(ii) 1 Sponsor/CRO: Reporting of hazards The [sponsor][CRO] failed to promptly investigate and report to the FDA and investigators any  findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the drug.  Specifically, ***
13528 21 CFR 511.1(b)(8)(ii) 1 Sponsor: Monitoring The [sponsor][CRO] did not provide for current monitoring of the investigation by a qualified person.  Specifically, ***
13531 21 CFR 511.1(b)(7)(iii) 1 Reports: Adequate and Timely The investigator did not furnish adequate and timely reports of the investigation to the sponsor.  Specifically, ***
13535 21 CFR 511.1(b)(7)(i) 1 Sponsor/CRO: education, training, experience The [sponsor][CRO] did not assure that the new animal drug was shipped only to investigators who have the scientific training and/or experience to evaluate the safety and/or effectiveness of the drug.   Specifically, ***
13539 21 CFR 511.1(b)(4) 1 No NCIE submitted A Notice of Claimed Investigational Exemption for a New Animal Drug (NCIE) was not submitted prior to the shipment of that drug for clinical testing.  Specifically, ***
13567 21 CFR 589.2001(c)(2)(iv) 1 Label "Do not feed to animals" Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals".  Specifically,***
13568 21 CFR 589.2001(c)(2)(v) 1 Marking with readily detected agent Failure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with an agent that can be readily detected on visual inspection.  Specifically,***

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Biologics

Center Name Cite Id Ref No Frequency Short Description Long Description
Biologics 76 21 CFR 606.100(b) 135 Maintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises].  Specifically, ***
98 21 CFR 606.100(c) 51 Thorough investigations Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications].  Specifically,***
 
155 21 CFR 606.160(b) 33 Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  Specifically, ***
9225 21 CFR 606.171 31 Biological product deviation report Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred].  Specifically, ***
160 21 CFR 606.160(a)(1) 30 Person performing, test results, interpretation Records fail to [identify the person performing the work] [include dates of the various entries] [show test results] [include interpretation of the results] [show the expiration date assigned to specific products] [be as detailed as necessary] so as to provide a complete history of the work performed.  Specifically, ***
31 21 CFR 606.20(b) 28 Qualifications of responsible personnel The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components are not adequate in [number] [educational background] [training and experience, including professional training as necessary]  to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.  Specifically, ***
154 21 CFR 606.160(a)(1) 26 Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the [collection] [processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components so that all steps can be clearly traced.  Specifically, ***
67 21 CFR 606.65(e) 19 Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.  Specifically, ***
4425 21 CFR 606.60(a) 16 Equipment observed, standardized, calibrated Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as prescribed in the SOP Manual.  Specifically, ***
78 21 CFR 606.100(c) 14 Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.  Specifically, ***
159 21 CFR 606.160(a)(1) 14 Legibility and indelibility Records are [illegible] [not indelible].  Specifically, ***
12202 21 CFR 606.170(a) 14 Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.  Specifically,
15030 21 CFR 606.60(b) 12 Equipment calibration frequency Equipment used in the [collection][processing][compatibility testing][storage and distribution] of blood and blood components is not observed, standardized and calibrated with at least the frequency required.  Specifically, ***
57 21 CFR 606.60(a) 11 Maintain and clean equipment Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood products [in a clean and orderly manner] [so as to facilitate cleaning and maintenance].  Specifically, ***
208 21 CFR 640.3(a)(1) 10 Donor suitability procedures not followed  Failure to [follow] [maintain] [maintain on the premises] standard procedures and methods for determining the suitability of a donor as a source of blood.  Specifically, ***
158 21 CFR 606.160(e) 8 Unsuitable donors A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed.  Specifically, ***
9044 21 CFR 600.10(b) 8 Personnel capabilities Failure to assure that personnel have [capabilities commensurate with] [the necessary training in] [necessary experience in] [a thorough understanding of] the operations which they perform.  Specifically, ***
9243 21 CFR 630.6(a) 8 Notification Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on suitability criteria].  Specifically, ***
41 21 CFR 606.40(a)(1) 7 Provide space for examination Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors.  Specifically, ***
89 21 CFR 606.100(b)(10) 7 Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents  Specifically, ***
224 21 CFR 640.4(f) 7 Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.  Specifically, ***
9220 21 CFR 606.100(b)(20) 7 Donor notification The standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial attempt at donor notification fails].  Specifically, ***
12203 21 CFR 606.170(a) 7 Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.  Specifically, 
61 21 CFR 606.60(a) 5 Provide proper equipment to meet requirements Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606.  Specifically, ***
77 21 CFR 606.100(b) 5 Written SOPs available for use by personnel Failure to make available written procedures for use by personnel in the areas where the procedures are performed.  Specifically, ***
80 21 CFR 606.100(b)(1) 5 Donor criteria The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria.  Specifically, ***
94 21 CFR 606.100(b)(15) 5 Schedules and procedures for equipment & calibration The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.  Specifically, ***
161 21 CFR 606.160(a)(2) 5 Determination of lot numbers and supplies Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product.  Specifically, ***
9089 21 CFR 600.14(c) 5 When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.  Specifically, *** 
9596 21 CFR 640.3(a) 5 Donor suitability by means of medical history Failure to [always] determine donor suitability on the day of collection by means of [medical history] [test for hemoglobin level] [physical examination].  Specifically, ***
35 21 CFR 606.40 4 Clean & orderly Failure to maintain facilities in a clean and orderly manner.  Specifically, ***
93 21 CFR 606.100(b)(14) 4 QC procedures for supplies and reagents The standard operating procedure fails to include a written description of the quality control procedures for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing].  Specifically, ***
246 21 CFR 640.25(a) 4 Storage temps./agitation Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius].  Specifically, ***
9234 21 CFR 630.6(c) 4 Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation.  Specifically, ***
9238 21 CFR 630.6(b)(3) 4 Results of testing Failure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral] [supplemental tests].   Specifically, ***
63 21 CFR 606.65 3 Safe, sanitary, orderly storage Failure to store all supplies and reagents used in the [collection]  [processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner.  Specifically, ***
75 21 CFR 606.100(a) 3 SOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.  Specifically, ***
88 21 CFR 606.100(b)(9) 3 Written methods for investigating adverse reactions The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions.  Specifically, ***
