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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FY 2013 Inspectional Observation Summaries

 

Number of 483s issued from the System* 

Inspections ending between 10/1/2012 12:00:00 AM and 9/30/2013 12:00:00 AM

Center Name 483s issued
Foods 2386
Devices 1099
Drugs 690
Veterinary medicine 328
Bioresearch monitoring 273
Biologics 191
Human tissue for transplantation 121
Parts 1240 and 1250 91
Radiological health 32
Sum Product Area 483s from System* 5211
Actual Total in system 483s** 5050

*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.

Back to Inspectional Observation Summaries


 

Foods

Center Name Cite Id Ref No Frequency Short Description Long Description
Foods 1560 21 CFR 110.35(c) 318 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) 300 Sanitation monitoring You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including [safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests].  Specifically, ***
1306 21 CFR 110.20(b)(7) 224 Screening Failure to provide adequate screening or other protection against pests.  Specifically, ***
905 21 CFR 123.6(b) 177 HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, ***
959 21 CFR 123.6(c)(1) 171 Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.  Specifically, ***
1422 21 CFR 110.20(b)(4) 160 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, ***
960 21 CFR 123.6(c)(2) 159 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, ***
904 21 CFR 123.6(b) 157 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, ***
1552 21 CFR 110.35(a) 152 Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, ***
1525 21 CFR 123.11(c) 144 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, ***
961 21 CFR 123.6(c)(3) 140 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) 140 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***
1581 21 CFR 110.37(e) 132 Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature.  Specifically, ***
1695 21 CFR 110.80(b)(2) 132 Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].  Specifically, ***
6004 21 CFR 123.6(c)(4) 131 Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit.  Specifically***
1287 21 CFR 110.20(a)(1) 127 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, ***
1554 21 CFR 110.35(a) 125 Cleaning and sanitizing operations Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
1701 21 CFR 110.80(b)(7) 125 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, ***
1689 21 CFR 110.80 124 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, ***
1553 21 CFR 110.35(a) 122 Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated.  Specifically, ***
1597 21 CFR 110.37(b)(3) 115 As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  Specifically, ***
1427 21 CFR 110.20(b)(5) 109 Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food.  Specifically, ***
2386 21 CFR 110.80(a)(1) 107 Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, ***
990 21 CFR 110.10(b)(3) 104 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, ***
908 21 CFR 123.6(d) 92 Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually].  Specifically, ***
1405 21 CFR 110.10(b)(6) 90 Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.  Specifically, ***
1562 21 CFR 110.35(d) 86 Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food.  Specifically, ***
1125 21 CFR 110.40(a) 84 Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, ***
6008 21 CFR 123.8(a)(3) 84 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, ***
6020 21 CFR 123.9(a) 83 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, ***
945 21 CFR 123.12(a)(2) 76 Importer verification You do not have or have not implemented [written verification procedures] [product specifications] [an affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with the Seafood HACCP regulation.  Specifically, ***
1556 21 CFR 110.35(b)(2) 76 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, ***
15858 21 CFR 111.75(a)(1)(i) 75 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, ***
2392 21 CFR 110.80(b)(1) 74 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, ***
1424 21 CFR 110.20(b)(4) 73 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, ***
1066 21 CFR 110.40(b) 72 Seams on food contact surfaces Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of microorganisms.  Specifically, ***
6005 21 CFR 123.6(c)(6) 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, ***
15797 21 CFR 111.553 70 Written procedures - product complaint You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint.  Specifically, ***
15869 21 CFR 111.75(c) 70 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, ***
1615 21 CFR 110.93 68 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination.  Specifically, ***
6021 21 CFR 123.10 68 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.  Specifically, ***
1007 21 CFR 110.10(b)(9) 67 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, ***
15839 21 CFR 111.70(e) 67 Specifications - identity, purity, strength, composition You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement.  Specifically, ***
3652 21 CFR 110.37(e)(1) 66 Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.  Specifically, ***
15861 21 CFR 111.75(a)(2)(ii)(A) 66 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, ***
1292 21 CFR 110.20(b)(1) 64 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, ***
15762 21 CFR 111.205(a) 63 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, ***
933 21 CFR 123.8(a)(2)(ii) 62 Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, ***
3661 21 CFR 110.37(e)(5) 62 Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, ***
15659 21 CFR 111.475(b)(1) 60 Written procedures - holding; distributing You did not make and keep written procedures for holding and distributing operations.  Specifically, ***
15927 21 CFR 111.103 59 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations.  Specifically, ***
901 21 CFR 123.6(a) 57 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, ***
15532 21 CFR 111.255(b) 55 Batch record - complete Your batch production record did not include complete information relating to the production and control of each batch.  Specifically, ***
985 21 CFR 110.10(b)(1) 54 Suitable outer garments Suitable outer garments are not worn  that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, ***
1599 21 CFR 110.37(b)(5) 54 Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, ***
6018 21 CFR 123.7(a) 53 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,***
1006 21 CFR 110.10(b)(8) 51 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, ***
1173 21 CFR 110.40(f) 51 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,***
1698 21 CFR 110.80(b)(5) 51 Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, ***
3658 21 CFR 110.37(e)(2) 51 Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, ***
1702 21 CFR 110.80(b)(8) 49 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) 49 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, ***
6001 21 CFR 123.11(b) 48 Sanitation monitoring documentation Your sanitation control records do not accurately document the conditions or practices observed at your firm.  Specifically***
1571 21 CFR 110.35(d)(5) 47 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, ***
15641 21 CFR 111.453 47 Written procedures - holding You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, ***
1406 21 CFR 110.10(b)(6) 46 Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner.  Specifically, ***
3659 21 CFR 110.37(e)(3) 46 Hand drying Lack of a sanitary towel service or suitable hand drying devices.  Specifically, ***
1402 21 CFR 110.10(b)(4) 45 Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers].  Specifically, ***
15830 21 CFR 111.70(b)(2) 45 Specifications-component purity, strength, composition You did not establish component specifications for [purity] [strength] [composition].  Specifically, ***
15809 21 CFR 111.570(b)(1) 44 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, ***
1005 21 CFR 110.10(b)(7) 40 Storage of personal items Personal [clothing] [belongings] were stored  in an area where [food is exposed] [equipment or utensils are washed].  Specifically, ***
1126 21 CFR 110.40(a) 40 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, ***
3643 21 CFR 110.10(b)(5) 39 Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.  Specifically, ***
1429 21 CFR 110.20(b)(6) 38 Fans/air blowing equipment Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential for contaminating [food] [food-contact surfaces] [food-packaging materials].  Specifically, ***
1426 21 CFR 110.20(b)(5) 37 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, ***
16042 21 CFR 111.503 36 Written procedures - returned dietary supplement You did not [establish] [follow] written procedures for when a returned dietary supplement is received.  Specifically, ***
9931 21 CFR 120.6(b) 35 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, ***
6015 21 CFR 123.6(c)(6) 34 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, ***
15829 21 CFR 111.70(b)(1) 34 Specifications - component identity You did not establish an identity specification for each component.  Specifically, ***
16057 21 CFR 111.535(b)(1) 34 Records - returned dietary supplement: written procedures You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.  Specifically, ***
1067 21 CFR 110.40(c) 33 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, ***
15897 21 CFR 111.83(a) 32 Reserve sample - collect, hold You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.  Specifically, ***
1293 21 CFR 110.20(b)(2) 31 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, ***
1709 21 CFR 110.80(b)(13) 31 Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated.  Specifically, ***
3071 21 CFR 114.80(a)(1) 31 Scheduled process Acidified food is not manufactured in accordance with the scheduled process.  Specifically, ***
15531 21 CFR 111.255(a) 31 Batch record - every batch You did not prepare a batch production record every time you manufactured a batch of dietary supplement.  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, ***
3656 21 CFR 110.37(d)(3) 30 Self-closing doors Toilet facilities lack self-closing doors.  Specifically, ***
15763 21 CFR 111.205(a) 30 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, ***
906 21 CFR 123.6(b) 28 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, ***
3078 21 CFR 114.80(b) 28 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, ***
3654 21 CFR 110.37(d)(1) 28 Maintained Failure to maintain toilet facilities in a sanitary condition.  Specifically, ***
1578 21 CFR 110.37(f) 26 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, ***
1763 21 CFR 110.35(b)(1) 26 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, ***
4464 21 CFR 108.25(c)(1) 26 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, ***
1172 21 CFR 110.40(e) 25 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, ***
1602 21 CFR 110.37(a) 24 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, ***
931 21 CFR 123.8(d) 23 Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
3647 21 CFR 110.10(c) 22 Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].  Specifically, ***
6016 21 CFR 123.6(c)(7) 22 Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points.  Specifically, ***
6010 21 CFR 123.8(a)(3)(i) 21 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, ***
15796 21 CFR 111.430(b) 21 Records - packaging, labeling operations You did not make and keep records of the written procedures for [packaging] [labeling] operations.  Specifically, ***
1289 21 CFR 110.20(a)(3) 20 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, ***
2361 21 CFR 110.80 19 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, ***
6007 21 CFR 123.9(a) 19 Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed.  Specifically, ***
1425 21 CFR 110.20(b)(4) 18 Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].  Specifically, ***
1570 21 CFR 110.35(d)(5) 18 Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, ***
1696 21 CFR 110.80(b)(3) 18 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, ***
15747 21 CFR 111.210(g) 18 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,
15828 21 CFR 111.70(a) 18 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, ***
3062 21 CFR 114.10 17 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, ***
3085 21 CFR 114.100(a) 17 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, ***
4511 21 CFR 108.25(f) 17 Approved school Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
6006 21 CFR 123.6(c)(7) 17 Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring.  Specifically, ***
9930 21 CFR 120.6(c) 17 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, ***
15838 21 CFR 111.70(d) 17 Specifications - labels, packaging You did not establish [label] [packaging] specifications.  Specifically, ***
16013 21 CFR 111.140(b)(1) 17 Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, ***
16118 21 CFR 118.4 17 Written SE plan not implemented/followed Your written SE prevention plan is not [fully] implemented and followed. Specifically,***
1403 21 CFR 110.10(b)(4) 16 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, ***
1561 21 CFR 110.35(c) 16 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, ***
6019 21 CFR 123.8(a)(2) 16 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, ***
15790 21 CFR 111.403 16 Written procedures - labeling operations You did not [establish] [follow] written procedures for labeling operations.  Specifically, ***
16120 21 CFR 118.4 16 Written SE plan lacks required elements Your written SE prevention plan lacks appropriate SE prevention measures.  Specifically,***
16204 21 CFR 118.10(b)(2) 16 Date and time of activity All your required records do not include the [date] [time] of the activity that the records reflect.  Specifically,***
913 21 CFR 123.8(a)(1) 15 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, ***
1598 21 CFR 110.37(b)(4) 15 Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage.  Specifically, ***
3075 21 CFR 114.80(a)(4) 15 Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.  Specifically, ***
12742 21 CFR 120.8(a) 15 HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan.  Specifically, ***
15401 21 CFR 111.12(b) 15 Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations.  Specifically, ***
918 21 CFR 123.8(a) 14 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, ***
1090 21 CFR 110.40(d) 14 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, ***
1596 21 CFR 110.37(b)(2) 14 Convey sewage Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant.  Specifically, ***
2388 21 CFR 110.80(a)(5) 14 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, ***
2393 21 CFR 110.80(b)(1) 14 Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, ***
3067 21 CFR 114.80(a) 13 Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard.  Specifically, "***
4475 21 CFR 108.25(c)(3)(i) 13 Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***
4479 21 CFR 108.25(e) 13 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, ***
9955 21 CFR 120.11(a)(1) 13 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) 13 HACCP plan - food hazards not listed Your HACCP plan does not list all food hazards that are reasonably likely to occur.  Specifically, ***
12746 21 CFR 120.8(b)(2) 13 HACCP plan - critical control points not listed Your HACCP plan does not list the critical control points for each of the identified food hazards.  Specifically, ***
15410 21 CFR 111.14(b)(2) 13 Personnel - records - training You did not make and keep documentation of training.  Specifically, ***
15453 21 CFR 111.16 13 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, ***
15492 21 CFR 111.25(a) 13 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, ***
15736 21 CFR 111.353 13 Manufacturing operations - written procedures You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, ***
16135 21 CFR 118.4(b)(4) 13 Stray animals Stray animals are not prevented from entering poultry houses.  Specifically,***
975 21 CFR 123.9(b)(1) 12 Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period.  Specifically, ***
1130 21 CFR 110.40(a) 12 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, ***
1132 21 CFR 110.40(a) 12 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, ***
1316 21 CFR 113.87(c) 12 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, ***
3655 21 CFR 110.37(d)(2) 12 Good repair Failure to keep toilet facilities in good repair.  Specifically, ***
3662 21 CFR 110.37(e)(6) 12 Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food.  Specifically, ***
3877 21 CFR 113.60(c) 12 Coding - required elements The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed]  [period during which packed].  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, ***
15494 21 CFR 111.25(c) 12 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, ***
15543 21 CFR 111.260(c) 12 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, ***
15744 21 CFR 111.210(h)(2) 12 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, ***
15862 21 CFR 111.75(a)(2) 12 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, ***
986 21 CFR 110.10(b)(2) 11 Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.  Specifically, ***
1711 21 CFR 110.80(b)(15) 11 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, ***
2394 21 CFR 110.80(b)(6) 11 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, ***
3712 21 CFR 110.93 11 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, ***
12748 21 CFR 120.8(b)(5) 11 HACCP plan - corrective action plan not included Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected]. Specifically,***
12755 21 CFR 120.11(a)(1)(iv) 11 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, ***
15402 21 CFR 111.12 11 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, ***
15404 21 CFR 111.12(c) 11 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, ***
15831 21 CFR 111.70(b)(3) 11 Specifications - contamination limits You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, ***
15853 21 CFR 111.73 11 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, ***
15930 21 CFR 111.105 11 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, ***
16203 21 CFR 118.10(b)(1) 11 Name and location All required records do not include [your name] [the location of your farm].  Specifically,***
16205 21 CFR 118.10(b)(3) 11 Signatures or initials on operational records All required records do not have the signature or initials of the person performing the operation or creating the record.  Specifically,***
932 21 CFR 123.7(d) 10 Corrective action documentation You do not have records that document corrective actions that were taken.  Specifically, ***
3073 21 CFR 114.80(a)(2) 10 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, ***
3660 21 CFR 110.37(e)(4) 10 Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands.  Specifically, ***
6022 21 CFR 123.12(c) 10 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, ***
12747 21 CFR 120.8(b)(3) 10 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, ***
12749 21 CFR 120.8(b)(6) 10 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, ***
15499 21 CFR 111.27(a) 10 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, ***
15526 21 CFR 111.30(c) 10 Equipment - automated - calibrate, inspect You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance.  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, ***
15748 21 CFR 111.210(f) 10 Master manufacturing record theoretical and expected yield Your master manufacturing record did not include a statement of [the theoretical yield for each point, step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished dietary supplement] [the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made].  Specifically, ***
15761 21 CFR 111.205(b)(1) 10 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, ***
15825 21 CFR 111.65 10 Quality control - quality, dietary supplement You did not implement quality control operations to ensure the quality of the dietary supplement.  Specifically,  ***
15843 21 CFR 111.70(g) 10 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, ***
15871 21 CFR 111.75(c)(2) 10 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, ***
15921 21 CFR 111.95(b)(2) 10 Documentation - supplier qualification You did not make and keep documentation of your qualification of a supplier.  Specifically,  ***
15932 21 CFR 111.105(a) 10 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, ***
16040 21 CFR 111.610(a) 10 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, ***
16058 21 CFR 111.535(b)(2) 10 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, ***
1472 21 CFR 113.83 9 Critical factors not stated Critical factors that may affect the scheduled process are not specified in the scheduled  process.  Specifically, ***
1641 21 CFR 113.100(b) 9 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, ***
1697 21 CFR 110.80(b)(4) 9 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, ***
2396 21 CFR 110.80(b)(6) 9 Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination.  Specifically, ***
3645 21 CFR 110.10(d) 9 Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel  has not been assigned to competent supervisory personnel.  Specifically, ***
9943 21 CFR 120.8(a) 9 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, ***
9954 21 CFR 120.11(a)(1)(iv) 9 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, ***
9958 21 CFR 120.12(c) 9 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, ***
15496 21 CFR 111.27(b) 9 Instruments - calibration You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine intervals or as necessary] to ensure the accuracy and precision of the instruments or controls.  Specifically, ***
15498 21 CFR 111.27(d) 9 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, ***
15746 21 CFR 111.210(h)(1) 9 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, ***
15800 21 CFR 111.560(a)(2) 9 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, ***
15872 21 CFR 111.75(c)(3) 9 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, ***
15882 21 CFR 111.75(h)(2) 9 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, ***
15989 21 CFR 111.127 9 Quality control operations - packaging, labeling You do not have quality control operations for [packaging] [labeling].  Specifically, ***
16070 21 CFR 111.35(b)(2) 9 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, ***
16140 21 CFR 118.4(c)(2) 9 Monitoring for flies The presence of flies is not monitored by appropriate monitoring methods. Specifically,***
1129 21 CFR 110.40(a) 8 Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces.  Specifically, ***
9936 21 CFR 120.7(a) 8 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, ***
9961 21 CFR 120.24(a) 8 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, ***
15425 21 CFR 111.15(i) 8 Hand-washing facilities Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature].  Specifically, ***
15443 21 CFR 111.15(b)(2) 8 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, ***
15544 21 CFR 111.260(d) 8 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, ***
15560 21 CFR 111.260(k)(2) 8 Batch record - label Your batch production records did not include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record.  Specifically, ***
15645 21 CFR 111.455(c) 8 Hold - mix-up, contamination, deterioration You held [components] [dietary supplements] [packaging] [labels] under conditions that  lead to mix-up, contamination, or deterioration. Specifically, ***
15737 21 CFR 111.210(h)(5) 8 Corrective action plans The written instructions in your  master manufacturing did not include instructions for corrective action plans to use when specifications are not met.  Specifically, ***
15784 21 CFR 111.410(c) 8 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, ***
15819 21 CFR 111.55 8 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, ***
15832 21 CFR 111.70(c)(1) 8 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, ***
15986 21 CFR 111.123(b)(2) 8 Quality control - batch, product specifications Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications.  Specifically, ***
16089 FDCA 417(d)(1)(A) 8 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, ***
16134 21 CFR 118.4(b)(3) 8 Cross contamination from people You do not maintain practices that will protect against cross contamination when people move between poultry houses.  Specifically,***
16138 21 CFR 118.4(c)(1) 8 Monitoring for rodents The presence of rodents is not monitored by appropriate monitoring methods.  Specifically,***
929 21 CFR 123.8(b) 7 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, ***
972 21 CFR 123.8(a)(1) 7 Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate.  Specifically, ***
1255 21 CFR 129.20(a) 7 Bottling room separation The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.  Specifically, ***
1566 21 CFR 110.35(d)(4) 7 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, ***
1568 21 CFR 110.35(d)(2) 7 Before use and after interruption Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been contaminated], to preclude contamination with microorganisms.  Specifically, ***
1601 21 CFR 110.37(a) 7 Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.  Specifically, ***
1761 21 CFR 129.80(a) 7 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, ***
2274 21 CFR 129.80(g)(1) 7 Bacteriological You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled drinking water produced during a day's production run].  Specifically, ***
2384 21 CFR 110.80(a)(7) 7 Receipt/storage - liquid and dry raw materials Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination.  Specifically, ***
3088 21 CFR 114.100(b) 7 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, ***
3653 21 CFR 110.37(d) 7 Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, ***
4181 21 CFR 113.89 7 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, ***
4519 21 CFR 108.35(c)(3)(i) 7 Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***
6014 21 CFR 123.6(c)(2) 7 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,
6017 21 CFR 123.7(c) 7 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, ***
9941 21 CFR 120.8(a) 7 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, ***
9947 21 CFR 120.11(b) 7 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, ***
12734 21 CFR 120.12(a) 7 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, ***
15434 21 CFR 111.15(d)(2) 7 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, ***
15442 21 CFR 111.15(b)(1) 7 Physical plant - clean and sanitary You did not maintain your physical plant in a clean and sanitary condition.  Specifically, ***
15454 21 CFR 111.16 7 Written procedures - pest control You did not [establish] [follow] written procedures for pest control.  Specifically, ***
15546 21 CFR 111.260(f) 7 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, ***
15559 21 CFR 111.260(k)(1) 7 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, ***
15570 21 CFR 111.153 7 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, ***
15583 21 CFR 111.155(d)(1) 7 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,  ***
15681 21 CFR 111.315(d) 7 Standard reference materials; criteria for selecting You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations.  Specifically, ***
15791 21 CFR 111.403 7 Written procedures -packaging operations You did not [establish] [follow] written procedures for packaging operations.  Specifically, ***
15840 21 CFR 111.70(e) 7 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) 7 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,
15885 21 CFR 111.77(a) 7 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, ***
15928 21 CFR 111.103 7 Written procedure quality control operations material review You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision.  Specifically, ***
16122 21 CFR 118.4(a)(2)(i) 7 Pullet environment testing Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age.  Specifically,***
16142 21 CFR 118.4(c)(3) 7 Removal of pest harborages Potential harborages for pests in and outside your poultry house have not been eliminated by [removing debris within a poultry house] [removing debris and vegetation outside the poultry house].  Specifically,***
16152 21 CFR 118.5(a) 7 Testing when laying hens 40 to 45 weeks Environmental testing for SE, using approved methods,  was not done in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age.  Specifically,***
16179 21 CFR 118.8(a) 7 Method to be used, environmental samples For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE.  Specifically,***
16195 21 CFR 118.10(a)(3)(iv) 7 Refrigeration requirements documentation You do not maintain records documenting compliance with refrigeration requirements.  Specifically***
1176 21 CFR 110.40(f) 6 Insufficient number of Q.C. instruments An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms.  Specifically,***
1196 21 CFR 110.10(a) 6 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, ***
1290 21 CFR 110.20(a)(4) 6 Waste disposal Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where food is exposed.  Specifically, ***
1353 21 CFR 129.35(a)(3)(i) 6 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, ***
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, ***
1766 21 CFR 110.35(b)(1) 6 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, ***
2275 21 CFR 129.80(g)(2) 6 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, ***
2385 21 CFR 110.80(a)(1) 6 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, ***
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, ***
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, ***
4062 21 CFR 113.100(a) 6 Critical factors - entry missing information Forms used to record critical factors lack [closing machine vacuum in vacuum-packed products] [maximum fill-in weight] [drained weight] [critical factors specified in the scheduled process].  Specifically, ***
4421 21 CFR 110.20(a) 6 Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, ***
4518 21 CFR 108.35(c)(2)(ii) 6 Process change - increase Failure to file with FDA changes in previously filed scheduled processes, where processing parameters were higher or longer, when the processes became regularly scheduled.  Specifically, ***
4524 21 CFR 108.35(g) 6 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, ***
9928 21 CFR 120.12(b) 6 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, ***
9935 21 CFR 120.7(a) 6 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, ***
15480 21 CFR 111.20(h) 6 Physical plant - screening against pests Your physical plant did not use adequate screening or other protection against pests.  Specifically, ***
15505 21 CFR 111.27(a)(3)(v) 6 Equipment - protect from contamination Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated.  Specifically, ***
15533 21 CFR 111.255(c) 6 Batch record - follow master Your batch production record did not accurately follow the appropriate master manufacturing record.  Specifically, ***
15566 21 CFR 111.260(l)(3) 6 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, ***
15733 21 CFR 111.365 6 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, ***
15734 21 CFR 111.360 6 Manufacturing operations - sanitation You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, ***
15759 21 CFR 111.205(b)(2) 6 Master manufacturing record - controls, procedures Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,  ***
15883 21 CFR 111.75(i) 6 Corrective action plan You did not establish a corrective action plan to use when an established specification is not met.  Specifically, ***
15898 21 CFR 111.83(b)(1) 6 Reserve sample -container-closure system Your reserve sample of a dietary supplement was not held using the same container-closure system in which the packaged and labeled dietary supplement was distributed.  Specifically, ***
16149 21 CFR 118.4(e) 6 Egg transport temperature/time Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay.  Specifically,***
16206 21 CFR 118.10(b)(3) 6 Signature and date on SE plans Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s) who administer the plan].  Specifically,***
950 21 CFR 123.12(d) 5 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, ***
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, ***
1471 21 CFR 113.83 5 Scheduled processes not established Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing.  Specifically, ***
1529 21 CFR 113.89 5 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, ***
1642 21 CFR 113.100(b) 5 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, ***
1688 21 CFR 110.80 5 Supervisory competence The function of supervising overall sanitation of the plant has not been designated to  the supervision of  one or more competent individuals assigned responsibility for this function.  Specifically, ***
1708 21 CFR 110.80(b)(12) 5 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, ***
2362 21 CFR 110.80 5 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, ***
2887 21 CFR 113.40(j) 5 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, ***
3077 21 CFR 114.80(b) 5 Visible code Each container is not marked with an identifying code permanently visible to the naked eye.  Specifically, ***
3090 21 CFR 114.100(d) 5 Product distribution Records identifying initial distribution of finished product are not maintained.  Specifically, ***
3708 21 CFR 110.80(a)(1) 5 Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].  Specifically, ***
3709 21 CFR 110.80(a)(1) 5 Inspection of containers and carriers upon receipt Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does not contribute to the contamination or deterioration of food.  Specifically, ***
4295 21 CFR 110.40(a) 5 Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials.  Specifically, ***
4514 21 CFR 108.35(c)(1) 5 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, ***
6009 21 CFR 123.8(a)(3)(iii) 5 Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made.  Specifically, ***
9919 21 CFR 120.10(a) 5 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, ***
9932 21 CFR 120.6(a) 5 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, ***
12743 21 CFR 120.8(b)(4) 5 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, ***
12751 21 CFR 120.8(b)(7) 5 HACCP plan - recordkeeping system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points.  Specifically, ***
15382 21 CFR 111.8 5 Written procedures - personnel qualifications You did not [establish] [follow] written procedures for determining personnel qualification requirements.  Specifically, ***
15491 21 CFR 111.25 5 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, ***
15525 21 CFR 111.30(b) 5 Equipment - automated - suitability You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process.  Specifically, ***
15542 21 CFR 111.260(b) 5 Batch record - date, time; maintenance Your batch production records did not include the identity of equipment and processing lines used in producing the batch.  Specifically, ***
15578 21 CFR 111.155(c) 5 Components - quarantine You did not quarantine components before you used them in the manufacture of a dietary supplement.  Specifically, ***
15598 21 CFR 111.160(d)(1) 5 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, ***
15623 21 CFR 111.180(b)(2) 5 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,  ***
15702 21 CFR 111.320(b) 5 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, ***
15715 21 CFR 111.375(b) 5 Records - manufacturing operations; written procedures You did not make and keep records of the written procedures for manufacturing operations.  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, ***
15739 21 CFR 111.210(h)(3)(ii)(B) 5 Components; add, verify The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person to add and another person to verify the addition of the components.  Specifically, ***
15751 21 CFR 111.210(d) 5 Master manufacturing record - Supplemental Facts Your master manufacturing record did not include the [identity] [weight or measure] of each dietary ingredient that will be declared on the Supplement Facts label.  Specifically, ***
15760 21 CFR 111.205(b)(1) 5 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) 5 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, ***
15786 21 CFR 111.410(b) 5 Labels - issuance, use You did not control the [issuance] [use] of labels, Specifically, ***
15810 21 CFR 111.570(b)(2) 5 Record - product complaint; good manufacturing practice You did not make and keep a written record of every product complaint that was related to good manufacturing practice.  Specifically, ***
15860 21 CFR 111.75(a)(2) 5 Component - confirm identity; specifications met You did not confirm the identity of components.  Specifically, ***
15867 21 CFR 111.75(b)(1) 5 Specifications met, in-process - quality finished batch You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met.  Specifically, ***
15893 21 CFR 111.80(c) 5 Specifications - representative samples; finished batch You did not collect representative samples [of a subset] of finished batches of dietary supplements that you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement meets established product specifications.  Specifically, ***
15902 21 CFR 111.83(b)(4) 5 Reserve sample - twice the quantity Your reserve sample did not consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.  Specifically, ***
15920 21 CFR 111.95(b)(1) 5 Records - established specifications You did not make and keep records of established specifications.  Specifically, ***
15954 21 CFR 111.113(a)(2) 5 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, ***
15977 21 CFR 111.123(a)(1) 5 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, ***
16014 21 CFR 111.140(b)(1) 5 QC ops; written procedures; material review, disposition You did not make and keep [written procedures for the responsibilities of the quality control operations for conducting a material review and making a disposition decision] [written procedures for approving or rejecting any reprocessing].  Specifically, ***
16037 21 CFR 111.605 5 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, ***
16047 21 CFR 111.510 5 Returned dietary supplement - material review, disposition You did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision.  Specifically, ***
16071 21 CFR 111.35(b)(3) 5 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, ***
16132 21 CFR 118.4(b)(1) 5 Limiting visitors Visitors are not limited [on the farm] [in the poultry houses].  Specifically,***
938 21 CFR 123.9(c) 4 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, ***
1351 21 CFR 129.35(a)(3)(i) 4 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, ***
1423 21 CFR 129.37(d) 4 Containers kept sanitary You do not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude contamination of the bottled drinking water.  Specifically, ***
1453 21 CFR 129.40(a)(1) 4 Suitability - equipment and utensils Not all plant equipment and utensils are suitable for their intended use.  Specifically, ***
1559 21 CFR 110.35(c) 4 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, ***
1563 21 CFR 110.35(d)(1) 4 Low-moisture food requirements Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use.  Specifically, ***
1577 21 CFR 110.37(f) 4 Contamination of food, contact surfaces, water supplies, etc The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces].  Specifically, ***
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, ***
1651 21 CFR 113.40(a)(1) 4 Thermometer calibration Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon installation] [yearly] to ensure accuracy.  Specifically, ***
2848 21 CFR 113.40(g)(1)(i)(b) 4 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] a known accurate mercury-in-glass thermometer.  Specifically, ***
3082 21 CFR 114.89 4 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, ***
4476 21 CFR 108.25(c)(3)(ii) 4 Process information availability Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, ***
9939 21 CFR 120.7(c) 4 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, ***
9981 21 CFR 120.12(b)(4) 4 Records - actual values Your records do not [always] contain the actual values and observations obtained during monitoring.  Specifically, ***
12732 21 CFR 120.10(a) 4 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, ***
15388 21 CFR 111.10(b) 4 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, ***
15447 21 CFR 111.15(c)(3) 4 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) 4 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, ***
15458 21 CFR 111.20(d)(1)(i) 4 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, ***
15481 21 CFR 111.23(b) 4 Records - cleaning, pest control You did not make and keep records of the written procedures for [cleaning the physical plant] [pest control].  Specifically, ***
15508 21 CFR 111.27(a)(5)(ii) 4 Refrigerator, freezer - alarm Your freezer, refrigerator, or other cold storage compartments that you use to hold components or dietary supplements does not have either an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change.  Specifically, ***
15547 21 CFR 111.260(g) 4 Batch record - results; monitoring Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,  ***
15550 21 CFR 111.260(j) 4 Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, ***
15556 21 CFR 111.260(j)(2)(iv) 4 Batch record - initials; verifying component Your batch production records did not include initials of the person responsible for verifying the addition of components to the batch.  Specifically, ***
15558 21 CFR 111.260(k)(1) 4 Batch record - identifier; packaging Your batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used].  Specifically, ***
15562 21 CFR 111.260(l)(1) 4 Batch record - quality control review; production Your batch production records did not include documentation that quality control personnel reviewed the batch production record.  Specifically, ***
15599 21 CFR 111.160(d)(1) 4 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, ***
15662 21 CFR 111.303 4 Written procedures - laboratory operations You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
15671 21 CFR 111.315 4 Laboratory control  processes - requirements You did not [establish] [follow] laboratory control processes.  Specifically, ***
15698 21 CFR 111.320(a) 4 Examination, testing; appropriate You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.  Specifically, ***
15740 21 CFR 111.210(h)(3)(ii)(A) 4 Instructions; components; weight, measure The specific actions in your written instructions in your master manufacturing record for a manual operation did not include one person weighing or measuring and another person verifying the weight or measure of components.  Specifically, ***
15743 21 CFR 111.210(h)(3) 4 Master manufacturing record - specific actions; quality The written instructions in your master manufacturing record did not include specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.  Specifically, ***
15783 21 CFR 111.410(d) 4 Manufacturing history You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution.  Specifically, ***
15799 21 CFR 111.560(a)(1) 4 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, ***
15834 21 CFR 111.70(c)(2) 4 Specifications identity, purity strength, composition You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for [the identity] [purity] [strength] [composition].  Specifically, ***
15842 21 CFR 111.70(f) 4 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, ***
15855 21 CFR 111.73 4 Specifications met - received product identified You did not determine whether you met established specifications to provide sufficient assurance that product you receive from a supplier is adequately identified and is consistent with your purchase order.  Specifically, ***
15864 21 CFR 111.75(a)(2)(ii)(C) 4 Documentation - qualify supplier You did not maintain documentation of how you qualified the supplier of a component.  Specifically, ***
15865 21 CFR 111.75(a)(2)(ii)(D) 4 Re-confirm certificate of analysis You did not periodically re-confirm the supplier's certificate of analysis for a component.  Specifically, ***
15870 21 CFR 111.75(c)(1) 4 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, ***
15972 21 CFR 111.120(b) 4 QC operations -specifications; components, packaging, labels Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications.  Specifically,  ***
15975 21 CFR 111.120(e) 4 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, ***
15984 21 CFR 111.123(a)(8) 4 Quality control - finished batch, distribution Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution.  Specifically, ***
16172 21 CFR 118.7(a) 4 Plan appropriate to layout The poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,***
16192 21 CFR 118.10(a)(3)(1) 4 Biosecurity measures documentation You did not maintain records documenting compliance with biosecurity measures.  Specifically,***
976 21 CFR 123.9(b)(2) 3 Process adequacy records The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their applicability to the product you produced.  Specifically, ***
1317 21 CFR 113.87(d) 3 Timing devices Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved.  Specifically, ***
1330 21 CFR 113.100(a) 3 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, ***
1467 21 CFR 129.40(a)(2) 3 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, ***
1500 21 CFR 113.89 3 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  Specifically, ***
1643 21 CFR 113.100(c) 3 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, ***
1648 21 CFR 113.40(a)(1) 3 No MIG thermometer Failure to install a mercury-in glass thermometer on each retort.  Specifically, ***
1669 21 CFR 110.80(a)(3) 3 Aflatoxin and other natural toxins There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food.  Specifically, ***
1670 21 CFR 110.80(a)(4) 3 Safety assurance - pests/extraneous materials There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels.  Specifically, ***
1764 21 CFR 129.80(b)(1) 3 Multiservice primary containers You do not adequately [clean] [sanitize] [inspect] multiservice primary containers just prior to the containers being filled, capped and sealed.  Specifically, ***
1812 21 CFR 129.80(c) 3 Testing of cleaning/sanitizing solutions You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, ***
2391 21 CFR 110.80(a)(6) 3 Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated.  Specifically, ***
2427 21 CFR 110.80(b)(9) 3 Proper disposal of adulterated product Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food.  Specifically, ***
2837 21 CFR 113.40(g)(4) 3 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, ***
3093 21 CFR 114.89 3 Process deviation evaluation - record Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations].  Specifically, ***