117 21 CFR 606.121(f) 3 Labeling of blood products unsuitable for transfusion Failure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with ["NOT FOR TRANSFUSION"] [the reason the unit is considered unsuitable].  Specifically, ***
142 21 CFR 606.140(a) 3 Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.  Specifically, ***
150 21 CFR 606.151(e) 3 Procedures to maintain records of emergency transfusions Records [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including complete documentation justifying the emergency action].  Specifically, ***
157 21 CFR 606.160(d) 3 Retention period Failure to retain records [for 5 years after the  records of processing have been completed] [for 6 months after the latest expiration date for the individual product] [indefinitely where there is no expiration date].  Specifically, ***
162 21 CFR 606.165(a) 3 Distribution and receipt - recalls Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall.  Specifically, ***
165 21 CFR 606.170(a) 3 Adverse reaction - Maintenance of Reports Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of [blood collection] [transfusion].  Specifically, ***
205 21 CFR 640.3(f) 3 Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b).  Specifically, ***
212 21 CFR 640.3(b)(3) 3 Qualifications of donor - hemoglobin Each  donor was not in good health as indicated in part by the blood hemoglobin level which was demonstrated to be less than 12.5 gm. of hemoglobin per 100 ml of blood (38% by microhematocrit).  Specifically, ***
225 21 CFR 640.4(f) 3 Closed system The blood is [not collected by aseptic methods in a sterile system] [collected using a vented system which fails to protect the blood against contamination].  Specifically, ***
227 21 CFR 640.4(h) 3 Storage temperatures after collection After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius] [transported from the donor clinic to the processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius].  Specifically, ***
251 21 CFR 640.25(b) 3 Quality control Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for [platelet count] [pH of not less than 6.0 measured at the storage temperature of the unit] [actual plasma volume].  Specifically, ***
333 21 CFR 640.64(e) 3 Prevention of contamination The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood.  Specifically, ***
3443 21 CFR 610.47 3 Notification of transfusion recipients Failure to [notify the attending physician of a recipient of a lookback unit] [make a minimum of three attempts within 8 weeks to notify the recipient of a lookback unit in the event the physician does not inform the recipient] [notify recipient's legal representative or relative] [document notifications of lookback units].  Specifically, ***
9086 21 CFR 600.14(a)(1) 3 Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports].  Specifically, ***
9219 21 CFR 606.100(b)(20) 3 Donor deferral The standard operating procedure fails to include a written description of the donor deferral process.  Specifically, ***
9236 21 CFR 630.6(b)(1) 3 Deferred or not suitable Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral].  Specifically, ***
9241 21 CFR 630.6(a) 3 Supplemental results Failure to [attempt to obtain the results of supplemental testing prior to notifying a donor of a deferral] [notify a donor of the results of supplemental testing].  Specifically, ***
9271 21 CFR 610.41 3 Donor Deferral - reentry The method or process used to requalify deferred donors was not found acceptable for such purposes by FDA.  Specifically, ***
42 21 CFR 606.40(a)(2) 2 Provide space for blood withdrawal Failure to provide adequate space for the withdrawal of blood from donors with minimal [risk of contamination] [exposure to activities and equipment unrelated to blood collection].  Specifically, ***
50 21 CFR 606.40(c) 2 Provide adequate handwashing Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel.  Specifically, ***
51 21 CFR 606.40(c) 2 Provide adequate toilet facilities Failure to provide [adequate] [clean] [convenient] toilet facilities for donors and personnel.   Specifically, ***
54 21 CFR 606.40(d)(2) 2 Provide adequate disposal of blood & blood components Failure to provide for safe and sanitary disposal for blood and blood components not suitable for use or distribution.  Specifically, ***
86 21 CFR 606.100(b)(7) 2 Methods for performance of all tests The standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood components during processing.  Specifically, ***
156 21 CFR 606.160(c) 2 Assignment of donor number Failure of records describing the history and ultimate disposition of blood products to include a donor number [assigned to each accepted donor] [which relates to the unit of blood collected from that donor] [which relates to the donor's medical record] [which relates to any component or blood product from the donor's unit of blood].  Specifically, ***
167 21 CFR 606.170(b) 2 Adverse reaction - fatality A confirmed, fatal complication of [blood collection] [transfusion]  was not [reported as soon as possible] [submitted in writing within 7 days after the fatality] to the Director, Office of Compliance, Center for Biologics Evaluation and Research by the [collecting facility in the event of a donor reaction] [facility that performed the compatibility tests in the event of a transfusion reaction].  Specifically, ***
215 21 CFR 640.3(b)(6) 2 Qualifications of donor - disease transmissible by blood Failure to determine whether each donor is free from any disease transmissible by blood as determined by history and examinations.  Specifically, ***
236 21 CFR 640.5(e) 2 Testing - inspection Failure to [visually inspect blood during storage and immediately prior to issue for] [prevent issuance of blood found to have] abnormal color, physical appearance, or indication or suspicion of microbial contamination.  Specifically, ***
255 21 CFR 640.31 2 Donor suitability Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria.  Specifically, ***
376 21 CFR 640.120 2 Alternative procedures Failure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components] [blood products].  Specifically, ***
3244 21 CFR 640.61 2 Written consent Failure to obtain written consent of prospective Source Plasma donors.  Specifically, ***
9052 21 CFR 600.11(b) 2 Equipment  There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use].  Specifically, ***
9078 21 CFR 600.12(a) 2 Maintenance  - tracing Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product to be traced.  Specifically, ***
9227 21 CFR 606.171(a) 2 BPDR - procedures Failure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor.  Specifically, ***
9235 21 CFR 630.6(c) 2 Documentation Failure to [document that you have successfully notified a deferred donor] [document that you have made reasonable attempts to notify a deferred donor].  Specifically, ***
43 21 CFR 606.40(a)(3) 1 Provide space for storage of blood & blood products Failure to provide adequate space for the storage of blood or blood components pending completion of tests.  Specifically, ***
 
45 21 CFR 606.40(a)(5) 1 Provide space for storage of finished product Failure to provide adequate space for the storage of finished products prior to distribution.  Specifically, ***
46 21 CFR 606.40(a)(6) 1 Provide space for quarantine of unsuitable for use items Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use.  Specifically, ***
49 21 CFR 606.40(a)(9) 1 Provide space for all packaging, labeling, & finishing ops. Failure to provide adequate space for the orderly conduction of all [packaging] [labeling] [other finishing] operations.  Specifically, ***
64 21 CFR 606.65(b) 1 Visual examination Failure to inspect each blood collecting container [and its satellite container(s)] for damage or evidence of contamination including breakage of seals and abnormal discoloration [prior to its use] [immediately after filling].  Specifically, ***