3857 21 CFR 113.60(a) 3 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) 3 Closures other than double seams and glass Failure to [have a qualified person] perform appropriate detailed inspections and tests [at intervals of sufficient frequency] to ensure proper closing machine performance and consistently reliable hermetic seal production.  Specifically, ***
4296 21 CFR 110.80(a)(5) 3 Temperature and humidity Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated.  Specifically, ***
4520 21 CFR 108.35(c)(3)(ii) 3 Process information availability Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, ***
6012 21 CFR 123.8(a)(3)(iii) 3 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, ***
9926 21 CFR 120.14(a) 3 Importer - written procedures You do not have written procedures that describe [product specifications] [affirmative steps] to ensure that juice you receive for import into the United States was processed in accordance with the juice HACCP regulation.  Specifically, ***
9929 21 CFR 120.12(b)(4) 3 Records - information not entered when observed Processing and other information is not [always] entered on your records at the time it is observed.  Specifically, ***
9986 21 CFR 120.24(c) 3 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, ***
12709 21 CFR 129.80(c) 3 Records of cleaning/sanitizing solutions You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions.  Specifically, ***
12744 21 CFR 120.8(b)(4) 3 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, ***
15396 21 CFR 111.10(b)(6) 3 Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, ***
15405 21 CFR 111.13(a) 3 Supervisor - qualified You have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling] [holding] of dietary supplements].  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, ***
15433 21 CFR 111.15(d)(1) 3 Animals and pests in facility You allowed [animals] [pests] in your physical plant. Specifically, ***
15469 21 CFR 111.20(c)(3) 3 Physical plant - separate areas for products You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplement  by separating the [manufacturing] [packaging] [labeling] [holding] of different product types.  Specifically, ***
15493 21 CFR 111.25(b) 3 Procedures - calibrating automated, mechanical equip You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.  Specifically, ***
15524 21 CFR 111.30(a) 3 Equipment - automated - design, selection You did not design or select automated, mechanical, or electronic equipment that you use to [manufacture] [package] [label] [hold] a dietary supplement to ensure that the dietary supplement specifications are consistently met.  Specifically, ***
15589 21 CFR 111.160(c) 3 Packaging, labels - quarantine You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary supplement.  Specifically, ***
15619 21 CFR 111.180(b)(1) 3 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, ***
15620 21 CFR 111.180(b)(1) 3 Written procedures - product received You did not make and keep written procedures for fulfilling the requirements that apply to product received for packaging or labeling as a dietary supplement and for distribution rather than for return to the supplier.  Specifically,
15648 21 CFR 111.465(a)(2) 3 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, ***
15652 21 CFR 111.465(b) 3 Retain reserve samples - 1 year, 2 years You did not retain reserve samples for the required time.  Specifically, ***
15660 21 CFR 111.475(b)(2) 3 Records - product distribution You did not make and keep records of product distribution.  Specifically, ***
15665 21 CFR 111.303 3 Written procedures - tests, examinations; specifications met You did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met.  Specifically, ***
15675 21 CFR 111.315(b) 3 Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, ***
15677 21 CFR 111.315(b)(1) 3 Sampling plans; components You did not [establish] [follow] sampling plans for obtaining representative samples of components.  Specifically, ***
15732 21 CFR 111.365(a) 3 Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination].  Specifically, ***
15741 21 CFR 111.210(h)(3)(i) 3 Components, verify weight,  measure The written instructions in your master manufacturing record did not include instructions to verify the weight or measure and addition of components.  Specifically,  ***
15772 21 CFR 111.415(g) 3 Representative sample - packaged, labeled dietary supplement You did not examine a representative sample of each batch of packaged and labeled dietary supplement to determine whether the dietary supplement meets established specifications.  Specifically,  ***
15801 21 CFR 111.560(b) 3 Quality control, review, approve; investigate, follow-up Your quality control personnel did not [review and approve decisions about whether to investigate a product complaint] [review and approve the findings and follow-up action of an investigation].  Specifically, ***
15817 21 CFR 111.570(b)(2)(ii)(F) 3 Record - product complaint; findings The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken].  Specifically, ***
15820 21 CFR 111.55 3 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, ***
15845 21 CFR 111.73 3 Specifications met - quality You did not determine whether you met specifications established to ensure the quality of the dietary supplement.  Specifically, ***
15891 21 CFR 111.80(a) 3 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, ***
15903 21 CFR 111.87 3 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) 3 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, ***
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, ***
15945 21 CFR 111.105(i) 3 QC - required operations packaging/labeling operations Your quality control personnel did not perform required operations for [packaging] [labeling] operations. Specifically, ***
15953 21 CFR 111.113(a)(1) 3 QC production, process control; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.  Specifically, ***
15955 21 CFR 111.113(a)(3) 3 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, ***
15964 21 CFR 111.113(c) 3 Document - material review, disposition The person who conducted a material review and made the disposition decision did not document the material review and the disposition decision [at the time of performance].  Specifically, ***
15965 21 CFR 111.117 3 Quality control operations - equipment, instruments, control You do not have quality control operations for [equipment] [instruments] [controls].  Specifically, ***
15983 21 CFR 111.123(a)(7) 3 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) 3 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, ***
16038 21 CFR 111.605(b) 3 Records - original, true copies You did not keep original records, true copies, or electronic records. Specifically,   ***
16045 21 CFR 111.503 3 Written procedures returned dietary supplement; reprocessing You did not [establish] [follow] written procedures for quality control personnel to approve a returned dietary supplement for reprocessing.  Specifically, ***
16068 21 CFR 111.35(b)(1)(iii) 3 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, ***
16117 21 CFR 118.4 3 No written SE prevention plan Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you produce eggs.  Specifically,***
16133 21 CFR 118.4(b)(2) 3 Cross contamination from equipment You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses.  Specifically,***
16141 21 CFR 118.4(c)(2) 3 Satisfactory fly control methods When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control.  Specifically,***
16191 21 CFR 118.10(a)(2) 3 Pullets records documentation You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE monitored" conditions] [that adequate environmental testing records for pullets were kept as required by CFR regulations].  Specifically,***
16193 21 CFR 118.10(a)(3)(ii) 3 Rodent and pest control documentation You did not maintain records documenting compliance with rodent and other pest control measures.  Specifically,***
16194 21 CFR 118.10(a)(3)(iii) 3 Depopulation cleaning and disinfection procedures You did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation. Specifically,***
899 21 CFR 123.16 2 Process controls Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***
949 21 CFR 123.12(c) 2 Records, English The records that document the performance and results of the affirmative step you chose are not in English.   Specifically, ***
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, ***
1188 21 CFR 110.37(c) 2 Sewage disposal Failure to dispose of sewage into an adequate sewerage system or by other adequate means.  Specifically, ***
1258 21 CFR 113.60(c) 2 Coding - visible Hermetically sealed containers do not have an identifying code permanently visible to the naked eye.  Specifically ***
1273 21 CFR 129.20(b) 2 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, ***
1278 21 CFR 129.20(d) 2 Placement of washing/sanitizing ops The [washing] [sanitizing] operation for containers for bottled drinking water is not positioned within the room so as to minimize any possible post-sanitation contamination of the containers before they enter the bottling room. Specifically, ***
1329 21 CFR 113.100(a) 2 Processing entries not done/not timely Required information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person.  Specifically, ***
1359 21 CFR 129.35(a)(3)(i) 2 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, ***
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, ***
1483 21 CFR 113.87(a) 2 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, ***
1499 21 CFR 113.89 2 No corrective action taken No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a deviation from the scheduled process was found.  Specifically, ***
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, ***
1660 21 CFR 113.40(a)(1) 2 MIG thermometer not used as reference The mercury-in-glass thermometer was not the reference thermometer for indicating processing temperatures.   Specifically, ***
1710 21 CFR 110.80(b)(14) 2 Water activity controls Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms.  Specifically, ***
1731 21 CFR 113.40(a)(2) 2 Presence and accuracy Each retort did not have an accurate temperature-recording device.    Specifically, ***
1734 21 CFR 113.40(a)(2) 2 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing.  Specifically, ***
1752 21 CFR 113.40(a)(8) 2 Location - from ends Bleeders on horizontal retorts are not installed [approximately one foot from the outermost end at both ends of the retort] [on top of the retort].  Specifically, ***
1806 21 CFR 129.80(b)(1) 2 Records of mechanical washers You do not keep records of [inspection and conditions found] [physical maintenance] [performance] for mechanical washers.  Specifically, ***
1944 21 CFR 129.80(d) 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, ***
1962 21 CFR 129.80(h) 2 Two year requirement You did not retain at the plant required records for at least 2 years.  Specifically, ***
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, ***
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, ***
2284 21 CFR 129.80(f) 2 Inspection of filled containers You do not visually or electronically inspect filled containers to assure they are [sound] [properly capped or sealed] [properly coded and labeled].  Specifically, ***
2387 21 CFR 110.80(a)(1) 2 Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.  Specifically, ***
2389 21 CFR 110.80(a)(5) 2 Identify rework Failure to identify material scheduled for rework as such. Specifically, ***
2502 21 CFR 113.40(e)(2) 2 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing.  Specifically, ***
2514 21 CFR 113.40(e)(7) 2 Minimum headspace Minimum headspace of containers in each retort load to be processed was not [measured] [recorded] at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process.  Specifically, ***
2838 21 CFR 113.40(g)(1)(i)(a) 2 Presence and accuracy Each product sterilizer does not have a mercury-in glass thermometer (MIG) or equivalent temperature-indicating device.  Specifically, ***
2898 21 CFR 113.40(g)(2)(ii)(c) 2 Sufficient frequency Observations and measurements of operating conditions were not [made] [recorded] at intervals of sufficient frequency to ensure commercial sterility.  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,  ***
3072 21 CFR 114.80(a)(1) 2 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, ***
3079 21 CFR 114.80(b) 2 Code - packing period The packing period is not changed often enough to enable ready identification of lots during sale and distribution  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, ***
3650 21 CFR 110.35(d)(1) 2 Wet cleaning Failure to sanitize and thoroughly dry, prior to use,  food-contact surfaces which have been wet cleaned.  Specifically, ***
3657 21 CFR 110.37(d)(4) 2 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, ***
3856 21 CFR 113.60(a) 2 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 ***
3864 21 CFR 113.60(a)(1) 2 Recording of teardown examinations Failure to record teardown examinations of double seam cans [at intervals of sufficient frequency] [on enough containers from each seaming station] to ensure maintenance of seam integrity.  Specifically, ***
3876 21 CFR 113.60(c) 2 Coding - failure to mark Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye.  Specifically, ***
3885 21 CFR 113.87(c) 2 IT of cans in water filled retorts Failure to assure that the initial temperature of cans exposed to water during filling or operating of the retort was not lower than the initial temperature specified in the scheduled process.  Specifically, ***
4178 21 CFR 113.83 2 Commercial production variations Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled process.  Specifically, ***
6002 21 CFR 123.11(b) 2 Sanitation corrections You did not correct sanitation deficiencies in a timely manner.  Specifically,***
9946 21 CFR 120.11(b) 2 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, ***
12733 21 CFR 120.11(a)(1)(iv)(C) 2 Calibration, testing - record review timeliness You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records within a reasonable time after the records were made.  Specifically, ***
12736 21 CFR 120.12(e) 2 Records - review and copying You did not make all required records available for review and copying at reasonable times.  Specifically, ***
12750 21 CFR 120.8(b)(6) 2 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, ***
15302 21 CFR 120.11(a)(2) 2 Calibration, testing - no records You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, ***
15304 21 CFR 120.12(g) 2 Records - computerized Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  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, ***
15395 21 CFR 111.10(b)(5) 2 Gloves Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable material].  Specifically, ***
15423 21 CFR 111.15(j) 2 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, ***
15429 21 CFR 111.15(k) 2 Sanitation supervisors - assigned You did not assign one or more employees to supervise overall sanitation.  Specifically, ***
15437 21 CFR 111.15(a)(1) 2 Grounds - equipment, litter, weeds You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant.  Specifically, ***
15450 21 CFR 111.15(f)(3) 2 Plumbing - source of contamination The plumbing in your physical plant was not adequate to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface or creating an unsanitary condition.  Specifically, ***
15468 21 CFR 111.20(c)(2) 2 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, ***
15501 21 CFR 111.27(a)(3)(i) 2 Equipment - installed to facilitate cleaning Your equipment or utensils were not [installed] [maintained] to facilitate cleaning of [the equipment] [the utensils] [all adjacent spaces].  Specifically, ***
15511 21 CFR 111.27(d) 2 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, ***
15529 21 CFR 111.30(e) 2 Equipment - controls, intended use You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use.  Specifically, ***
15545 21 CFR 111.260(e) 2 Batch record - component; identity, weight Your batch production records did not include the [identity] [weight or measure] of each component used.  Specifically, ***
15548 21 CFR 111.260(h) 2 Batch record - results; testing, examination; batch Your batch production records did not include the results of testing or examination performed during batch production, or a cross-reference to such results.  Specifically, ***
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, ***
15554 21 CFR 111.260(j)(2)(ii) 2 Batch record - initials; verifying weight Your batch production records did not include the initials of the person responsible for verifying the weight or measure of each component used in the batch.  Specifically, ***
15557 21 CFR 111.260(k) 2 Batch record - packaging, labeling Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations.  Specifically, ***
15564 21 CFR 111.260(l)(1)(ii) 2 Batch record - quality control; tests, examinations Your batch production records did not include documentation that quality control personnel reviewed the results of tests and examinations.  Specifically, ***
15567 21 CFR 111.260(l)(4) 2 Batch record - approved, released, rejected Your batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement.  Specifically, ***
15569 21 CFR 111.260(n) 2 Batch record - reprocessing Your batch production records did not include documentation of reprocessing.  Specifically, ***
15572 21 CFR 111.153 2 Written procedures - labels You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, ***
15573 21 CFR 111.153 2 Written procedures - product received; packaging, labeling You did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement.  Specifically, ***
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, ***
15585 21 CFR 111.155(d)(2) 2 Components - unique identifier You did not use a unique identifier whenever you recorded the disposition of [each unique lot within each unique shipment of components that you received] [each lot of components that you produced].  Specifically, ***
15586 21 CFR 111.155(e) 2 Components - contamination, deterioration, mix-ups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  Specifically, ***
15606 21 CFR 111.165(c)(1) 2 Product received - quarantine; representative samples You did not collect representative samples of received product while the received product was quarantined.  Specifically, ***
15607 21 CFR 111.165(c)(2) 2 Product received - quality control; documentation; specs Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.  Specifically,  ***
15626 21 CFR 111.180(b)(3) 2 Documentation - packaging You did not make and keep documentation that the requirements that apply to production and process control for packaging received were met.  Specifically, ***
15646 21 CFR 111.460(a) 2 Hold, identify - in-process material You did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration.  Specifically, ***
15728 21 CFR 111.365(d) 2 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, ***
15745 21 CFR 111.210(h)(1) 2 Instructions; specifications; packaged, labeled The written instructions in your master manufacturing record did not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically,  ***
15749 21 CFR 111.210(e) 2 Master manufacturing record - intentional overage Your master manufacturing record did not include a statement of intentional overage amount of a dietary ingredient.  Specifically, ***
15750 21 CFR 111.210(d) 2 Master manufacturing record - ingredients list Your master manufacturing record did not include the identity of each ingredient that will be declared on the ingredients list of the dietary supplement.  Specifically, ***
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, ***
15754 21 CFR 111.210(a) 2 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, ***
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, ***
15769 21 CFR 111.420(b) 2 Repackaged, relabeled - specifications You did not examine a representative sample of each batch of [repackaged] [relabeled] dietary supplement to determine whether the established specifications were met.  Specifically, ***
15779 21 CFR 111.415(a) 2 Clean, sanitize - filling, packaging equipment You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement packaging], as appropriate.  Specifically, ***
15785 21 CFR 111.410(b) 2 Label, packaging - discrepancies You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].  Specifically,  ***
15788 21 CFR 111.410(a) 2 Packaging - specifications You did not take necessary actions to determine whether packaging for dietary supplements meets specifications so that the condition of the packaging will ensure the quality of your dietary supplements. Specifically, ***
15803 21 CFR 111.560© 2 Product complaint -investigate, findings, follow-up Your [review about whether to investigate a product complaint] [findings and follow-up action of an investigation performed] did not extend to all relevant batches and records.  Specifically, ***
15850 21 CFR 111.73 2 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, ***
15878 21 CFR 111.75(e) 2 Product - visually examine, identified You did not [visually examine a product that you received for packaging or labeling] [have documentation that the product you received for packaging or labeling is adequately identified and is consistent with your purchase order].  Specifically, ***
15886 21 CFR 111.77(b) 2 Specifications not met - identity; component, reject Your quality control personnel did not reject a component that did not meet an identity specification.  Specifically,  ***
15892 21 CFR 111.80(b) 2 Specifications - representative samples; in-process material You did not collect representative samples of in-process materials for each manufactured batch as specified in the master manufacturing record to determine whether the in-process materials met established specifications.  Specifically, ***
15894 21 CFR 111.80(d) 2 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, ***
15940 21 CFR 111.105(h) 2 Quality control - production, process control Your quality control personnel did not determine that specifications established for the production and process control system were met.  Specifically, ***
15950 21 CFR 111.110(b) 2 Quality control operations - tests, examinations Your quality control operations did not include ensuring that [tests] [examinations] required for your laboratory operations were conducted.  Specifically, ***
15951 21 CFR 111.110(c) 2 Quality control operations - tests, examinations; results Your quality control operations did not include reviewing and approving the results of required [tests] [examinations].  Specifically, ***
15963 21 CFR 111.113(b)(2) 2 Quality control - reject; specification not met Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met.  Specifically, ***
15973 21 CFR 111.120(c) 2 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, ***
15976 21 CFR 111.123 2 Quality control operations - master, batch, manufacturing You do not have quality control operations required  for the [master manufacturing record] [batch production record] [manufacturing operations].  Specifically, ***
15998 21 CFR 111.127(g) 2 Quality control operations - labeling; relabeling Your quality control operations for labeling did not include approving or rejecting any relabeling of a packaged and labeled dietary supplement.  Specifically, ***
16000 21 CFR 111.130 2 Quality control operations - returned dietary supplement You do not have quality control operations for returned dietary supplements.  Specifically, ***