81 21 CFR 606.100(b)(2) 1 Donor qualifying tests & measurements The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining acceptability.  Specifically, ***
84 21 CFR 606.100(b)(5) 1 Accurate measurement of quantity of blood The standard operating procedure fails to include a written description of the blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood removed from the donor.  Specifically, ***
105 21 CFR 606.122 1 Instruction circular - required information Failure to provide an instruction circular for products intended for transfusion containing adequate directions for use and the information contained in 21 CFR 606.122.  Specifically, ***
121 21 CFR 606.121(c)(2) 1 Name, address, registration number The container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed product].  Specifically, ***
137 21 CFR 606.121(c)(13) 1 Unapproved encoded/machine readable information The container label bears encoded information in the form of machine-readable symbols which have not been approved for use by the Director, Center for Biologics Evaluation and Research).  Specifically, ***
143 21 CFR 606.140(b) 1 Provisions to monitor lab test procedures & instruments Failure to establish  adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments.  Specifically, ***
147 21 CFR 606.151(d) 1 Crossmatching of donor/recipient cells Failure of standard operating procedures for compatibility testing to include the testing of the donor’s cells with the recipient’s serum (minor crossmatch) by a method that will demonstrate agglutinating, coating and hemolytic antibodies.  Specifically, ***
164 21 CFR 606.165(c) 1 Receipt records - content Receipt records fail to contain the [name and address of the collecting facility] [date received] [donor or lot number assigned by the collecting facility] [date of expiration or the date of collection, whichever is applicable]  Specifically, ***
198 21 CFR 640.2(c)(3) 1 Blood not stored between 1-6 deg / shipped 1-10 deg Reissued blood has not been [stored continuously at 1 to 6 C] [shipped between 1 and 10 C].  Specifically, ***
203 21 CFR 640.3(d) 1 Therapeutic bleedings Blood is used as a source of Whole Blood which was withdrawn in order to promote the health of a donor otherwise qualified and the container label failed to conspicuously indicate the donor's disease that necessitated withdrawal of blood.  Specifically, ***
233 21 CFR 640.5(b) 1 Testing - ABO Failure to test blood for determination of ABO blood group [using two blood group tests] [using appropriate reagents] [using appropriate techniques].  Specifically, ***
247 21 CFR 640.24(b) 1 Storage until removal of platelets Failure to hold [whole blood] [plasma] immediately after collection between 20 and 24 degrees Celsius until the platelets are separated.  Specifically, ***
253 21 CFR 640.25(b)(4) 1 Corrective action Failure to [take immediate corrective action] [maintain a record of corrective action] when the quality control testing for platelets does not meet the prescribed requirements.  Specifically, ***
270 21 CFR 640.34(b) 1 Fresh Frozen Plasma - preparation Failure to prepare Fresh Frozen Plasma [from blood collected by a single uninterrupted venipuncture]  [separated from the red blood cells, placed in a freezer within the appropriate time frame, and stored at - 18 degrees Celsius or colder].  Specifically, ***
272 21 CFR 640.34(b) 1 Fresh Frozen Plasma - storage requirements Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma, in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder.  Specifically, ***
325 21 CFR 640.63(c)(10) 1 Narcotics use Each donor was not in good health on the day of donation, as indicated in part by [arms] [forearms] with [skin punctures] [scars] indicative of addiction to self-injected narcotics.  Specifically, ***
335 21 CFR 640.65(b)(1)(i) 1 Serological test Failure to draw from each donor [on the day of the first medical exam or plasmapheresis] [at least every 4 months] a sample of blood tested for [syphilis] [total plasma or serum protein determination] [serum protein electrophoresis or equivalent test].  Specifically, ***
343 21 CFR 640.65(b)(3) 1 Donor identification system Failure to establish a donor identification system that positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.  Specifically, ***
369 21 CFR 640.72(a)(1) 1 Shipping temperature requirements Failure to maintain documentation establishing that the shipping temperature requirements are being met for Source Plasma intended for manufacture into injectable products.  Specifically, ***
3252 21 CFR 640.63(a) 1 Determination not made on day of collection Determination of the suitability of Source Plasma donors was not made on the day of collection.  Specifically, ***
3258 21 CFR 640.63(d) 1 Unreliable answers Failure to consider as unsuitable any donor who does not appear to be providing reliable answers to medical history questions.  Specifically, ***
3618 21 CFR 606.100(b)(19) 1 Procedure for HIV lookback There is no written procedure to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to human immunodeficiency virus, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations.  Specifically, ***
9005 21 CFR 606.100(b)(19) 1 Notification of consignees re: antibody test results The written procedures for HIV "lookback" fail to include notification of consignees for Whole Blood, blood components, Source Plasma, and Source Leukocytes of the results of antibody testing of a donor of blood who has tested repeatedly reactive for antibody to human immunodeficiency virus, or otherwise has been determined to be unsuitable when tested in accordance with the applicable regulations.  Specifically, ***
9051 21 CFR 600.11(a) 1 Work areas - temperatures The [refrigerators] [incubators] [temperature controlled rooms] [are not maintained at the required temperatures] [are not free of extraneous material that may affect the safety of the product].  Specifically, ***
9076 21 CFR 600.12(a) 1 Maintenance  - concurrence Records are not made [concurrently with the performance] of each step in the [manufacture] [distribution] of products.  Specifically, ***
9077 21 CFR 600.12(a) 1 Maintenance - completeness The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product].  Specifically, ***
9080 21 CFR 600.12(b)(2) 1 Retention - Records of Recall Recall records for distributed product [were] [are] not [generated] [retained] [complete].  Specifically, ***
9092 21 CFR 600.80(b) 1 Review of Adverse Experiences - follow up information Failure to submit all follow up information on adverse experience reports to FDA, as required.  Specifically, ***
9107 21 CFR 600.11(h) 1 Sterile & pyrogen free There is no assurance that [final containers] [closures] for products intended for use by injection are [sterile] [pyrogen free].  Specifically, ***
9223 21 CFR 606.160(b)(6) 1 Required records - transfusion reaction and complaints Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up.  Specifically, ***
9237 21 CFR 630.6(b)(2) 1 Type of donations Failure to notify the donor of the types of donations of blood or blood components that the donor should not donate in the future.  Specifically, ***
9240 21 CFR 630.6(d)(1) 1 Physician notification Failure to provide to an autologous donor's referring physician [information that the autologous donor is deferred based on the results of tests for evidence of infection due to communicable disease agents, and the reason for that decision] [the types of donation of blood and blood components that the autologous donor should not donate in the future] [the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral] [results of any supplemental tests].  Specifically, ***
9242 21 CFR 630.6(d)(2) 1 Notification Failure to [make] [document] reasonable attempts to notify the autologous donor's referring physician within 8 weeks after determining that the autologous donor is deferred.  Specifically, ***
9256 21 CFR 610.41 1 Donor Deferral Failure to defer a donor who tested reactive [by a screening test for evidence of infection due to a communicable disease agent] [for a serological test for syphilis] from further donations of human blood and blood components.  Specifically, ***
10009 n/a 1 Conditions of probation Deviation from conditions of probation.  Specifically, ***

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Parts 1240 and 1250

Center Name Cite Id Ref No Frequency Short Description Long Description
Parts 1240 and 1250 7036 21 CFR 1250.67 76 Prevention of contamination Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps] [faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking] [culinary] water.  Specifically, ***
6560 21 CFR 1250.32(a) 38 Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils].  Specifically, ***
7032 21 CFR 1250.63 36 Prevention of the spread of communicable diseases Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable diseases.  Specifically, *** 
6552 21 CFR 1250.28 22 Handling to avoid contamination Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination.  Specifically, ***
6558 21 CFR 1250.30(d) 18 Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils].  Specifically, ***
6570 21 CFR 1250.33(c) 14 Storage and handling after bactericidal treatment Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.  Specifically, ***
6569 21 CFR 1250.33(b) 11 Equipment kept clean Failure to keep all equipment clean.  Specifically, ***
6564 21 CFR 1250.33(a) 10 Maintained in good repair Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair.  Specifically, ***
7053 21 CFR 1250.75(b) 10 Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].  Specifically, ***
6555 21 CFR 1250.30(a) 9 Clean and free from flies, rodents, and other vermin Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin].  Specifically, ***
6572 21 CFR 1250.34 9 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof.  Specifically, ***
6581 21 CFR 1250.38(b) 9 Soap, sanitary towels, water Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water].  Specifically, ***
6591 21 CFR 1250.42(a) 8 Backflow protection A water system not protected against backflow.  Specifically, ***
6593 21 CFR 1250.42(b) 6 Connections easily cleanable, located and protected Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply.  Specifically, ***
7055 21 CFR 1250.75(b) 6 Equipment for cleaning and flushing Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and waste carts] is [not designed so as to prevent backflow into the water line] [used for a purpose connected with the handling of food, water, or ice].  Specifically, ***
7090 21 CFR 1250.82(e) 6 Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment].  Specifically, ***
6567 21 CFR 1250.33(b) 5 Cleaning of multiuse eating and drinking utensils Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse eating and drinking utensils after each use.  Specifically, ***
6580 21 CFR 1250.38(b) 5 Signs Signs directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such employees].  Specifically, ***
7051 21 CFR 1250.75(a) 5 Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations].  Specifically, ***
6549 21 CFR 1250.27 4 Storage of perishables Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving.  Specifically, ***
6584 21 CFR 1250.39 3 Containers - watertight, readily cleanable, non-absorbent Garbage containers are not [watertight] [readily cleanable] [non-absorbent].  Specifically, ***
6585 21 CFR 1250.39 3 Containers - close-fitting covers Garbage containers lack close-fitting covers.  Specifically, ***
7041 21 CFR 1250.70(a) 3 Adequate and readily accessible Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained] [cleaned].  Specifically, ***
6561 21 CFR 1250.32(b) 2 Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment].  Specifically, ***
6565 21 CFR 1250.33(a) 2 Adequate facilities for cleaning, bactericidal treatment Adequate facilities are not provided for the [cleaning] [bactericidal treatment] of [multiuse eating and drinking utensils] [equipment used in the preparation of food and beverages].  Specifically, ***
6579 21 CFR 1250.38(a) 2 Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees.  Specifically, ***
6609 21 CFR 1250.49 2 Clean and free of flies and mosquitoes Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit.  Specifically, ***
7038 21 CFR 1250.67 2 Signs for non-potable water Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking.  Specifically, ***
7042 21 CFR 1250.70(a) 2 Clean and sanitary Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition.  Specifically, ***
7089 21 CFR 1250.82(d) 2 Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification.  Specifically, ***
6531 21 CFR 1250.22 1 Clean, wholesome, free from spoilage Not all [food] [drink] served onboard is [clean] [wholesome] [free from spoilage].  Specifically, ***
6554 21 CFR 1250.30(a) 1 Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated].  Specifically, ***
6563 21 CFR 1250.33(a) 1 Easily cleaned, self-draining Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are constructed so as to be [easily cleaned] [self-draining].  Specifically, ***
6568 21 CFR 1250.33(b) 1 Cleaning of all other utensils Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the day's operation.  Specifically, ***
6582 21 CFR 1250.38(c) 1 Maintained in clean condition Failure to maintain toilet rooms in a clean condition.  Specifically, ***
6588 21 CFR 1250.41 1 Submittal of construction plans Failure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review.  Specifically, ***
6612 21 CFR 1250.50 1 Designed to permit ready cleaning Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning.  Specifically, ***
7054 21 CFR 1250.75(b) 1 Soil cans and removable containers Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use.  Specifically, ***
7056 21 CFR 1250.75(c) 1 Persons handling soil cans and other containers Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected with the [loading] [unloading] [transporting] [handling] of [food] [water] [ice].  Specifically, ***
7092 21 CFR 1250.82(f) 1 Cleaning, disinfecting, flushing Failure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.  Specifically, ***
7111 21 CFR 1250.87 1 Cross connections Systems for wash water do not meet the requirements of a potable water system, and the distribution system is cross-connected to a system carrying water of lower sanitary quality.  Specifically, ***

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Human tissue for transplantation

Center Name Cite Id Ref No Frequency Short Description Long Description
Human tissue for transplantation 12221 21 CFR 1271.47(a) 34 Procedures for all steps Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12336 21 CFR 1271.180(a) 26 Procedures to meet core CTGP Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12416 21 CFR 1271.260(e) 15 Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, ***
12230 21 CFR 1271.50(a) 11 Responsible person to determine, document The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on results of donor screening and donor testing.  Specifically, ***
12310 21 CFR 1271.160(a) 11 All core requirements covered in program A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12213 21 CFR 1271.47(a) 10 Donor eligibility procedures Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12247 21 CFR 1271.55(d)(2) 10 Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, ***
12277 21 CFR 1271.75(a)(1) 9 Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for [risk factors]  [clinical evidence] of communicable disease agents and diseases.  Specifically, ***