16001 21 CFR 111.130(a) 2 QC returned dietary supplement; material review, disposition Your quality control operations for returned dietary supplements did not include conducting a required material review and  making a required disposition decision.  Specifically, ***
16004 21 CFR 111.130(b) 2 Returned dietary supplement; salvage, redistribution Your quality control operations for returned dietary supplements did not include approving or rejecting salvage and redistribution of a returned dietary supplement.  Specifically, ***
16020 21 CFR 111.140 (b)(3)(ii) 2 Material review, disposition, follow-up; investigation Your documentation of your material review and disposition decision and follow-up did not include a description of your investigation into the cause of the deviation from the specification or of the unanticipated occurrence.  Specifically, ***
16067 21 CFR 111.35(b)(1)(ii) 2 Procedures - equipment; calibrating, inspecting, checking You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated, mechanical, or electronic equipment.  Specifically, ***
16083 21 CFR 111.35(b)(6) 2 Documentation - equipment functions; intended use You did not make and keep documentation of the controls you use to ensure that equipment functions according to its intended use.  Specifically, ***
16087 21 CFR 111.123(b)(4) 2 QC supplier product released assurance not provided  package Your quality control personnel approved and released for distribution product received from a supplier for [packaging] as a dietary supplement for which sufficient assurance was not provided [to adequately identify the product] [to determine that the product was consistent with your purchase order].  Specifically, ***
16131 21 CFR 118.4(b) 2 Transfer or introduction of SE You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or among poultry houses.  Specifically,***
16136 21 CFR 118.4(b)(5) 2 Employees keeping birds at home Employees are allowed to keep birds at home.  Specifically,***
16183 21 CFR 118.9 2 Supervisor(s) training/job experience Supervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job experience to administer the SE prevention measures].  Specifically,***
16189 21 CFR 118.10(c) 2 Records retention time All records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production.  Specifically,***
16190 21 CFR 118.10(a)(1) 2 Written SE prevention plan You do not have a written SE prevention plan.  Specifically,***
16196 21 CFR 118.10(a)(3)(v) 2 Sampling procedures documentation You did not maintain records documenting compliance with environmental and egg sampling procedures.  Specifically,***
16201 21 CFR 118.10(d) 2 24 hour retrieval of offsite records You are not able to retrieve and provide the records at your place of business within 24 hours of request for official review.  Specifically,***
16207 21 CFR 118.10(b)(4) 2 Data and information re: compliance activities Data and information reflecting compliance activities [is not entered on records at the time the activity is performed or observed] [does not indicate the actual values].  Specifically***
939 21 CFR 123.9(f) 1 Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  Specifically, ***
1044 21 CFR 113.10 1 Container closure inspectors Container closure inspectors are not under the operating supervision of a person that has attended,  and satisfactorily completed, an appropriate  school approved by the Commissioner.  Specifically, ***
1197 21 CFR 110.10(a) 1 Lack of instruction/reporting of health conditions Personnel with  adverse health conditions are not instructed to report to their supervisors.  Specifically, ***
1286 21 CFR 129.35(a) 1 Approved sources The [product] [operations] water [supply is] [supplies are] not from an approved source.  Specifically, ***
1288 21 CFR 110.20(a)(2) 1 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, ***
1303 21 CFR 113.81(f) 1 Critical Factors The critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal process are not controlled in a manner to ensure the limits established are not exceeded.   Specifically, ***
1324 21 CFR 113.100(d) 1 Distribution record Distribution records are not maintained to identify the initial distribution of the finished product.  Specifically, ***
1325 21 CFR 113.100(e) 1 Record retention Copies of processing, production, and other required records for each lot of a low-acid food processed were not retained at the processing plant [for a one year period following manufacture] [or other reasonably accessible location for a total of a three-year record-retention period].  Specifically, ***
1334 21 CFR 113.100(a)(4) 1 Aseptic processing Forms used in recording specific processing and production information for aseptic processing and packaging systems lack [the product temperature in the holding tube outlet] [the product temperature in the final heater outlet] [differential pressure] [product flow rate] [sterilization media flow rate] [sterilization media temperature] [retention time of containers and closures] [sterilization cycle times] [sterilization cycle temperatures].  Specifically, ***
1379 21 CFR 129.35(a)(4)(iv) 1 Compliance with standards Finished bottled water does not comply with bottled water quality standards.  Specifically, ***
1383 21 CFR 129.35(c) 1 Lockers and lunchrooms A [locker] [lunchroom] for the employees [is] [are] not [separated from plant operations and storage areas] [equipped with self-closing doors] [equipped with refuse containers] [maintained in a clean and sanitary condition] [free of stored packaging or wrapping material or other processing supplies].  Specifically, ***
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, ***
1412 21 CFR 129.37(b) 1 Transport and storage After cleaning, you do not [transport] [store] all [multiservice containers] [utensils] [disassembled piping and equipment] in such a manner as to [assure drainage] [be protected from contamination]. Specifically, ***
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, ***
1473 21 CFR 113.83 1 Scientific methods not performed No acceptable scientific methods of establishing heat sterilization processes or procedures recognized by competent processing authorities were used in the determination of the scheduled process.  Specifically, ***NOTE: CFSAN CONCURRENCE REQUIRED.
1484 21 CFR 113.87(a) 1 Vent not posted Retort venting procedures for each product and container size were not [posted in a conspicuous place near the processing equipment] [readily available to the retort or processing system operator] [readily available to FDA investigators].  Specifically, ***
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, ***
1531 21 CFR 113.100(a)(6) 1 Water activity Forms used in recording specific processing and production information for food preservation methods such as water activity in conjunction with thermal processing lack [product formulation] [scheduled processes used] [thermal process] [associated and other critical factors] [results of water activity determinations].  Specifically, ***
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, ***
1533 21 CFR 113.100(b) 1 RTC identification Recording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed].  Specifically ***
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, ***
1640 21 CFR 113.100(b) 1 Entries not signed The retort or processing system operator or other designated person did not initial or sign each record form.   Specifically, ***
1645 21 CFR 113.100(c) 1 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, ***
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, ***
1665 21 CFR 110.80(a)(2) 1 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, ***
1706 21 CFR 110.80(b)(10) 1 Mechanical manufacturing control Failure to perform mechanical manufacturing steps so as to protect food against contamination.  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, ***
1735 21 CFR 113.40(a)(2) 1 Unauthorized adjustment There was no means to prevent unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
1740 21 CFR 113.40(a)(2) 1 Well bleeder Failure to have a 1/16-inch or larger bleeder.  Specifically, ***
1757 21 CFR 113.40(a)(8) 1 Observable Failure to install bleeders so that the operator can observe that they are functioning properly.  Specifically, ***
1762 21 CFR 129.80(a) 1 Samples and analyses Methods used to analyze product water samples are not those approved by the government agencies with jurisdiction over the product.  Specifically, ***
1855 21 CFR 113.40(a)(12) 1 Installation Vents are not installed so as to provide complete removal of air from a retort before the process start time.  Specifically, ***
1865 21 CFR 113.40(a)(12) 1 Short vent Timing of a process began before the retort [was properly vented] [processing temperature was reached]. 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, ***
2105 21 CFR 113.40(a)(13)(iv) 1 Can positioning Failure to position containers in the retort according to the scheduled process, for products in which stratification or layering occurs.  Specifically, ***
2111 21 CFR 113.40(b)(4) 1 Steam controller Failure to equip a retort with an automatic steam controller to maintain retort temperatures.  Specifically, ***
2142 21 CFR 113.40(b)(1) 1 No MIG thermometer Failure to install a mercury-in glass thermometer on each retort.  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, ***
2145 21 CFR 113.40(b)(1) 1 Defective thermometer A retort was used without replacing or repairing a mercury-in-glass thermometer [with a divided column] [that could not be adjusted to the standard].  Specifically, ***
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, ***
2152 21 CFR 113.40(b)(2) 1 Scale The working scale of the temperature-recording device chart was more than 55 degrees F per inch, within a range of 20 degrees F of the processing temperature.  Specifically, ***
2153 21 CFR 113.40(b)(2) 1 Corresponding with MIG Failure to properly adjust the temperature-recording device.  The temperature recorded on the temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass thermometer during processing.  Specifically, ***
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, ***
2271 21 CFR 129.80(e) 1 Package identification You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production code which identifies [the particular batch] [the segment of production run] [the day produced].  Specifically, ***
2272 21 CFR 129.80(e) 1 Plant records You do not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of finished product to wholesale and retail outlets].  Specifically, ***
2298 21 CFR 129.80(f) 1 Inspection of containers and closures You do not [sample] [inspect] all containers and closures to ascertain they are free from contamination.  Specifically, ***
2344 21 CFR 113.40(c)(7) 1 Unauthorized changes There is no means of preventing unauthorized speed changes on retorts  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, ***
2496 21 CFR 113.40(e)(1) 1 Unreadable thermometer Mercury-in-glass thermometers were not installed where they can be accurately and easily read.  Specifically, ***
2499 21 CFR 113.40(e)(2) 1 Presence and accuracy Each retort did not have an accurate temperature-recording device.  Specifically, ***
2503 21 CFR 113.40(e)(2) 1 Unauthorized adjustment There was no means of preventing unauthorized changes in adjustment to the temperature-recording device.  Specifically, ***
2840 21 CFR 113.40(g)(1)(i)(a) 1 Calibration Thermometers and temperature indicating devices were not tested against a known accurate standard thermometer [upon installation] [at least once a year] [as frequently as necessary].  Specifically, ***
2846 21 CFR 113.40(g)(1)(i)(b) 1 Range Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of the processing temperature.  Specifically, ***
2856 21 CFR 113.40(g)(1)(i)(e) 1 Calibration The differential pressure recorder-controller was not tested [upon installation] [every three months of operation] [as frequently as necessary] against a known accurate standard pressure indicator.   Specifically, ***
2860 21 CFR 113.40(g)(1)(i)(f) 1 Unauthorized speed changes There was no means of preventing unauthorized speed changes to the metering pump.  Specifically, ***
2862 21 CFR 113.40(g)(1)(i)(g) 1 Heated or inadequate slope The product-sterilizing holding tube [was not designed to prevent heating of the tube between the product inlet and product outlet] [was not sloped upward at least 0.25 inch per foot].  Specifically, ***
2869 21 CFR 113.40(g)(1)(ii)(e) 1 Readings at start of aseptic processing Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic processing to ensure the values were as specified in the scheduled process for aseptic packaging operations.  Specifically, ***
2870 21 CFR 113.40(g)(1)(ii)(e) 1 Readings with sufficient frequency Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper performance of seam seals or similar devices] were not [performed]  [recorded] at intervals of sufficient frequency to ensure the values were as specified in the scheduled process for aseptic packaging operations.  Specifically ***
2885 21 CFR 113.40(i) 1 Methods and controls operated and administered for safety Methods and controls used for the manufacturing, processing and packaging of thermally processed foods wherein critical factors such as water activity are used are not operated and administered in a manner adequate to ensure the product is safe.  Specifically, ***
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, ***
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, ***
3092 21 CFR 114.89 1 Process deviation - disposition Failure to fully reprocess or destroy food where a process deviation has been evaluated as being unsafe. Specifically, ***
3648 21 CFR 110.20(a)(4) 1 Neighboring grounds Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control.  Specifically, ***
3710 21 CFR 110.80(b)(16) 1 Ice manufacturing Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality].  Specifically, ***
3869 21 CFR 113.60(a)(1)(ii) 1 Method of taking seam measurements (micrometer) Failure to measure can double seam characteristics using a  micrometer at three different points approximately 120 degrees apart, excluding the side seam.  Specifically, ***
3873 21 CFR 113.60(a)(3) 1 Records of closure examinations other than cans or glass Failure to maintain records of the results of inspections and tests performed on closing machines.  Specifically, ***
3887 21 CFR 113.89 1 Methods of process deviation evaluation Failure to use procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health in the evaluation of a deviation from the scheduled process.  Specifically, ***
3892 21 CFR 113.60(a) 1 Regular observations for gross closure defects Failure to make regular observations for gross closure defects during production runs.  Specifically ***
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, ***
4179 21 CFR 113.83 1 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, ***
4477 21 CFR 108.25(d) 1 Reporting to FDA Failure to promptly notify the FDA of any instance of [spoilage] [process deviation] [contamination with microorganisms] which represents a potential danger to public health, prior to distribution. 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, ***
4521 21 CFR 108.35(d) 1 Notify FDA - spoilage Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed. Specifically, ***
4522 21 CFR 108.35(e) 1 Notify FDA - contamination Failure to notify FDA about any instance of microbiological contamination, which may have caused  a lot to be injurious to health, when all or part of the lot was distributed. Specifically, ***
4523 21 CFR 108.35(f) 1 Recall procedures Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
4529 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, ***
9798 21 CFR 106.100(c) 1 Nutrient premix testing Failure to maintain all records pertaining to nutrient premix testing.  Specifically, ***
9917 21 CFR 120.10(c) 1 Corrective action documentation You do not have records that [fully] document corrective actions that were taken.  Specifically, ***
9953 21 CFR 120.11(a)(1)(iv)(A) 1 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, ***
9959 21 CFR 120.12(d)(1) 1 Record retention - general You do not retain [all of] the required records at your facility for the required time period.  Specifically, ***
12702 21 CFR 129.37(a) 1 Remedy unsanitary condition You did not remedy the presence of unsanitary conditions, scale, residue, or oxidation on a product water-contact surface by adequate cleaning and sanitizing prior to use.  Specifically, ***
12703 21 CFR 129.80(a) 1 Product samples You do not take product water samples after processing and prior to bottling.  Specifically, ***
12704 21 CFR 129.80(a) 1 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, ***
15001 21 CFR 113.60(a) 1 Corrective actions When a teardown examination revealed gross closure defects, [adequate] corrective action was not taken.  Specifically, ***
15351 FDCA 761(b)(1) 1 No AE report made (dietary supplement) No report was made of a serious adverse event associated with a dietary supplement marketed in the United States.  Specifically, ***
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, ***
15380 21 CFR 111.8 1 Written procedures - sick or infected personnel You did not [establish] [follow] written procedures for preventing microbial contamination from sick or infected personnel.  Specifically, ***
15381 21 CFR 111.8 1 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices.  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, ***
15390 21 CFR 111.10(b)(2) 1 Personnel cleanliness Your personnel did not maintain adequate cleanliness.  Specifically, ***
15391 21 CFR 111.10(b)(3) 1 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, ***
15392 21 CFR 111.10(b)(4) 1 Jewelry and objects - remove Your personnel did not remove unsecured [jewelry] [objects] that might fall into components, dietary supplements, equipment, or packaging.  Specifically, ***
15397 21 CFR 111.10(b)(7) 1 Personal belongings Your personnel stored clothing or other personal belongings in areas where [components, dietary supplements, or contact surfaces are exposed] [contact surfaces are washed].  Specifically, ***
15398 21 CFR 111.10(b)(8) 1 Food, gum, beverages, tobacco Your personnel [ate food] [chewed gum] [drank beverages] [used tobacco products] in areas where components, dietary supplements, or contact surfaces are exposed or where contact surfaces are washed.  Specifically, ***
15403 21 CFR 111.12(b) 1 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, ***
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, ***
15428 21 CFR 111.15(h) 1 Bathrooms - clean Your bathrooms [were not clean] [were a potential source of contamination to components, dietary supplements, or 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, ***
15432 21 CFR 111.15(e)(2) 1 Water supply - may be component - suitability Water that was used a manner such that the water may become a component of a dietary supplement did not comply with applicable [Federal] [State] [local] requirements.  Specifically, ***
15435 21 CFR 111.15(d)(3) 1 Insecticides, fungicides You used [insecticides] [fumigants] [fungicides] [rodenticides] without taking precautions to protect against the contamination of components, dietary supplements, or contact surfaces.  Specifically, ***
15445 21 CFR 111.15(c)(1) 1 Sanitizing agents You did not use sanitizing agents that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use].  Specifically, ***
15456 21 CFR 111.20(b) 1 Physical plant - space; equipment, materials Your physical plant did not have adequate space for the orderly placement of equipment and holding of materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination and mix-ups of components and dietary supplements].  Specifically, ***
15460 21 CFR 111.20(d)(1)(ii) 1 Physical plant - fixture Your [fixtures] [ducts] [pipes] were not designed and constructed so that they do not contaminate of components, dietary supplements, or contact surfaces by dripping,, leakage, or condensate.  Specifically, ***
15462 21 CFR 111.20(d)(1)(iv) 1 Physical plant - temperature, humidity controls Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement.  Specifically, ***
15466 21 CFR 111.20(c) 1 Physical plant - prevent mix-ups, contamination Your physical plant did not permit the use of proper precautions to reduce the potential for mix-ups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material.  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, ***
15475 21 CFR 111.20(e)(1) 1 Adequate light - processing, holding Your physical plant did not provide adequate light in areas where components or dietary supplements are [examined] [processed] [held].  Specifically, ***
15478 21 CFR 111.20(f) 1 Physical plant - bulbs, fixtures, skylights You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary supplements.  Specifically, ***
15486 21 CFR 111.23(a) 1 Records - physical plant - available You did not have records or copies of  records required for your physical plant and grounds readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, ***
15506 21 CFR 111.27(a)(4) 1 Equipment - bonded seams You used equipment or utensils that do not have seams that are smoothly bonded or maintained to minimize accumulation of extraneous materials or contaminants.  Specifically, ***
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, ***
15523 21 CFR 111.27(d)(7) 1 Utensils - store You did not store cleaned and sanitized utensils that are used to manufacture, package, label, or hold components or dietary supplements [in a manner] [in a location] that protects them from contamination.  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, ***
15528 21 CFR 111.30(d) 1 Equipment - automated - controls, process changes You did not [establish] [use] appropriate controls for automated, mechanical, or electronic equipment to ensure that changes [are approved by quality control personnel] [are instituted only by authorized personnel].  Specifically, ***
15535 21 CFR 111.255(d) 1 Batch record - 1 year, 2 years You did not keep batch production records for the required time period.  Specifically, ***
15540 21 CFR 111.260(a)(2)(i) 1 Batch record - control number, each lot Your batch production records did not include the batch, lot, or control number of each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement.  Specifically, ***
15553 21 CFR 111.260(j)(2)(i) 1 Batch record - initials; weighing Your batch production records did not include the initials of the person responsible for weighing or measuring each component used in the batch.  Specifically, ***
15555 21 CFR 111.260(j)(2)(iii) 1 Batch record - initials; component Your batch production records did not include the initials of the person responsible for adding a component to the batch.  Specifically, ***
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, ***
15563 21 CFR 111.260(l)(1)(i) 1 Batch record - quality control review; monitoring Your batch production records did not include documentation that quality control personnel reviewed required monitoring operations.  Specifically, ***
15568 21 CFR 111.260(m) 1 Batch record - performance Your batch production records did not include documentation [at the time of performance] of a required material review and disposition decision.  Specifically, ***
15571 21 CFR 111.153 1 Written procedures - packaging You did not [establish] [follow] written procedures for the requirements for packaging received.  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, ***
15576 21 CFR 111.155(a) 1 Visually examine - containers You did not visually examine each immediate container, or grouping of immediate containers in a shipment, for [appropriate content label] [container damage] [broken seals to determine whether the container condition may have resulted in contamination or deterioration of the components].  Specifically,  ***
15581 21 CFR 111.155(c)(3) 1 Quality control - components, approve, release Your quality control personnel did not [approve components while the components were quarantined] [release components from quarantine] for use in the manufacture of a dietary supplement.  Specifically, ***
15582 21 CFR 111.155(e) 1 Components - contamination, deterioration, mix-ups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  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, ***
15600 21 CFR 111.160(d)(2) 1 Packaging, labels - unique identifier, disposition You did not use a unique identifier whenever you recorded the disposition of each unique lot within each unique shipment of [packaging] [labels].  Specifically, ***
15602 21 CFR 111.160(e) 1 Packaging, labels - mix-ups You did not hold [packaging] [labels] under conditions that will avoid mix-ups.  Specifically, ***
15603 21 CFR 111.165(a) 1 Received product - visually examine container You did not visually examine each immediate container, or grouping of immediate containers, in a shipment of product that you received for packaging or labeling as a dietary supplement  for [appropriate content label] [container damage] [broken seals] to determine whether the container condition may have resulted in contamination or deterioration of the received product.  Specifically, ***
15604 21 CFR 111.165(b) 1 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© 1 Product received - quarantine You did not quarantine received product.  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, ***
15611 21 CFR 111.165(d)(2) 1 Product received - unique identifier, disposition You did not use a unique identifier when you recorded the disposition of a unique lot within a unique shipment of received product.  Specifically, ***
15615 21 CFR 111.180(a) 1 Records - components, packaging, labels, product received: You did not keep records required for [components] [packaging] [labels] [product received for packaging or labeling] for the required time period.  Specifically, ***
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,  ***
15625 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, ***
15708 21 CFR 111.325(a) 1 Written procedures, laboratory operations You did not make and keep written procedures for laboratory operations. Specifically, ***
15709 21 CFR 111.325(b)(2) 1 Laboratory methodology followed You did not make and keep documentation that established laboratory methodology was followed.  Specifically, ***
15712 21 CFR 111.325(b)(2)(ii) 1 Records - document; results The documentation for laboratory tests and examinations did not include the results of the testing and examination.  Specifically, ***
15721 21 CFR 111.365(k) 1 Processing lines, major equipment - contents You did not identify [processing lines] [major equipment] used during manufacturing to indicate their contents.  Specifically, ***
15722 21 CFR 111.365(j) 1 Containers - segregating, identifying You did not segregate and identify containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing.  Specifically, ***
15725 21 CFR 111.365(g) 1 Identifying, holding - contamination, mix-ups You did not identify and hold [components] [dietary supplements] for which a material review and disposition decision is required in a manner that protects [components] [dietary supplements] that are not under a material review against contamination and mix-ups with those that are under a material review.  Specifically, ***
15726 21 CFR 111.365(f) 1 Holding - prevent becoming adulterated You did not hold [components] [dietary supplements] that can support the rapid growth of microorganisms of public health significance in a manner that prevents them from becoming adulterated.  Specifically, ***
15727 21 CFR 111.365(e) 1 Microorganism, decomposition - remove, destroy, prevent You did not use effective means to [remove, destroy, or prevent the growth of microorganisms] [prevent decomposition]. 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, ***
15753 21 CFR 111.210(b) 1 Master manufacturing record - list components Your master manufacturing record did not include a complete list of components to be used.  Specifically, ***
15755 21 CFR 111.205(c) 1 Master manufacturing record:  readily available You did not have records or copies of records required for your master manufacturing records readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, ***
15756 21 CFR 111.205(c) 1 Master manufacturing record:  electronic Your electronic master manufacturing records do not comply with the electronic records requirements.  Specifically, ***
15758 21 CFR 111.205(c) 1 Master manufacturing record: 1 year, 2 years You did not keep a master manufacturing record for the required time period.  Specifically, ***
15765 21 CFR 111.430(a) 1 Packaging, labeling operations:originals, copies, electronic You did not keep the records required for your packaging and labeling operations as original records, true copies, or as electronic records.  Specifically, ***
15767 21 CFR 111.425 1 Quarantine - rejected packaged, labeled dietary supplement You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition packaged and labeled dietary supplement rejected for distribution.  Specifically, ***
15770 21 CFR 111.420(a) 1 Repackaging, relabeling - quality control, approve You [repackaged] [relabeled] a dietary supplement before approval by your quality control personnel Specifically, ***
15771 21 CFR 111.415(h) 1 Obsolete labels, packaging - dispose You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations.  Specifically, ***
15776 21 CFR 111.415(d) 1 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, ***
15778 21 CFR 111.415(b) 1 Dietary supplement - protect, contamination You did not protect manufactured dietary supplements from contamination during [filling] [assembling] [packaging] [labeling] operations.  Specifically, ***
15780 21 CFR 111.415 1 Fill, assemble, package, label - master record You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured that the dietary supplement is packaged and labeled as specified in the master manufacturing record.  Specifically, ***
15781 21 CFR 111.415 1 Fill, assemble, package, label - quality You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a way that ensured the quality of the dietary supplement.  Specifically, ***
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, ***
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, ***
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, ***
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, ***
15833 21 CFR 111.70(c)(1) 1 Specifications - in-process contamination limits You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically,  ***
15836 21 CFR 111.70(c)(3) 1 QC specification, identity, purity, strength, composition Your quality control personnel did not review and approve the 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, and composition of the dietary supplements.  Specifically, ***
15847 21 CFR 111.73 1 Specifications met - component identity You did not determine whether you met identity specifications established for components.  Specifically, ***
15848 21 CFR 111.73 1 Specifications met - component purity, strength, composition You did not determine whether you met established component specifications established to ensure the [purity] [strength] [composition] of dietary supplements manufactured using the components.  Specifically,  ***
15849 21 CFR 111.73 1 Specifications met - contamination limits You did not determine whether you met established limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.  Specifically, ***
15854 21 CFR 111.73 1 Specifications met - contamination limits You did not determine whether you met established limits on contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement.  Specifically, ***
15863 21 CFR 111.75(a)(2)(ii)(B) 1 Component - certificate of analysis The certificate of analysis for a component does not include [a description of the test or examination method(s) used] [limits of the test or examination] [actual results of the tests or examinations].  Specifically, ***
15868 21 CFR 111.75(b)(2) 1 Specifications met - deviation, unanticipated occurrence You did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated occurrence that may result in a failure to meet specifications.  Specifically, ***
15874 21 CFR 111.75(c)(4) 1 Documentation - specifications met; basis, quality control Your quality control personnel did not review and approve your documentation of the basis for determining compliance with [an] established specification[s] for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].  Specifically, ***
15875 21 CFR 111.75(d)(1) 1 Documentation specifications met; exempted, periodic testing You did not document why an exempted product specification is met without verification by periodically testing the finished batch.  Specifically, ***
15876 21 CFR 111.75(d)(2) 1 Exempted, periodic testing; quality control Your quality control personnel did not review and approve the documentation of why an exempted product specification is met without verification through periodic testing of the finished batch.  Specifically, ***
15881 21 CFR 111.75(g) 1 Packaging, labeling - visual examination You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label.  Specifically, ***
15890 21 CFR 111.80(a) 1 Components packaging, labels used You did not collect representative samples of each unique lot of [components] [packaging] [labels] that you used to determine whether the [components] [packaging] [labels] meet[s] established specifications.  Specifically, ***
15901 21 CFR 111.83(b)(3) 1 Reserve sample - retained You did not retain reserve samples for the required time.  Specifically, ***
15905 21 CFR 111.90(a)(1) 1 Reprocessed - rejected dietary supplement You reprocessed a rejected dietary supplement for which quality control personnel did not conduct a material review and make a disposition decision to approve the reprocessing.  Specifically, ***
15924 21 CFR 111.95(b)(5) 1 Documentation - exempted product specification met You did not make and keep documentation for why component and in-process testing, examination, monitoring or other information will ensure that an exempted product specification is met, without verification through periodic testing of the finished batch.  Specifically, ***
15933 21 CFR 111.105(b) 1 Quality control - supplier qualification Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers.  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, ***
15935 21 CFR 111.105(d) 1 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, ***
15938 21 CFR 111.105(f) 1 Quality control - representative samples Your quality control personnel did not ensure that required representative samples are collected.  Specifically, ***
15943 21 CFR 111.105(i) 1 QC required operations components packaging labels Your quality control personnel did not perform required operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically,  ***
15946 21 CFR 111.105(i) 1 QC - required operations returned dietary supplements Your quality control personnel did not perform required operations for returned dietary supplements. Specifically,  ***
15948 21 CFR 111.110 1 Quality control operations - laboratory operations You do not have quality control operations for laboratory operations associated with the production and process control system.  Specifically, ***
15958 21 CFR 111.113(a)(5) 1 QC returned dietary supplement; material review, disposition Your quality control personnel did not conduct a material review and make a disposition decision when a dietary supplement was returned.  Specifically, ***
15960 21 CFR 111.113(b)(1) 1 Quality control - dietary supplement; adulteration Your quality control personnel did not reject the dietary supplement when there was a deviation or unanticipated occurrence during the production and in-process control system that [resulted in] [could lead to] adulteration of the dietary supplement.  Specifically, ***
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, ***
15968 21 CFR 111.117(c) 1 Quality control operations - equipment records Your quality control operations did not include periodically reviewing all records for calibrations, inspections, or checks of [automated equipment] [mechanical equipment] [electronic equipment].  Specifically, ***
15969 21 CFR 111.117(d) 1 Quality control operations - equipment functions Your quality control operations did not include reviewing and approving controls to ensure that [automated] [mechanical] [electronic] equipment functions according to [its] [their] intended use.  Specifically, ***
15970 21 CFR 111.120 1 Quality control operations - components, packaging, labels You do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement.  Specifically, ***
15978 21 CFR 111.123(a)(2) 1 Quality control operations - batch production records Your quality control operations did not include reviewing and approving all batch production-related records.  Specifically, ***
15980 21 CFR 111.123(a)(4) 1 QC operations - material review, disposition decision Your quality control operations for [the master manufacturing record] [the batch production record] [manufacturing operations] did not include conducting a required material review and making a required disposition decision.  Specifically, ***
15981 21 CFR 111.123(a)(5) 1 Quality control operations - reprocessing Your quality control operations did not include approving or rejecting reprocessing.  Specifically, ***
15985 21 CFR 111.123(b)(1) 1 Quality control - components, identity specifications Your quality control personnel approved and released for distribution a batch of dietary supplement for which one or more components did not meet identity specifications.  Specifically, ***
15987 21 CFR 111.123(b)(3) 1 Quality control - batch released, adulteration Your quality control personnel approved and released for distribution a batch of dietary supplement that was not manufactured, packaged, labeled, or held under conditions to prevent adulteration.  Specifically, ***
15988 21 CFR 111.123(b)(4) 1 QC supplier; product released, assurance not provided label Your quality control personnel approved and released for distribution product received from a supplier for [labeling] as a dietary supplement for which sufficient assurance was not provided [to adequately identify the product] [to determine that the product was consistent with your purchase order].  Specifically, ***
16006 21 CFR 111.130(d) 1 QC operations - returned dietary supplement; specifications Your quality control operations for returned dietary supplements did not include [determining whether a reprocessed dietary supplement meets product specifications] [either approving for release, or rejecting, any returned dietary supplement that was reprocessed].  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, ***
16010 21 CFR 111.140(a) 1 Records - QC operations:  originals, copies, electronic You did not keep the records required for your quality control operations as original records, true copies, or as electronic records.  Specifically, ***
16011 21 CFR 111.140(a) 1 Records - quality control operations:  electronic Your electronic records for your quality control operations do not comply with the electronic records requirements.  Specifically,  ***
16017 21 CFR 111.140(b)(3) 1 Records - material review, disposition You did not make and keep documentation of your material review and disposition decision. Specifically, ***
16043 21 CFR 111.503 1 Written procedures - returned dietary supplement; destroyed You did not [establish] [follow] written procedures for when a returned dietary supplement must be destroyed, or otherwise suitably disposed.  Specifically, ***
16051 21 CFR 111.525(b) 1 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, ***
16061 21 CFR 111.35(a) 1 Records -  equipment, utensils: 1 year, 2 years You did not keep the records required for equipment and utensils for the required time period.  Specifically, ***
16069 21 CFR 111.35(b)(1)(iii) 1 Procedures contact surfaces; maintaining, cleaning, sanitize You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.  Specifically, ***
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, ***
16077 21 CFR 111.35(b)(5) 1 Records - backup files, outdated software You did not make and keep backup files of outdated software necessary to retrieve records from the computer systems that you use to manufacture, package, label, or hold dietary supplements.  Specifically, ***
16119 21 CFR 118.4(a)(1) 1 Procurement of chicks You do not procure chicks from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for "U.S. S. Enteritidis Clean" or equivalent status.  Specifically,***
16150 21 CFR 118.4(e) 1 Eggs to be processed as table eggs Eggs intended to be processed as table eggs [were not held and transported as required at or below 45 deg. F] [were held at room temperature for more than 36 hours just prior to processing].  Specifically,***
16153 21 CFR 118.5(a)(1) 1 Poultry house has multiple groups of laying hens Environmental testing for SE, using approved methods,  was not done in a poultry house containing more than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age.  Specifically,***
16168 21 CFR 118.6(f) 1 Labeling on diverted eggs For eggs being diverted to treatment, the statement "Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f)" fails to appear [on the pallet, case or other shipping container] [on all documents accompanying the shipment] [in a legible and conspicuous manner].  Specifically,***
16171 21 CFR 118.7(a) 1 Environmental test An environmental test for SE was not done for each poultry house as required.  Specifically,***
16184 21 CFR 118.9 1 Lack of supervisory personnel You do not have one or more supervisory personnel who are responsible for ensuring compliance with each farm's SE prevention plan.  Specifically,***
16185 21 CFR 118.9 1 Supervisor duties You lack [qualified] supervisory personnel who are responsible for [development and implementation of an SE plan that is appropriate for your farm and meets the regulatory requirement] [reassessing and modifying the SE prevention plan as necessary] [reviewing records created to document the SE prevention measures].  Specifically, ***
16197 21 CFR 118.10(a)(3)(vi) 1 SE testing results documentation You did not maintain records documenting the results of SE testing.  Specifically,***
16200 21 CFR 118.10(d) 1 Offsite storage of records except SE plan Your written SE prevention plan was stored offsite.  Specifically,***
16209 21 CFR 118.11(a) 1 Registration within 30 days Your firm did not register your farm(s) with the FDA [within 30 days of becoming an egg producer] [by the applicable effective date of the regulation (21 CFR Part 118)].  Specifically,***
17004 FDCA 402(a) 1 Food Field Exam During a field examination of food products at your facility the following [was] [were] observed:

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Devices

Center Name Cite Id Ref No Frequency Short Description Long Description
Devices 3130 21 CFR 820.100(a) 378 Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
14713 21 CFR 820.198(a) 245 Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,***
3696 21 CFR 820.100(b) 133 Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***
546 21 CFR 820.75(a) 127 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, ***
630 21 CFR 803.17 124 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, ***
479 21 CFR 820.50 110 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, ***
3282 21 CFR 820.90(a) 98 Nonconforming product,  Lack of or inadequate procedures Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, ***
3103 21 CFR 820.30(i) 93 Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,***
3331 21 CFR 820.181 77 DMR - not or inadequately maintained A device master record has not been [adequately] maintained.  Specifically, ***
2327 21 CFR 820.22 73 Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been [adequately] established. Specifically, ***
14712 21 CFR 820.184 72 DHR - not or inadequately maintained A device history record has not been [adequately] maintained.  Specifically, ***
3125 21 CFR 820.80(d) 70 Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
3172 21 CFR 820.198(c) 69 Investigation of device failures Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
2350 21 CFR 820.25(b) 61 Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***
3101 21 CFR 820.30(g) 61 Design validation- Lack of or inadequate procedures Procedures for design validation have not been [adequately] established.  Specifically,***
3168 21 CFR 820.198(a) 58 Complaints Complaint files are not [adequately] maintained.  Specifically ***
14722 21 CFR 820.40 58 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,***
3666 21 CFR 820.20(c) 57 Management review - Lack of or inadequate procedures Procedures for management review have not been [adequately] established.  Specifically,***
2371 21 CFR 820.30(a) 55 Design control - no procedures Procedures for design control have not been established.  Specifically,***
3680 21 CFR 820.70(a) 54 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, ***
3160 21 CFR 820.184 53 Lack of or inadequate DHR procedures Procedures for device history records have not been [adequately] established.  Specifically,***
3678 21 CFR 820.30(g) 52 Design Validation - Risk analysis not performed/inadequate Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***
3159 21 CFR 820.184 51 DHR content The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
3233 21 CFR 820.72(a) 51 Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, ***
3121 21 CFR 820.80(b) 46 Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
541 21 CFR 820.70(c) 45 Environmental control  Lack of or inadequate procedures Procedures to control environmental conditions have not been [adequately] established.  Specifically, ***
732 21 CFR 803.50(a)(2) 43 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, ***
3120 21 CFR 820.80(a) 41 Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,***
3415 21 CFR 820.22 41 Quality Audit/Reaudit - conducted Quality [audits][reaudits] have not been performed.  Specifically, ***
3118 21 CFR 820.75(a) 39 Documentation Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, ***
3127 21 CFR 820.80(e) 38 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, ***
3375 21 CFR 820.198(e) 38 Records of complaint investigation Records of complaint investigations do not include required information.  Specifically, ***
447 21 CFR 820.40 37 Lack of procedures, or not maintained Document control procedures have not been [established] [maintained].  Specifically,***
2650 21 CFR 820.30(f) 37 Design verification - Lack of or inadequate procedures Procedures for design verification 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].