12326 21 CFR 1271.160(c) 9 Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed.  Specifically, ***
12431 21 CFR 1271.265(e) 9 Procedures and release criteria Procedures including  release criteria for activities relating to  the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12229 21 CFR 1271.50(a) 8 Determination based on screening and testing HCT/P donors were not determined to be eligible based on the results of donor screening and testing.  Specifically, ***
12309 21 CFR 1271.160(a) 8 Program is appropriate for the HCT/Ps A quality program appropriate for the  HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12334 21 CFR 1271.170(c) 8 Trained or re-trained as necessary Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities.  Specifically, ***
12457 21 CFR 1271.320(a) 8 Procedures re complaints Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12223 21 CFR 1271.47(b) 7 Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
12286 21 CFR 1271.80(b) 7 Specimen collections not  timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, ***
12237 21 CFR 1271.55(a)(3) 6 Summary--records used to make determination After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination.  Specifically, ***
12301 21 CFR 1271.150(c)(1)(iii) 6 Ensurane of compliance You did not ensure that establishment(s) that  by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the initiation of the contract, agreement of arrangement] [applicable CGTP requirements after information became available that suggested the establishment was no longer in compliance].  Specifically, ***
12369 21 CFR 1271.200(b) 6 Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, ***
12417 21 CFR 1271.260(e) 6 Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.  Specifically, ***
12433 21 CFR 1271.265(f) 6 Return to inventory--procedures Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned to inventory were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12239 21 CFR 1271.55(b)(2) 5 Listing and interpretation of CD tests performed The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed.  Specifically, ***
12283 21 CFR 1271.75(e) 5 Abbreviated procedure  The abbreviated donor screening procedure [was used for donors who had no complete donor screening procedure in the previous six months] [did not determine and document changes in the donor's medical history that would make the donor ineligible].  Specifically, ***
12332 21 CFR 1271.170(b) 5 Qualifications lacking Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.  Specifically, ***
12414 21 CFR 1271.260(d) 5 Corrective actions Corrective actions were not [performed] [documented] when proper storage conditions were not met.  Specifically, ***
12429 21 CFR 1271.265(d) 5 Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.  Specifically, ***
12444 21 CFR 1271.270(e) 5 Contract firms--identities and responsibilities The [name and address] [list of responsibilities] of establishment(s) that perform manufacturing steps for you [was not maintained] [was not made available to FDA during an inspection].  Specifically, ***
12492 21 CFR 1271.85(a) 5 Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents.  Specifically, ***
12493 21 CFR 1271.90(b) 5 Eligibility not required--warning labels HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements.  Specifically, ***
15020 21 CFR 1271.200(e) 5 Documentation of maintenance and cleaning Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.  Specifically, ***
12225 21 CFR 1271.47(d) 4 Departures: recording and justifying Departures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded] [justified].  Specifically, ***
12231 21 CFR 1271.50(b)(1) 4 Donor screening standards Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk factors for infection due to communicable disease agents] [clinical evidence of infection due to communicable disease agents] [risk factors associated with xenotransplantation].  Specifically, ***
12311 21 CFR 1271.160(b)(1) 4 Ensuring appropriate core requirements followed The quality program has not ensured that appropriate procedures related to core CGTP requirements were  [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [approved] [revised].  Specifically, ***
12312 21 CFR 1271.160(b)(2) 4 Procedures for complaints and other information The quality program has not ensured that procedures exist for [receiving] [investigating] [evaluating] [documenting] information relating to core CGTP requirements, including complaints.
12338 21 CFR 1271.180(b) 4 Review and approval-responsible person Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
12421 21 CFR 1271.265(a) 4 Acceptance criteria designed to prevent CD  Incoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria designed to prevent communicable disease transmission.  Specifically, ***
12435 21 CFR 1271.270(a) 4 Records maintained concurrently Records were not maintained concurrently with the performance of each step.  Specifically, ***
12453 21 CFR 1271.290(e) 4 Documenting disposition of each HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if any].  Specifically, ***
12496 21 CFR 1271.85(b)(2) 4 SOP for release; reactive for CMV A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically. ***
12238 21 CFR 1271.55(b)(1) 3 Statement re: certified testing lab The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.  Specifically, ***
12242 21 CFR 1271.55(c) 3 Name and personal info on accompanying records The accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor].  Specifically, ***
12246 21 CFR 1271.55(d)(1)(iii) 3 Documentation--determination, by whom, date Documentation of [the donor-eligibility determination] [the responsible person who made the donor-eligibility determination] [the date of the donor-eligibility determination] was not maintained.  Specifically, ***
12314 21 CFR 217.160(b)(2)(iii) 3 Risk assessment, quarantine, recall, FDA The quality program has not ensured that procedures include provisions for [assessing the risk of] [quarantine of] [recall of] [reporting to FDA on] HCT/Ps that have been made available for distribution and for which there is information related to the possible contamination or communicable disease transmission.  Specifically, ***
12322 21 CFR 1271.160(b)(4) 3 Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, ***
12323 21 CFR 1271.160(b)(5) 3 Monitoring systems The quality program has not established and maintained appropriate monitoring systems.  Specifically, ***
12324 21 CFR 1271.160(b)(6) 3 Deviations--Investigation, documenting, trending The quality program does not include [the investigation] [the documentation] [the trending] [the reporting] of HCT/P deviations relating to core CTGP requirements.  Specifically, ***
12325 21 CFR 1271.160(b)(6) 3 Deviations--evaluation, cause, corrective action Investigation of deviations related to core  CGTP requirements did not include [a review and evaluation of the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the deviation and prevent recurrence].  Specifically, *** 
12339 21 CFR 1271.180(c) 3 Availability of procedures Procedures for core CTGP requirements were not available to personnel  in the area where operations are performed, or in a nearby area when such availability is impractical.  Specifically, ***
12365 21 CFR 1271.195(d) 3 Documentation not maintained Documentation of environmental control and monitoring activities was not maintained.  Specifically, ***
12372 21 CFR 1271.200(c) 3 Calibrated per established schedules Equipment used for [inspection] [measuring] [testing] was not calibrated  according to established schedules.  Specifically, ***
12375 21 CFR 1271.210(a) 3 Use prior to verification  Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease.  Specifically, ***