3128 21 CFR 820.90(a) 36 Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, ***
4059 21 CFR 820.22 36 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, ***
2328 21 CFR 820.22 35 Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
3669 21 CFR 820.20(c) 35 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, ***
539 21 CFR 820.70(b) 32 Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, ***
419 21 CFR 820.20(b) 30 Lack of or inadequate organizational structure The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820.  Specifically, ***
537 21 CFR 820.70(a) 30 Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, ***
3427 21 CFR 820.50(a)(2) 29 Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
2604 21 CFR 820.30(e) 28 Design review - Lack of or inadequate procedures Procedures for design review have not been [adequately] established.  Specifically,***
3117 21 CFR 820.70(i) 28 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, ***
3837 21 CFR 820.25(b) 28 Training records Personnel training is not documented. Specifically, ***
486 21 CFR 820.50(a) 26 Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   Specifically, ***
731 21 CFR 803.50(a)(1) 26 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, ***
2968 21 CFR 812.100 26 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, ***
2974 21 CFR 812.110(b) 26 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, ***
3123 21 CFR 820.80(c) 25 Lack of or inadequate In-process acceptance procedures Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
3132 21 CFR 820.120 24 Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been [adequately] established. Specifically, ***
3426 21 CFR 820.50(a)(1) 24 Documented evaluation The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***
14716 21 CFR 820.30(f) 24 Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, ***
14720 21 CFR 820.50(a)(3) 23 Acceptable supplier records, inadequate records Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
3345 21 CFR 820.200(a) 22 Servicing - Lack of or inadequate procedures Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
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, ***
2302 21 CFR 820.20(e) 21 Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,***
3285 21 CFR 820.90(b)(2) 21 Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, ***
631 21 CFR 803.17(a)(1) 20 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, ***
2430 21 CFR 820.30(b) 20 Design plans - Lack of or  inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
2557 21 CFR 820.30(c) 20 Design input - documentation Design input requirements were not [adequately] documented.   Specifically, ***
3286 21 CFR 820.90(b)(1) 20 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, ***
14710 21 CFR 820.150 20 Lack of or inadequate procedures for storage. Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,***
3102 21 CFR 820.30(h) 19 Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been [adequately] established.  Specifically,***
3170 21 CFR 820.198(b) 18 Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
3263 21 CFR 820.250(b) 18 Sampling plans Sampling plans are not [written][based on valid statistical rationale].  Specifically, ***
3201 21 CFR 820.40(a) 17 Not approved or obsolete document retrieval Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
14505 21 CFR 812.140(a)(3) 16 Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, ***
3119 21 CFR 820.75(b) 15 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, ***
3226 21 CFR 820.70(g)(1) 15 Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, ***
3269 21 CFR 820.80(b) 15 Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented. Specifically, ***
632 21 CFR 803.17(a)(2) 14 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, ***
3108 21 CFR 820.70(e) 14 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, ***
3207 21 CFR 820.50(b) 14 Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, ***
3671 21 CFR 820.25(a) 14 Personnel Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
3262 21 CFR 820.250(a) 13 Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been [adequately] established.  Specifically,***
3266 21 CFR 820.86 13 Acceptance status The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, ***
3433 21 CFR 820.75(c) 13 Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
4070 21 CFR 820.30(g) 13 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, ***
14714 21 CFR 820.30(c) 13 Design input - Lack of or inadequate procedures Procedures for design input have not been [adequately] established.  Specifically,***
3676 21 CFR 820.30(f) 12 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, ***
454 21 CFR 820.40(a) 11 Document review, approval by designated individual Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, ***
2984 21 CFR 812.140(a)(3)(i) 11 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, ***
3313 21 CFR 820.120(d) 11 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, ***
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, ***
3432 21 CFR 820.75(b)(2) 11 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, ***
4189 21 CFR 820.198(a) 11 General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].  Specifically, ***
14711 21 CFR 820.160(a) 11 Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,***
2293 21 CFR 820.20(d) 10 Quality plan A quality plan has not been [adequately] established.  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 ***
3191 21 CFR 820.30(g) 10 Design validation - production units The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***
3192 21 CFR 820.30(g) 10 Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, ***
3199 21 CFR 820.40(a) 10 Document review, approval documentation The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, ***
3204 21 CFR 820.40(b) 10 Change records, content Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective].  Specifically, ***
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, ***
3235 21 CFR 820.72(a) 10 Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.  Specifically, ***
3270 21 CFR 820.80(c) 10 Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3683 21 CFR 820.70(g) 10 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, ***
14715 21 CFR 820.30(d) 10 Design output - Lack of or inadequate procedures Procedures for design output have not been [adequately] established.  Specifically,***
812 21 CFR 803.56 9 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, ***
2269 21 CFR 820.20(a) 9 Quality policy and objectives The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility.  Specifically, ***
2630 21 CFR 820.30(e) 9 Design review - documentation The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file.  Specifically, ***
2981 21 CFR 812.140(a)(2)(i) 9 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, ***
3264 21 CFR 820.250(b) 9 Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,***
3668 21 CFR 820.20(c) 9 Management review dates The results and/or dates of management reviews are not documented. Specifically, ***
4212 21 CFR 806.20(b)(4) 9 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,***
502 21 CFR 820.60 8 Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established.  Specifically, ***
633 21 CFR 803.17(a)(3) 8 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, ***
2970 21 CFR 812.100 8 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
3173 21 CFR 820.198(d) 8 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, ***
3203 21 CFR 820.40(b) 8 Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, ***
3206 21 CFR 820.50(b) 8 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, ***
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, ***
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, ***
3686 21 CFR 820.90(b)(2) 8 Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, ***
14507 21 CFR 812.140(a)(3)(ii) 8 Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].  Specifically, ***
14718 21 CFR 820.30(g) 8 Design validation - Risk analysis Results of the design risk analysis were not [adequately] documented.  Specifically, ***
14719 21 CFR 820.30(h) 8 Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***
636 21 CFR 803.17(b)(2) 7 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, ***
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, ***
3190 21 CFR 820.30(g) 7 Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, ***
3237 21 CFR 820.72(b) 7 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, ***
3310 21 CFR 820.120(b) 7 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, ***
3409 21 CFR 820.200(d) 7 Service reports Service reports [are not documented] [do not include the required information].  Specifically, ***
4057 21 CFR 820.20(a) 7 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, ***
635 21 CFR 803.17(b)(1) 6 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, ***
3138 21 CFR 820.130 6 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, ***
3147 21 CFR 820.170(a) 6 Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,***
3236 21 CFR 820.72(b) 6 Calibration procedures - content Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, ***
14717 21 CFR 820.30(g) 6 Design validation - software validation documentation Results of the validation of the device software were not [adequately] documented.  Specifically, ***
733 21 CFR 803.50(b)(1) 5 Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, ***
3346 21 CFR 820.200(b) 5 Analyzing service report Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3434 21 CFR 820.75(c) 5 Documentation - review in response to changes or deviations There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations.  Specifically, ***
3674 21 CFR 820.30(d) 5 Design output - documentation Design output was not [adequately] documented before release.  Specifically, ***
3841 21 CFR 820.90(b)(2) 5 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, ***
2431 21 CFR 820.30(b) 4 Design plans- updated Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***
2648 21 CFR 820.30(f) 4 Design verification procedures Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2985 21 CFR 812.140(a)(3)(ii) 4 Investigator records of relevant observations inadequate Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the investigation] [all diagnostic test results] are not all [accurate] [complete] [current].  Specifically, ***
2994 21 CFR 812.140(b)(3) 4 Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
3064 21 CFR 812.140(a)(4) 4 Investigator protocol records inadequate Copies maintained of the study protocol are not all [accurate] [complete] [current].  Specifically, ***
3109 21 CFR 820.70(d) 4 Personnel requirements, Lack of or inadequate requirements Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing].  Specifically, ***
3155 21 CFR 820.181(a) 4 DMR device specifications The device master record does not include or refer to the location of  device software specifications.  Specifically, ***
3239 21 CFR 820.72(b) 4 Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3309 21 CFR 820.120(b) 4 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, ***
3372 21 CFR 820.198(d) 4 Records of MDR Investigation Investigation records of MDR reportable complaints do not include required information.  Specifically ***
4192 21 CFR 806.10(a)(2) 4 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, ***
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, ***
2339 21 CFR 820.22 3 Quality Audit/Reaudit - documentation The dates of quality [audits][reaudits] have not been documented.  Specifically, ***
2628 21 CFR 820.30(e) 3 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, ***
2910 21 CFR 812.7(a) 3 Promotion or test marketing An investigational device was [promoted] [test marketed] prior to FDA approval/clearance.  Specifically, ***
2928 21 CFR 812.40 3 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, ***
2980 21 CFR 812.140(a)(1) 3 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, ***
3007 21 CFR 812.140(d) 3 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, ***
3111 21 CFR 820.70(f) 3 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, ***
3113 21 CFR 820.70(g) 3 Equipment design and installation Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
3115 21 CFR 820.70(h) 3 Use and removal, Lack of or inadequate procedures Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, ***
3175 21 CFR 820.186 3 QSR The quality system record has not been [adequately] maintained   Specifically ***
3328 21 CFR 820.180(b) 3 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, ***
3332 21 CFR 820.184(e) 3 ID label, labeling The device history record does not include the primary identification label and labeling for each device.  Specifically, ***
14511 21 CFR 812.2(b) 3 Abbreviated requirements / non-significant risk study A clinical investigation that was determined to be a non-significant risk device study does not meet the abbreviated requirements for investigational device exemptions (IDEs).  Specifically, ***
14523 21 CFR 812.43(c) 3 No investigator agreement A signed investigator agreement was not obtained from each participating investigator .  Specifically,***
538 21 CFR 820.70(a) 2 Process control procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented].  Specifically, ***
2338 21 CFR 820.22 2 Quality audit - audit report review Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited.   Specifically, ***
2602 21 CFR 820.30(d) 2 Design output - review and approval Design output was not [reviewed] [approved] before release.  Specifically, ***
2969 21 CFR 812.100 2 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.  Specifically, ***
2973 21 CFR 812.110(a) 2 Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
2983 21 CFR 812.140(a)(2)(iii) 2 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, ***
2993 21 CFR 812.140(b)(2) 2 Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current].  Specifically, ***
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, ***
3048 21 CFR 812.150(b)(5) 2 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) 2 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, ***
3065 21 CFR 812.140(a)(5) 2 Additional investigator records FDA requires Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, ***
3193 21 CFR 820.30(g) 2 Design validation - simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***
3198 21 CFR 820.40(b) 2 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) 2 Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, ***
3291 21 CFR 820.100(b) 2 Procedures The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3323 21 CFR 820.170(b) 2 Installer records The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.
3343 21 CFR 820.198(e) 2 Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3672 21 CFR 820.30(c) 2 Design input - review and approval Design input requirements were not [reviewed] [approved] by designated individual(s).  Specifically, ***
3692 21 CFR 820.100(a)(4) 2 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, ***
7017 21 CFR 812.150(b)(7) 2 Sponsor final report for non-significant risk study For an investigation subject to the abbreviated requirements, a final report was not submitted to all reviewing IRBs [within six months] after [termination] [completion] of an investigational device study.  Specifically, **
621 21 CFR 803.11 1 Failure to use FDA Form 3500A An MDR adverse event report was submitted on a form other than FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent.  Specifically, ***
638 21 CFR 803.17(b)(4) 1 Info which facilitates timely FDA follow-up The written MDR procedure does not include documentation and recordkeeping requirements for systems that ensure access to information that facilitates timely follow-up and inspection by FDA.  Specifically, ***
640 21 CFR 803.18(a) 1 Event files--failure to establish MDR event files have not been established and maintained.  Specifically, ***
642 21 CFR 803.18(b)(1)(i) 1 Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.  Specifically, ***
648 21 CFR 803.18(e) 1 MDR not  evaluated per 820.162 and 820.198 A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding [Failure Investigations] [Complaint Files].  Specifically, ***
649 21 CFR 803.18(e) 1 Info not obtained or submitted MDR files do not contain explanations of why required information [was not submitted] [could not be obtained].  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, ***
735 21 CFR 803.50(b)(2) 1 Explanation of Incomplete Information An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information.  Specifically, ***
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, ***
793 21 CFR 803.53(a) 1 Firm Did Not Submit 5 Day Report A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.  Specifically, ***
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, ***
2923 21 CFR 812.20(a)(1) 1 Did not submit IDE application to FDA An application was not submitted to FDA when [a significant risk device investigation was to be undertaken] [an investigation that involves exception from informed consent was intended] [FDA sent notification that an application was required for an investigation].  Specifically, ***
2930 21 CFR 812.42 1 Sponsor began study before IRB/FDA approval [An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***
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, ***
2966 21 CFR 812.66 1 No IRB notification of significant risk determination The reviewing IRB did not notify [the investigator] [the sponsor] after determining that a device study, presented for approval as a non-significant risk device study, was actually a significant risk device study.  Specifically, ***
2991 21 CFR 812.140(b)(1) 1 Sponsor correspondence records inadequate Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current].  Specifically, ***
2995 21 CFR 812.140(b)(4) 1 Availability of records of non-significant risk studies For an investigation subject to the abbreviated requirements, records are not [consolidated in one location] [available for FDA inspection and copying].  Specifically, ***
2996 21 CFR 812.140(b)(4)(i) 1 Sponsor records re device use in non-significant risk study For an investigation subject to the abbreviated requirements, records which include the [name and intended use of the device] [objectives of the investigation] are not all [accurate] [complete] [current].  Specifically, ***
2999 21 CFR 812.140(b)(4)(iv) 1 Sponsor records of non-significant risk study IRBs For an investigation subject to the abbreviated requirements, records that include the name and address of each IRB that has reviewed the investigation are not all [accurate] [complete] [current].  Specifically, ***
3000 21 CFR 812.140(b)(4)(v) 1 Sponsor records re QSR/GMP & non-significant risk studies For an investigation subject to the abbreviated requirements, records that include a statement of the extent to which the regulations covering current good manufacturing practice would be followed in manufacturing the device reports are not all [accurate] [complete] [current]. Specifically, ***
3001 21 CFR 812.140(b)(4)(vi) 1 Sponsor lack of other FDA-required info For an investigation subject to the abbreviated requirements, records that include additional information required by FDA 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, ***
3021 21 CFR 812.150(a)(1) 1 Investigator report of unanticipated adverse effects A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].  Specifically, ***
3025 21 CFR 812.150(a)(3) 1 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, ***
3028 21 CFR 812.150(a)(4) 1 No approval for investigator change in non-emergency Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation.  Specifically, ***
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, ***
3038 21 CFR 812.150(b)(1) 1 Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within 10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating investigators].  Specifically, ***
3052 21 CFR 812.150(b)(6) 1 Sponsor notif. of rqst. to return/repair/dispose not made Notification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device.  Specifically, ***
3054 21 CFR 812.150(b)(7) 1 30-day sponsor notification to FDA FDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk device study.  Specifically, ***
3156 21 CFR 820.181(b) 1 DMR production process specifications The device master record does not include or refer to the location of [all] production and process specifications.  Specifically, ***
3167 21 CFR 820.198(a) 1 Complete files maintained Complete complaint files are not maintained.  Specifically, ***
3208 21 CFR 820.50(b) 1 Approval of purchasing data {see also 820.40(a)} The purchasing data were not approved.  Specifically, ***
3210 21 CFR 820.65 1 Documentation of control numbers {see also 820.184} Control numbers for [implantable or life supporting devices] [appropriate components] were not documented in the device history record.  Specifically, ***
3283 21 CFR 820.90(a) 1 Specific non-conforming product procedures Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete].  Specifically, ***
3347 21 CFR 820.200(c) 1 Service reports/MDRs/complaints Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
3355 21 CFR 820.198(f) 1 Records accessibility Investigated complaints and records of investigation were not accessible to the manufacturing establishment.  Specifically, ***
3371 21 CFR 820.198(a)(3) 1 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, ***
3378 21 CFR 820.198(e)(4) 1 Complainant data Records of complaint investigations do not include the [name] [address] [phone number] of the complainant.  Specifically, ***
3383 21 CFR 820.198(g) 1 Foreign complaint files The manufacturer's formally designated complaint unit is located outside of the United States and complaint records are not reasonably accessible in the United States.  Specifically, ***
3414 21 CFR 820.200(d)(6) 1 Test and inspection data Service reports do not include applicable test and/or inspection data.  Specifically, ***
3417 21 CFR 820.70(a)(2) 1 Production monitoring and control During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled.  Specifically, ***
3682 21 CFR 820.70(d) 1 Implementing Personnel Procedures, Health, Cleanliness. Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, ***
3688 21 CFR 820.100(a)(1) 1 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, ***
4201 21 CFR 806.10(c)(8) 1 Illness report Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not been reported.  Specifically,***
4202 21 CFR 806.10(c)(9) 1 Device number, identification The [total number] [sub-lot identification] of devices subject to correction or removal actions was not reported.  Specifically,***
4204 21 CFR 806.10(c)(11) 1 Domestic & foreign consignees The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject to correction or removal actions and number of devices distributed to each consignee were not reported.  Specifically,***
4207 21 CFR 806.10(d) 1 Notification of extended action No amended notification with required information was submitted within 10 working days of initiating an extension of the correction or removal action.  Specifically,***
4208 21 CFR 806.20(a) 1 Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,***
4210 21 CFR 806.20(b)(2) 1 Device model identification The records of devices subject to correction and removal actions did not contain the [model] [catalog] [code number] of the device and the manufacturing [lot] [serial number] [identifying number] of the device.  Specifically,***
4227 21 CFR 821.20(a) 1 Failure to track Devices identified in an FDA tracking order were not tracked in accordance with tracking procedures.  Specifically, ***
4252 21 CFR 821.25(c)(3) 1 Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling [has not been established] [is not complete] [has not been followed].  Specifically,***
4278 21 CFR 821.50(a) 1 Not available for inspection All device tracking records and all tracking information were not available for inspection.  Specifically,***
4430 21 CFR 803.18(d)(1) 1 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, ***
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, ***
7006 21 CFR 812.43(c)(5) 1 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, ***
7012 21 CFR 812.100 1 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, ***
14508 21 CFR 812.140(a)(4) 1 Investigator record of protocol deviations inadequate Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current].  Specifically,***
14513 21 CFR 812.2(c)(3) 1 Needs IDE; diagnostic device exemption conditions not met An investigation requires an IDE, in that the device is a diagnostic device which [is invasive] [requires an invasive sampling procedure that presents significant risk] [by design or intention introduces energy into a subject] [is used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure].  Specifically, ***
14520 21 CFR 812.36(d) 1 No FDA approval for treatment IDE A treatment IDE did not have FDA approval.  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, ***

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Drugs

Center Name Cite Id Ref No Frequency Short Description Long Description
Drugs 1105 21 CFR 211.22(d) 155 Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, ***
2027 21 CFR 211.192 131 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, ***
1361 21 CFR 211.100(a) 106 Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  Specifically, ***
3603 21 CFR 211.160(b) 99 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, ***
1215 21 CFR 211.67(b) 77 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, ***
1451 21 CFR 211.113(b) 76 Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, ***
1213 21 CFR 211.67(a) 71 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) 66 Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.  Specifically, ***
3585 21 CFR 211.110(a) 65 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, ***
1914 21 CFR 211.166(a) 62 Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, ***
1358 21 CFR 211.100(b) 59 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, ***
1274 21 CFR 211.68(a) 56 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 56 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, ***
4314 21 CFR 211.84(d)(2) 53 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, ***
1177 21 CFR 211.63 49 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, ***
1112 21 CFR 211.25(a) 44 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, ***
2419 21 CFR 211.198(a) 44 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, ***
1452 21 CFR 211.113(b) 43 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, ***
1890 21 CFR 211.165(e) 39 Test methods The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, ***
1111 21 CFR 211.25(a) 38 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, ***
1133 21 CFR 211.25(a) 36 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, ***
1809 21 CFR 211.160(a) 34 Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, ***
1943 21 CFR 211.180(e)(1) 34 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, ***
4402 21 CFR 211.192 32 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, ***
1159 21 CFR 211.28(a) 31 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, ***
1434 21 CFR 211.42(c)(10)(iv) 31 Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***
1810 21 CFR 211.160(a) 29 Lab controls established, including changes The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***
1767 21 CFR 211.137(a) 28 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, ***
2026 21 CFR 211.192 28 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, ***
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, ***
1891 21 CFR 211.165(f) 27 Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, ***
1885 21 CFR 211.165(b) 26 Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, ***
2028 21 CFR 211.192 26 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) 26 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, , ***
3632 21 CFR 211.170(b) 26 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, ***
4303 21 CFR 211.67 b) 26 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, ***
4342 21 CFR 211.142(b) 26 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, ***
4352 21 CFR 211.160(b)(4) 26 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, ***
9001 21 CFR 211.22(a) 26 Lack of quality control unit There is no quality control unit.  Specifically, ***
1450 21 CFR 211.113(a) 25 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, ***
1787 21 CFR 211.80(a) 25 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, ***
3572 21 CFR 211.100(b) 25 Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, ***
1448 21 CFR 211.111 24 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, ***
4391 21 CFR 211.180(e)(2) 23 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, ***
4576 21 CFR 211.192 22 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, ***
1920 21 CFR 211.166a)(3) 21 Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, ***
1435 21 CFR 211.42(c)(10)(v) 20 Cleaning System Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***
1833 21 CFR 211.84(d)(1) 20 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, ***
3559 21 CFR 211.56(a) 20 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, ***
1926 21 CFR 211.166(b) 18 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, ***
1975 21 CFR 211.182 18 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  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, ***
3565 21 CFR 211.58 18 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, ***
1033 21 CFR 211.22(a) 17 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, ***
1263 21 CFR 211.68(b) 17 Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.  Specifically, ***
1912 21 CFR 211.166(a) 17 Written program not followed The written stability testing program is not followed.  Specifically, ***
3571 21 CFR 211.100(a) 17 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, ***
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, ***
4413 21 CFR 211.194(a)(8) 17 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, ***
1098 21 CFR 211.22(c) 16 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, ***
1550 21 CFR 211.125(f) 16 Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
6732 21 CFR 314.80(c)(1)(i) 16 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, ***
1194 21 CFR 211.42(c) 15 Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
1932 21 CFR 211.167(a) 15 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, ***
2008 21 CFR 211.186(a) 15 Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***
2619 21 CFR 211.198(b)(2) 15 Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, ***
3561 21 CFR 211.56(b) 15 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, ***
8907 21 CFR 314.81(b)(1)(ii) 15 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, ***
1162 21 CFR 211.28(a) 14 Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, ***
1540 21 CFR 211.125(a) 14 Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, ***
4340 21 CFR 211.142 14 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, ***
4372 21 CFR 211.188(b)(8) 14 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, ***
1261 21 CFR 211.68(a) 13 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, ***
2205 21 CFR 211.186(b)(9) 13 Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions].  Specifically, ***
3616 21 CFR 211.165(d) 13 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, ***
3629 21 CFR 211.170(b) 13 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, ***
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, ***
17764 21 CFR 212.20(e) 13 Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,***
1086 21 CFR 211.22(b) 12 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, ***
1227 21 CFR 211.67(c) 12 Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, ***
1433 21 CFR 211.42(c)(10)(iii) 12 Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, ***
1942 21 CFR 211.180(e) 12 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) 12 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, ***
4336 21 CFR 211.150 12 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, ***
4357 21 CFR 211.166(a) 12 Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, ***
6730 21 CFR 314.80(b) 12 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, ***
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, ***
17812 21 CFR 212.50 12 Adequate controls (general) Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.  Specifically,***
1169 21 CFR 211.42(a) 11 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, ***
1395 21 CFR 211.103 11 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, ***
1802 21 CFR 211.84(b) 11 Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, ***
3570 21 CFR 211.100(a) 11 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, ***
3583 21 CFR 211.110(a) 11 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, ***
1626 21 CFR 211.130 10 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, ***
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, ***
1270 21 CFR 211.68(b) 9 input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  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, ***
1790 21 CFR 211.80(b) 9 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) 9 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, ***
4317 21 CFR 211.84(d)(3) 9 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, ***
4406 21 CFR 211.194(a)(2) 9 Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.  Specifically, ***
1134 21 CFR 211.25(b) 8 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, ***
1136 21 CFR 211.25(c) 8 Inadequate number of  personnel The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
4338 21 CFR 211.150(b) 8 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, ***
1421 21 CFR 211.42(c)(10) 7 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,***
1454 21 CFR 211.115(a) 7 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, ***
1869 21 CFR 211.94(c) 7 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, ***
3591 21 CFR 211.110(b) 7 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, ***
3613 21 CFR 211.160(b)(4) 7 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, ***
4306 21 CFR 211.80(a) 7 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, ***
4315 21 CFR 211.84(d)(2) 7 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, ***
17763 21 CFR 212.20(d) 7 Determination need for investigation When errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,***
1163 21 CFR 211.28(b) 6 Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits.  Specifically, ***
1844 21 CFR 211.84(d)(2) 6 Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1879 21 CFR 211.180(c) 6 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, ***
2012 21 CFR 211.188(b) 6 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, ***
4320 21 CFR 211.84(d)(6) 6 Microbiological Contamination Exam Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.  Specifically, ***
4324 21 CFR 211.110(b) 6 In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, ***
4351 21 CFR 211.160(b)(3) 6 Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, ***
4359 21 CFR 211.170(a)(1), (b)(1) 6 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.
4377 21 CFR 211.188(b(3) 6 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, ***
6823 21 CFR 314.80(c) 6 Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA.  Specifically, ***
17749 21 CFR 212.30(a) 6 Prevention of contamination Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by [substances] [personnel] [environmental conditions] that could reasonably be expected to have an adverse effect on product quality.  Specifically,***
1266 21 CFR 211.42(d) 5 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,  ***
1495 21 CFR 211.122(a) 5 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, ***
1632 21 CFR 211.130(c) 5 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, ***
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, ***
1803 21 CFR 211.84(b) 5 Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.  Specifically, ***
1886 21 CFR 211.165(c) 5 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, ***
1918 21 CFR 211.166(a)(2) 5 Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, ***
1976 21 CFR 211.182 5 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, ***
2044 21 CFR 211.196 5 Distribution Record Requirements Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product].  Specifically, ***
3557 21 CFR 211.52 5 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, ***
4302 21 CFR 211.56(b) 5 Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, ***
4350 21 CFR 211.160(b)(3) 5 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, ***
4353 21 CFR 211.160(b)(4) 5 Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, ***
4368 21 CFR 211.188(b)(12) 5 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, ***
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, ***
4382 21 CFR 211.198(b)(2) 5 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, ***
4418 21 CFR 211.42(b) 5 Adequate space lacking  to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination.  Specifically, ***
6736 21 CFR 314.80(c)(1)(ii) 5 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, ***
6831 21 CFR 314.80(c)(2) 5 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, ***
17722 21 CFR 212.10 5 Lack Adequate Resources, Facilities, Equipment. You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions.  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, ***
1393 21 CFR 211.103 4 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person.  Specifically, ***
1504 21 CFR 211.122(d) 4 Labels and labeling stored  separately Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.  Specifically, ***
1545 21 CFR 211.125(c) 4 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, ***
1633 21 CFR 211.130(d) 4 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, ***
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, ***
1774 21 CFR 211.142(a) 4 Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.  Specifically, ***
1777 21 CFR 211.150(b) 4 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,  ***
1842 21 CFR 211.84(d)(1) 4 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,***
1843 21 CFR 211.84(d)(2) 4 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,  ***
1868 21 CFR 211.94(b) 4 Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.  Specifically, ***
1876 21 CFR 211.180(a), (b) 4 Record maintenance 1 year (except exempt OTC) All records of  [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date.  Specifically, ***
1917 21 CFR 211.166(a)(1) 4 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, ***
1922 21 CFR 211.166(a)(4) 4 Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.  Specifically, ***
1928 21 CFR 211.166(c)(1) 4 Homeopathic drugs, assessment of stability There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use].  Specifically, ***
2003 21 CFR 211.184(c) 4 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, ***
2033 21 CFR 211.194(c) 4 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, ***
2034 21 CFR 211.194(d) 4 Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, ***
2567 21 CFR 211.198(a) 4 Adverse Drug Experience Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent [serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***
2569 21 CFR 211.198(b) 4 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, ***
3445 21 CFR 211.65(a) 4 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, ***
3594 21 CFR 211.110(d) 4 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, ***
4373 21 CFR 211.188(b)(7) 4 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, ***
4388 21 CFR 211.198(a) 4 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, ***
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, ***
4410 21 CFR 211.194(a)(5) 4 Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***
6728 21 CFR 314.80(b) 4 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, ***
17741 21 CFR 212.30(b) 4 Equipment not clean You did not implement procedures to ensure that all your equipment is clean.  Specifically, ***
17742 21 CFR 212.30(b) 4 Equipment not suitable You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.  Specifically,***
17851 21 CFR 212.60(c) 4 Analytical methods Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible].  Specifically,***
1174 21 CFR 211.42(b) 3 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, ***
1722 21 CFR 211.134(a) 3 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, ***
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, ***
1798 21 CFR 211.82(b) 3 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, ***
1851 21 CFR 211.84(e) 3 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, ***
1927 21 CFR 211.166(b) 3 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, ***
1933 21 CFR 211.167(a) 3 Sterility/pyrogens - test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed].  Specifically, ******
2035 21 CFR 211.194(e) 3 Stability testing records not  included Laboratory records do not include complete records of all stability testing performed.  Specifically, ***
3553 21 CFR 211.48(a) 3 Plumbing System Defects The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, ***
3562 21 CFR 211.56(c) 3 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, ***
3569 21 CFR 211.89 3 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, ***
3582 21 CFR 211.105(a) 3 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, ***