12395 21 CFR 1271.225 3 Verification/validation Process changes were not [validated] [verified]  to ensure the change does not cause an adverse impact elsewhere in operations.  Specifically, ***
12398 21 CFR 1271.230(a) 3 Validation & approval--established procedures Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures.  Specifically, ***
12399 21 CFR 1271.230(a) 3 Process validation procedures Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12411 21 CFR 1271.260(a) 3 Contamination, mix ups, improper release Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made available for distribution].  Specifically, ***
12437 21 CFR 1271.270(a) 3 Records incomplete Records [did not identify the person performing the work] [did not show the dates of entries] [were not detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P involved].  Specifically, ***
3744 21 CFR 1270.33(a) 2 Accurate, indelible, legible Failure to maintain records which are [accurate] [indelible] [legible].  Specifically, ***
12222 21 CFR 1271.47(a) 2 Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.  Specifically, ***
12236 21 CFR 1271.55(a)(2) 2 Eligibility statement--basis of determination After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.  Specifically, ***
12240 21 CFR 1271.55(b)(3) 2 Name and address on summary The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination.  Specifically, ***
12252 21 CFR 1271.60(a) 2 Completion of eligibility determination HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.  Specifically, ***
12272 21 CFR 1271.65(b)(2) 2 Labeled re: biohazard, risks, test results HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning of the reactive test results].  Specifically, ***
12279 21 CFR 1271.75(b) 2 Risk factors, leukocyte-rich cells or tissues Donors of leukocyte-rich cells or tissues were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of cell-associated communicable disease agents and diseases. Specifically, ***
12282 21 CFR 1271.75(d) 2 Donors with risks not determined ineligible Donors were not determined to be ineligible that had [risk factors or clinical evidence of communicable disease agents] [communicable disease risks associated with xenotransplantation].  Specifically, ***
12287 21 CFR 1271.80(c) 2 Kits not FDA approved, specifically labeled Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests] [were not specifically labeled for cadaveric specimens when such a test was available and cadaveric specimens were used].  Specifically, ***
12288 21 CFR 1271.80(c) 2 Manufacturer instructions not followed Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.  Specifically, ***
12290 21 CFR 1271.80(d)(1) 2 Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.  Specifically, ***
12319 21 CFR 1271.160(b)(3) 2 Actions taken and documented The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented].  Specifically, ***
12328 21 CFR 1271.160(d) 2 Validation for intended use The performance of [custom computer software] [commercial computer software that has been customized or programmed], including changes to computer software, has not been validated for the intended use, when such software is relied upon to comply with core GTP requirements.  Specifically, ***
12337 21 CFR 1271.180(a) 2 Design adequate to bar spread of CD's Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and spread through the use of HCT/Ps.  Specifically, ***
12359 21 CFR 1271.195(a)(3) 2 Aseptic processing---cleaning, disinfecting Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing.  Specifically, ***
12364 21 CFR 1271.195(c) 2 Monitoring-microorganisms where appropriate Environmental conditions were not monitored for microorganisms.  Specifically, ***
12368 21 CFR 1271.200(a) 2 Capable of valid results Equipment used for [inspection] [measuring] [testing] was not capable of producing valid results.  Specifically, ***
12370 21 CFR 1271,200(c) 2 Calibration procedures and schedules (general) The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing] were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12412 21 CFR 1271.260(b) 2 Storage temperatures appropriate HCT/Ps were not stored at appropriate temperatures.  Specifically, ***
12432 21 CFR 1271.265(e) 2 Documentation elements for activities Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include [identification of the HCT/P and the establishment that supplied the HCT/P] [activities performed and the results of each activity] [date(s) of activity] [quantity of HCT/P subject to the activity] [disposition of the HCT/P (identity of consignee)].  Specifically, ***
12436 21 CFR 1271.270(a) 2 Accurate, indelible, legible Records were not [accurate] [indelible] [legible].  Specifically, ***
12447 21 CFR 1271.290(b) 2 Establishing a system A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ****
12460 21 CFR 1271.320(c) 2 Review and evaluation, report to FDA  Complaints were not reviewed and evaluated to determine [if the complaint is related to an HCT/P deviation or adverse reaction] [whether a report to FDA is required].  Specifically, ***
12472 21 CFR 1271.350(b)(1) 2 Deviations not investigated HCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated.  Specifically, ***
12473 21 CFR 1271.350(b)(2) 2 Deviations not reported to FDA HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an establishment under contract, agreement, or arrangement with your establishment] were not reported to FDA.  Specifically, ***
15024 21 CFR 1271.320(b) 2 Available for review and copying by FDA The complaint file was not made available for review and copying upon request from FDA.  Specifically, ***
3745 21 CFR 1270.33(a) 1 Person involved, dates, details Records fail to [identify the person performing the work] [include the dates of the various entries] [be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved].  Specifically, ***
3758 21 CFR 1270.35(c) 1 Receipt and/or distribution Records fail to include documentation of receipt and/or distribution of human tissue.  Specifically, ***
12232 21 CFR 1271.50(b)(2) 1 Donor testing not negative for CD agents Donor testing of HCT/P donors considered eligible was not negative  or nonreactive for relevant communicable disease agents.  Specifically, ***
12234 21 CFR 1271.55(a)(1) 1 Identification code affixed to container After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a distinct identification code affixed to the HCT/P container.  Specifically, ***
12235 21 CFR 1271.55(a)(1) 1 Personal information included in I.D. code The distinct identification code affixed to the HCT/P container included an individual's [name] [social security number] [medical record number].  Specifically, ***
12243 21 CFR 1271.55(d)(1) 1 Documentation maintained (general) Documentation was not maintained after the donor-eligibility determination was complete.  Specifically, ***
12257 21 CFR 1271.60(c)(2) 1 Records stating determination not completed HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the donor-eligibility determination had not been completed.  Specifically, ***
12258 21 CFR 1271.60(c)(3) 1 Statement of restrictions HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the product must not be implanted, transplanted, infused or transferred until completion of the donor-eligibility determination.  Specifically, ***
12270 21 CFR 1271.65(a) 1 Improper release prevention--storage, I.D. HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release.  Specifically, ***
12291 21 CFR 1271.80(d)(2) 1 Plasma diluted test specimens Donors were not determined to be ineligible whose communicable disease test specimens were plasma diluted, and [the donor was not tested using a specimen which was taken before transfusion or infusion and within seven days before recovery of the cells or tissue] [an appropriate algorithm was not used to determine that the plasma dilution did not affect the test results].  Specifically, ***
12315 21 CFR 1271.160(b)(2) 1 Sharing of information (general) The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or communicable disease transmission of HCT/Ps.  Specifically, ***
12320 21 CFR 1271.160(b)(3) 1 Actions verified, short and long term solutions Corrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and compliance with CGTP] [did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence].  Specifically, ***
12333 21 CFR 1271.170(b) 1 Not qualified, authorized for functions Personnel perform functions for which they are not [qualified] [authorized].  Specifically, ***
12340 21 CFR 1271.180(d) 1 Adopted from another organization Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations].  Specifically, ***
12343 21 CFR 1271.190(a) 1 State of repair Facilities were not maintained in a good state of repair.  Specifically, ***
12344 21 CFR 1271.190(a) 1 Lighting, ventilation, plumbing Facilities did not provide adequate [lighting] [ventilation] [plumbing] [drainage] [access to sinks and toilets] to prevent the introduction, transmission or spread of communicable disease.  Specifically, ***
12351 21 CFR 1271.190(d)(1) 1 Procedures for cleaning, sanitation Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, ***
12356 21 CFR 1271.195(a) 1 Adequate control, proper conditions Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for operations were not provided].  Specifically, ***
12362 21 CFR 1271.195(b) 1 Corrective actions Appropriate corrective actions were not taken related to the inspections of environmental control systems.  Specifically, ***
12371 21 CFR 1271.200(a) 1 Cleaned, sanitized per established schedules Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]  according to established schedules.  Specifically, ***
12373 21 CFR 1271.200(d) 1 Inspected routinely Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules].  Specifically, ***
12382 21 CFR 1271.210(d)(3) 1 Lot documentation maintained Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained.  Specifically, ***
12387 21 CFR 1271.220(a) 1 Causing contamination, increasing risks HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during processing] [that does not increase the risk of introduction, transmission, or spread of communicable disease].  Specifically, ***
12396 21 CFR 1271.225 1 Approval and timely communication Process changes were [not approved by a responsible person with appropriate knowledge and background prior to implementation] [not communicated to personnel in a timely manner].  Specifically, ***
12405 21 CFR 1271.250(a) 1 Controlling the labeling of HCT/Ps Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12408 21 CFR 1271.250(c) 1 All labeling requirements met Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements.  Specifically, ***
12409 21 CFR 1271.250(c) 1 Documentation of donor eligibility Labeling procedures did not ensure that HCT/Ps made available for distribution are accompanied by documentation of the donor eligibility determination.  Specifically, ***
12415 21 CFR 1271.260(e) 1 Temperature limits Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents.  Specifically, ***
12423 21 CFR 1271.265(b) 1 Shipment in quarantine of HCT/Ps HCT/Ps shipped as pre-distribution shipments [within your establishment] [between establishments] which do not meet the criteria for being available for distribution were not shipped in quarantine.  Specifically, ***
12424 21 CFR 1271.265(c)(1) 1 Release criteria verified, documented  Release criteria were not [verified] [documented] to have been met through a review of manufacturing and tracking records before HCT/Ps were made available for distribution.  Specifically, ***
12427 21 CFR 1271.265(c)(3) 1 HCT/Ps made under departure from process A responsible person did not determine that HCT/Ps manufactured under a departure from procedures do not increase the risk of communicable disease prior to making the HCT/Ps available for distribution.  Specifically, ***
12428 21 CFR 1271.265(c)(3) 1 Departures:  recorded and justified Departures from procedures were not [recorded] [justified] at the time of occurrence.  Specifically, ***
12440 21 CFR 1271.270(b) 1 Prompt retrieval from multiple locations The records management system was not designed to ensure that records stored in more than one location can be promptly identified and retrieved.  Specifically, ***
12443 21 CFR 1271.270(d) 1 Retention time (10 year rules) Records were not retained for the appropriate length of time,  [10 years after their creation] [at least 10 years after the date of administration of a particular HCT/P] [at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of administration is not known] [10 years after the appropriate disposition of archived specimens of dura mater].  Specifically, ***
12458 21 CFR 1271.320(b) 1 Designated complaint file Complaints received were not maintained in a file designated for complaints.  Specifically, ***
12470 21 CFR 1271.350(a)(2) 1 15 day reporting timeframe Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information.  Specifically, ***
12475 21 CFR 1271.370(a) 1 Clear and accurate label HCT/Ps made available for distribution were not labeled [clearly] [accurately].  Specifically, ***
12476 21 CFR 1271.370(b)(1) 1 Identification code affixed HCT/Ps made available for distribution were not labeled with a distinct identification code affixed to the HCT/P container.  Specifically, ***
12490 21 CFR 1271.85(b)(1) 1 Cell-associated CD  Donors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases.  Specifically, ***
15019 21 CFR 1271.160(d) 1 Computer software verification The performance of computer software has not been verified.  Specifically, ***
15022 21 CFR 1271.200(e) 1 Documentation of use Records of the use of each piece of equipment, and the HCT/Ps manufactured with the equipment, were not maintained.  Specifically, ***

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Radiological health

Center Name Cite Id Ref No Frequency Short Description Long Description
Radiological health 5007 21 CFR 1002.13 7 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one.  Specifically, ***
5034 21 CFR 1010.2(c) 7 Certification not based on adequate test/testing program Certification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices].  Specifically, ***
5700 21 CFR 1002.10 4 Failure to submit, distinct marking You did not submit a required product report [distinctly marked "Radiation Safety Product Report of (your name)"] prior to the introduction of the product into commerce.  Specifically, ***
5194 21 CFR 1040.10(g)(9) 3 Label locations All labels affixed to a laser product were not affixed so as to make unnecessary during reading, human exposure to laser radiation in excess of the accessible emission limits of Class I radiation or the limits of collateral radiation established in table VI of 21 CFR 1040.10(d). Specifically, ***
5005 21 CFR 1002.11 2 Failure to submit You did not submit a required supplemental report, prior to the introduction of the product into commerce, for a new or modified model within a model or chassis family.  Specifically, ***
5044 21 CFR 1010.3(a)(2) 2 ID label lacks place, month & year of manufacture An identification label fails to provide the [place] [month] [year] of manufacture.  Specifically, ***
5144 21 CFR 1040.10(f)(2)(i) 2 Safety interlock not provided Each laser product was not provided with at least one safety interlock for each portion of the protective housing which is designed to be removed or displaced during operation or maintenance, when such removal or displacement permitted human access to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI.  Specifically, ***
5443 21 CFR 1020.30(g) 2 Providing adequate assembly information Instructions for [assembly] [installation] [adjustment] [testing] of components adequate to assure that the product will comply with the regulations, when [assembled] [installed] [adjusted]  [tested] as directed, was not provided to [assemblers] [persons other than assemblers, upon request, at a cost not to exceed the cost of publication and distribution]  Specifically, ***
5006 21 CFR 1002.12 1 Not submitted prior to introduction You did not submit an abbreviated report, required by 21 CFR 1002.1, prior to introduction of the product.  Specifically, ***
5032 21 CFR 1010.2(b) 1 Certification label or tag A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible] [readily accessible to view when the product is fully assembled for use].  Specifically, ***
5043 21 CFR 1010.3(a)(1) 1 ID label lacks name and address An identification label failed to provide the name and address of the [manufacturer] [individual or company under whose name the product was sold].  Specifically, ***
5048 21 CFR 1010.4(d) 1 Variances - Improper certification Failure to modify the [tag] [label] [certification] of a product for which a variance has been granted to state [that the product conforms to the applicable standard, except with respect to those characteristics covered by the variance] [that the product conforms with the provisions of the variance] [the assigned number and effective date of the variance].  Specifically ***
5122 21 CFR 1030.10(c)(3)(iii) 1 Measurements with tap water container Microwave oven measurements were not made with the microwave oven [operating at maximum output] [containing a load of  275 ± 15 milliliters of  tap water initially at 20 ± 5 degrees centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer].  Specifically, ***
5141 21 CFR 1040.10(e)(1) 1 Certification tests inadequate The tests on which certification is based failed to account for [all errors and statistical uncertainties in the measurement process]  [increases in emission and degradation in radiation safety with age].  Specifically, ***
5147 21 CFR 1040.10(f)(2)(iii)(b) 1 No multiple safety interlocks for Class II emission limits   A laser product was not provided with either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing, when failure of a single interlock allowed laser radiation in excess of the accessible emission limits of Class II to be emitted directly through the opening created in the protective housing.  Specifically, ***
5150 21 CFR 1040.10(f)(3) 1 Remote interlock connector Each laser system classified as a Class IIIb or Class IV laser product [was not incorporated with a readily available remote interlock connector having an electrical potential difference of no greater than 130 root-mean-square volts between terminals.] [had no means to prevent, when the terminals of the connector are not electrically joined, human access to all laser and collateral radiation from the laser product in excess of the accessible emission limits of Class I and table VI.]  Specifically, ***
5152 21 CFR 1040.10(f)(5)(i) 1 Emission indicator - Class II & IIIa An emission indicator was not incorporated in each laser system classified as a Class II or Class IIIa laser product that provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I.  Specifically, ***
5155 21 CFR 1040.10(f)(5)(iii) 1 Emission indicator pre 8/20/86 Both laser and laser energy source fail to incorporate an emission indicator, when the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters (laser systems manufactured on or before August 20, 1986). Specifically, ***
5171 21 CFR 1040.10(g)(3) 1 Class IV "Danger" label Each Class IV laser product does not have affixed a label  [bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation].  Specifically, ***
5173 21 CFR 1040.10(g)(5)(i) 1 Aperture label - laser radiation The warning statement "AVOID EXPOSURE---Laser radiation is emitted from this aperture" was not affixed in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the accessible emission limits of Class I and table VI of Section 1040.10(d).  Specifically, ***
5185 21 CFR 1040.10(g)(7)(i) 1 DIPH label wording - Class II Labels regarding Class II accessible laser radiation which [are visible on the product prior to and during interlock defeat]  [are in close proximity to the opening created by the removal or displacement of such portion of the protective housing] [include the wording: "CAUTION --- Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM."] were not provided for defeatably interlocked protective housings. Specifically, ***
5195 21 CFR 1040.10(g)(10) 1 Labels legible, visible, permanent Labels which are legible and clearly visible during operation, maintenance, or service are not permanently affixed to or inscribed on laser products.  Specifically, ***
5200 21 CFR 1040.10(h)(1)(iv) 1 User info - list controls, etc. The manufacturer did not provide or cause to be provided  a listing of [all controls] [all adjustments] [all procedures for operation and maintenance] [the warning: "Caution --- use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure."]. Specifically, ***
5203 21 CFR 1040.10(h)(2)(i) 1 Reproduction of affixed information The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets] [descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation] [the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to be affixed to the product. Specifically, ***
5213 21 CFR 1040.11(c) 1 Demonstration laser products  Each demonstration laser product  [does not comply with all of the applicable requirements for a Class I, IIa, II, or IIIa  laser product] [prevent human access to laser radiation in excess of the accessible emission limits of Class I, IIa, II or IIIa].  Specifically, *** 
5479 21 CFR 1020.30(n) 1 Compliance measurement Compliance with the aluminum equivalence limits was not determined by x-ray measurements made [at a potential of 100 kilovolts peak] [with an x-ray beam that has a half-value layer of 2.7 millimeters of aluminum].  Specifically, ***
5690 21 CFR 1002.10(g) 1 Methods and procedures in testing radiation safety A product report did not describe the methods and procedures employed in testing and measuring each model with respect to electronic product radiation safety, including [the control of unnecessary, secondary, or leakage electronic product radiation] [the applicable quality control procedures used for each model] [the basis for selecting testing and quality control procedures].  Specifically, *** 
5705 21 CFR 1002.31(a) 1 Five year requirement You have not preserved your required record(s) for a period of five years from the date of the record.  Specifically, ***
5769 21 CFR 1020.33(c)(2)(i)(a) 1 CTDI along the axis of rotation of the phantom The computed tomography dose index (CTDI) is not provided to users for locations along the axis of rotation of the dosimetry phantom.   Specifically, ***
5784 21 CFR 1010.2(b) 1 Certification other than by tag or label Certification of a product is not in conformance with [the manner prescribed in an applicable standard] [the alternate means approved by FDA].  Specifically, ***
5802 21 CFR 1002.13 1 Lack of required elements An annual report which you submitted did not [summarize the contents of the records required by 21 CFR 1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period ending on June 30 preceding the due date of the report]. Specifically, ***
5811 21 CFR 1002.30(a)(1) 1 Quality control procedures You have not [established] [maintained] records containing a description of quality control procedures with respect to electronic product radiation safety.  Specifically, ***

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