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, ***
3614 21 CFR 211.160(b)(4) 3 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, ***
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, ***
3639 21 CFR 211.204 3 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [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, ***
4328 21 CFR 211.122(a) 3 Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, ***
4330 21 CFR 211.130(e) 3 Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, ***
4343 21 CFR 211.160(b)(1) 3 Incoming lots - conformance to written specs- Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of drug products.  Specifically, ***
4344 21 CFR 211.160(b)(1) 3 Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, ***
4356 21 CFR 211.166(b) 3 Tentative expiration date Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the appropriate expiration date determined.  Specifically, ***
4369 21 CFR 211.188(b)(11) 3 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, ***
4371 21 CFR 211.188(b)(9) 3 Description of containers and closures Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced.  Specifically, ***
4400 21 CFR 211.186(b)(8) 3 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, ***
4404 21 CFR 211.194(a)(1) 3 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, ***
4409 21 CFR 211.194(a)(4) 3 Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested].  Specifically, ***
6832 21 CFR 314.80(c)(2) 3 Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.  Specifically, ***
6842 21 CFR 314.80(i) 3 Failure to maintain records Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period.  Specifically, ***
8912 21 CFR 314.81(b)(2) 3 Timely submission An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application.   Specifically, ***
17850 21 CFR 212.60(b) 3 Lab sampling and test procedures Each laboratory did not have sampling procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
17932 21 CFR 212.60(b) 3 Testing Procedures- Conformance to Standards Each laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
17940 21 CFR 212.71(a) 3 Non-Conforming Product Investigation Incomplete The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the [processes] [operations] [records] [complaints] [other relevant sources of information] concerning the nonconforming product. Specifically***
1079 21 CFR 211.22(a) 2 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, ***
1218 21 CFR 211.67(b)(1) 2 Cleaning SOP/responsibility Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.  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, ***
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,***
1449 21 CFR 211.111 2 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, ***
1456 21 CFR 211.115(b) 2 Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, ***
1496 21 CFR 211.122(a) 2 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) 2 Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, ***
1630 21 CFR 211.130(b) 2 Unlabeled filled containers controls Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of individual containers, lots or portions of lots.  Specifically, ***
1637 21 CFR 211.130(e) 2 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, ***
1724 21 CFR 211.134(b) 2 Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, ***
1791 21 CFR 211.80(c) 2 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, ***
1797 21 CFR 211.82(a) 2 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, ***
1846 21 CFR 211.84(d)(3) 2 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, ***
1958 21 CFR 211.180(f) 2 Responsible firm officials notified in writing Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions,  are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices].  Specifically, ***
1978 21 CFR 211.182 2 Personnel  dating/signing equipment log The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, ***
2014 21 CFR 211.188(b)(2) 2 Identification of Equipment and Lines The batch production and control records are deficient in that they do not  include the identity of major [equipment] [lines] used.  Specifically, ***
2196 21 CFR 211.186(b)(1) 2 Product Name and Strength The master production and control records are deficient in that they do not  include the [name] [strength] of the drug product and a description of the dosage form.  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, ***
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, ***
3550 21 CFR 211.46(c) 2 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, ***
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, ***
3573 21 CFR 211.101(b) 2 Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, ***
3581 21 CFR 211.101(d) 2 Verification of component addition Each component is not added to the batch by one person and verified by a second person..  Specifically, ***
3588 21 CFR 211.110(a)(3) 2 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, ***
3592 21 CFR 211.110(c) 2 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, ***
3610 21 CFR 211.160(b)(3) 2 Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  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, ***
4304 21 CFR 211.68(b) 2 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, ***
4307 21 CFR 211.80(d) 2 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, ***
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, ***
4355 21 CFR 211.165(c) 2 Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***
4360 21 CFR 211.170(b) 2 Reserve drug product sample quantity - all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.  Specifically, ***
4366 21 CFR 211.188(a) 2 Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was  checked for accuracy, dated and signed.  Specifically, ***
4374 21 CFR 211.188(b)(6) 2 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, ***
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, ***
4386 21 CFR 211.198(b) 2 Written complaint record  to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or packed provided the written records are readily available for inspection at that other facility].  Specifically, ***
4403 21 CFR 211.194(b) 2 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, ***
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, ***
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, ***
4416 21 CFR 211.204 2 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, ***
6735 21 CFR 314.80(c)(1)(ii) 2 Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated.  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, ***
6833 21 CFR 314.80(c)(2)(ii) 2 Incomplete periodic safety report Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences].  Specifically, ***
8935 FDCA 760(b)(1) 2 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, ***
17743 21 CFR 212.30(b) 2 Equipment procedures overall You did not implement procedures to ensure that all your equipment is [properly installed] [maintained] [capable of repeatedly producing valid results].  Specifically,***
17745 21 CFR 212.30(b) 2 Equipment not properly maintained You did not document your activities in accordance with your procedures for ensuring the equipment suitability for its intended purposes.  Specifically,***
17755 21 CFR 212.20(a) 2 Oversight of production operations You did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is supposed to have].  Specifically, ***
17769 21 CFR 212.40(a) 2 Content of written procedures You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures].  Specifically,***
17772 21 CFR 212.40(b) 2 Written specs  - components You did not establish appropriate written specifications for the [identity] [quality] [purity] of components.  Specifically,***
17813 21 CFR 212.50(a) 2 Written control procedures You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified].  Specifically,***
17842 21 CFR 212.50(d) 2 Records of checks made You did not keep a record of checks of the [production area] [all equipment in the production area] for cleanliness and suitability immediately before use.  Specifically,***
17849 21 CFR 212.60(a) 2 Testing procedures Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug products] does not [have written procedures] [follow written procedures] for the conduct of each test.  Specifically,***
17858 21 CFR 212.60(f) 2 Documenting procedures You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment. Specifically,***
17859 21 CFR 212.60(g) 2 Test records complete (general) Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,***
17883 21 CFR 212.70(d)(3) 2 Final dated signature You did not [establish] [follow] procedures to ensure that a PET drug was not given final release before a designated qualified individual authorized the final release by dated signature.  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, ***
1168 21 CFR 211.34 1 Consultant Records Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided].  Specifically, ***
1219 21 CFR 211.67(b)(2) 1 Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.  Specifically, ***
1220 21 CFR 211.67(b)(3) 1 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) 1 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, ***
1224 21 CFR 211.67(b)(6) 1 Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before 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, ***
1256 21 CFR 211.68(b) 1 Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.  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, ***
1384 21 CFR 211.101(c) 1 Weighing/measuring/subdividing operations Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, ***
1396 21 CFR 211.42(c)(2) 1 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,***
1411 21 CFR 211.105(b) 1 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, ***
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, ***
1436 21 CFR 211.42(c)(10)(vi) 1 Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, ***
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, ***
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, ***
1794 21 CFR 211.80(d) 1 Disposition recorded by lot identification The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.  Specifically, ***
1796 21 CFR 211.80(d) 1 Identification of Each Lot in Each Shipment Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures].  Specifically, ***
1818 21 CFR 211.84(c)(2) 1 Appropriate Opening of Component Containers The containers of components, or drug product containers or closures which are sampled are not opened in a manner to prevent [contamination of their contents] [contamination of other components] [contamination of other drug product containers] [contamination of other closures].  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, ***
1845 21 CFR 211.84(d)(3) 1 Container/Closure Written Test Procedure Drug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance with  appropriate written procedures.  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,  ***
1852 21 CFR 211.94(a) 1 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, ***
1870 21 CFR 211.94(d) 1 Written Procedures to Remove Pyrogens There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties.  Specifically, ***
1938 21 CFR 211.167(c) 1 Controlled release dosage form testing Each batch  of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.  Specifically, ***
1941 21 CFR 211.180(d) 1 Reader/Photocopy equipment not made  available Suitable reader or photocopying equipment was not made readily available for [drug product] [component] records maintained using reduction techniques.  Specifically, ***
1957 21 CFR 211.180(e)(2) 1 Review of problem drugs The procedures for the annual quality standards record evaluation are deficient in that they do not  address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product.  Specifically, ***
1999 21 CFR 211.184(a) 1 Record information required The records for [components] [drug product containers or closures] [labeling]  do not include the [identity and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number]  [receiving code] [date of receipt] [name of the prime manufacturer if different from the supplier] [location of the prime manufacturer].  Specifically, ***
2020 21 CFR 211.188(b)(8) 1 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, ***
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, ***
2200 21 CFR 211.186(b)(4) 1 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, ***
2201 21 CFR 211.186(b)(5) 1 Calculated Excess of Components Used The master production and control records are deficient in that they do not include a statement concerning any calculated excess of component. Specifically, ***
2402 21 CFR 211.194(a)(5) 1 Testing Calculations Laboratory records are deficient in that they do not include all calculations performed during testing.  Specifically, ***
2406 21 CFR 211.194(a)(8) 1 Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, ***
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, ***
2572 21 CFR 211.198(b) 1 Complaint File Location Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing site nor were they readily available from their off-site location.  Specifically, ***
2621 21 CFR 211.198(b)(3) 1 Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, ***
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, ***
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, ***
3567 21 CFR 211.84(d)(2) 1 Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, ***
3597 21 CFR 211.122(g)(3) 1 Visual inspection The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for [100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling] [examination to be performed by one person and independently verified by a second person].  Specifically, ****
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, ***
4310 21 CFR 211.84(c)(3) 1 Sterile Equipment, Aseptic Techniques in sample collecting Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample.  Specifically, ***
4313 21 CFR 211.84(c)(6) 1 Containers Marked to Show Samples Taken Containers from which samples have been taken are not marked to show that samples have been taken from them.  Specifically, ***
4316 21 CFR 211.84(d)(3) 1 Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, ***
4322 21 CFR 211.101(d) 1 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, ***
4325 21 CFR 211.110(a) 1 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,***
4349 21 CFR 211.160(b)(2) 1 In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, ***
4354 21 CFR 211.165(d) 1 Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, ***
4370 21 CFR 211.188(b)(10) 1 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, ***
4375 21 CFR 211.188(b)(5) 1 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) 1 Weights and measures of components used Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.  Specifically, ***
4379 21 CFR 211.188(b)(1) 1 Dates not included for each significant step Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced.  Specifically, ***
4387 21 CFR 211.198(a) 1 Reporting of adverse drug experience to FDA Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.  Specifically, ***
4390 21 CFR 211.180c) 1 Photocopying of records not allowed Records or copies of records were not made  available for photocopying or other means of reproduction.  Specifically, ***
4411 21 CFR 211.194(a)(6) 1 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, ***
4412 21 CFR 211.194(a)(7) 1 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, ***
4414 21 CFR 211.204 1 Record information maintained Records of returned drug products are not maintained.  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, ***
6827 21 CFR 314.80(c)(1)(iv) 1 Failure to identify report content Each post marketing 15-day Alert report submitted to FDA did not have its contents prominently identified, i.e. [post marketing 15-day report] [post marketing 15-day report follow-up].  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, ***
6835 21 CFR 314.80(d)(1) 1 Failure to submit scientific article Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article.  Specifically, ***
6838 21 CFR 314.80(e)(1) 1 Failure to report post-marketing study ADEs Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience.  Specifically, ***
8914 21 CFR 314.81(b)(2)(iv)(b) 1 Mfg and control changes not requiring a supplemental app. An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.   Specifically, ***
8922 21 CFR 314.81(b)(2)(viii) 1 Post marketing study status report for other studies An annual report did not include a status report for all post marketing studies being performed by, or on behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii).  Specifically, ***
17002 FDCA 501(a) 1 Drug Field Exam During a field examination of drug products at your facility the following [was] [were] observed:
17744 21 CFR 212.30(b) 1 Equipment not properly installed You did not document your activities in accordance with your procedures for cleaning all of your equipment.  Specifically,***
17753 21 CFR 212.30(c) 1 Contact surfaces Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.  Specifically,***
17757 21 CFR 212.20(b) 1 Examine, approve or reject You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug.  Specifically,***
17761 21 CFR 212.20(c) 1 Proposed changes to existing specs/methods You did not approve or reject, before implementation, proposed changes to existing [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug.  Specifically,***
17765 21 CFR 212.20(d) 1 Review of records for errors You did not review production records to determine whether errors had occurred.  Specifically,***
17770 21 CFR 212.40(a) 1 Suitable for intended use Your written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use.  Specifically,***
17821 21 CFR 212.50(b)(6) 1 Action limits on radiochemical yield Your master production and control records did not contain a statement of action limits on radiochemical yield.  Specifically,***
17822 21 CFR 212.50(b)(7) 1 Complete instructions, procedures, specs Your master production and control records did not contain [complete production and control instructions] [complete sampling and testing procedures] [complete specifications] [special notations] [precautions to be followed].  Specifically,***
17823 21 CFR 212.50(b)(8) 1 Container & label descriptions Your master production and control records did not contain [a description of the PET drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling].  Specifically,***
17832 21 CFR 212.50(c)(4) 1 Each major production step Your batch production records do not [always] include each major production step (obtained from the approved appropriate master production and control record).  Specifically,***
17846 21 CFR 212.50(f)(2) 1 Documentation of activities You did not document your process verification [activities] [results].  Specifically,***
17853 21 CFR 212.60(d) 1 Supplies adequately controlled Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled.  Specifically,***
17855 21 CFR 212.60(e) 1 Equipment All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results].  Specifically,***
17865 21 CFR 212.60(g)(5) 1 Initials, signature, date Laboratory test records did not contain the initials or signature of the person performing the test. Specifically,***
17869 21 CFR 212.61(a) 1 Samples representative, stored properly The samples tested for stability were [not representative of the lot or batch from which they were obtained] [not stored under suitable storage conditions].  Specifically,***
17870 21 CFR 212.61(b) 1 Use of stability test results The stability test results were not [documented] [used in determining appropriate storage conditions] [used in determining appropriate expiration dates and times] for each PET drug product you produce.  Specifically,***
17872 21 CFR 212.70(a) 1 Specifications You did not establish [adequate] specifications for each PET drug product, including criteria for determining [identity, strength, quality and purity] [sterility] [pyrogens].  Specifically,***
17874 21 CFR 212.70(b) 1 Before implementing new procedure establish accuracy etc. You implemented a new test procedure in a specification, but you did not first [establish] [document] the [accuracy] [sensitivity] [specificity] [reproducibility] of the procedure.  Specifically,***
17877 21 CFR 212.70(c) 1 Conform to specs prior to release You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release.  Specifically,***
17886 21 CFR 212.70(e) 1 When 30 hour rule is exceeded A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.  Specifically,***
17896 21 CFR 212.71(a) 1 Rejection of nonconforming product You did not reject the batch of a PET drug product that did not conform to specifications.  Specifically,***
17897 21 CFR 212.71(b) 1 Investigation of nonconforming product You did not [completely] document the investigation of a PET drug product that did not meet specifications. Specifically,***
17898 21 CFR 212.71(c) 1 Correction of problems You did not take [appropriate] action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.  Specifically,***
17904 21 CFR 212.80(d) 1 Labeling and product mix-ups Labeling and packaging operations for PET drug products were not controlled to prevent labeling and product mix-ups.  Specifically,***
17913 21 CFR 212.100(a) 1 Written complaint procedures You have not [developed] [followed] written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product.  Specifically,***
17927 21 CFR 212.110(b) 1 Record quality All records including those not stored at your inspected establishment are not [legible]  [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees].  Specifically,***
17937 21 CFR 212.70(e) 1 Notification to Facilities Re: Received PET Drug Sterility You did not notify all facilities that received a PET drug product that failed to meet a criterion for sterility of the findings from your investigation. Specifically***
17939 21 CFR 212.71(a) 1 Procedures to Investigate Cause of Non-Conforming Product You did not [establish] [follow] procedures to investigate the cause(s) of the nonconforming batch(s) of a PET drug product. Specifically, ***
17941 21 CFR 212.71(b) 1 Documentation of Non-Conforming Product Investigation You did not document [the results of the investigation] [what happened to the rejected PET drug product] for a PET drug product that did not meet specifications.  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) 213 Record keeping Treatment records were not [maintained] [complete]. Specifically,***
4093 21 CFR 530.11(d) 138 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) 64 Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically, ***
1360 FDCA 501(a)(5) 45 Expired drugs Expired drug(s) were observed in the drug storage area. Specifically, ***
4182 FDCA 501(a)(5) 39 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, ***
13509 FDCA 402(a)(4) 33 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) 29 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, ***
1442 FDCA 402(a)(4) 27 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, ***
4097 21 CFR 530.20(a)(2)(iv) 26 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, ***
13521 21 CFR 530.41(a) 24 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, ***
1366 21 CFR 530.11(a) 23 Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
13508 FDCA 402(a)(4) 23 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, ***
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, ***
1362 21 CFR 530.11(a) 21 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, ***
4184 FDCA 501(a)(5) 18 Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
1446 FDCA 402(a)(4) 17 Hospital pen Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
1457 FDCA 402(a)(4) 14 Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
1373 21 CFR 530.11(a) 12 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, ***
4094 21 CFR 530.11(b) 12 Use in animal feed An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***
4099 21 CFR 530.20(a)(2)(ii) 12 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, ***
1376 21 CFR 530.11(a) 10 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, ***
1389 21 CFR 530.11(a) 10 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, ***
1850 21 CFR 225.58(d) 6 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,***
4098 21 CFR 530.20(a)(2)(i) 6 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, ***
2097 21 CFR 225.102(b)(4) 5 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, ***
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, ***
4131 21 CFR 589.2000(c)(1)(i) 5 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) 5 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***
1469 21 CFR 225.20(b)(3) 4 Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. 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, ***
4100 21 CFR 530.20(a)(2)(iii) 4 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, ***
4545 21 CFR 225.120 4 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***
13567 21 CFR 589.2001(c)(2)(iv) 4 Label "Do not feed to animals" Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals". Specifically,***
1575 21 CFR 225.42(b)(4) 3 Integrity and identity Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***
1638 21 CFR 225.42(b)(5) 3 Elements of receipt record Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's lot number or other identifying number] [date of receipt] [condition of the drug when received] [return of any damaged drugs] for each lot of drug received. Specifically, ***
1782 21 CFR 225.42(b)(7) 3 Daily comparison, actual vs theoretical A daily comparison is not made between the actual amount of drug used and the theoretical amount of drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds manufactured. Specifically, ***
1792 21 CFR 225.42(b)(7) 3 Discrepancies Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage. Specifically, ***
1811 21 CFR 225.58(b)(1) 3 Three assays per year Periodic assays are not performed during the calendar year on at least three representative samples of medicated feeds requiring a medicated feed mill license, for each drug or drug combination used. Specifically, ***
2076 21 CFR 225.102(b)(1) 3 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, *** "
4147 21 CFR 589.2000(e)(1) 3 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, ***
4542 21 CFR 225.102((a) 3 Lack of Production Record(s) Failure to have production record(s) for specific products which include the complete history of each batch or production run. Specifically, ***
4560 21 CFR 225.165 3 Establishment and use of adequate procedures Adequate procedures are not [established] [used] for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds. Specifically, ***
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, ***
13568 21 CFR 589.2001(c)(2)(v) 3 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,***
1466 21 CFR 225.20(b)(2) 2 Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
1482 21 CFR 225.30(b)(1) 2 Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, ***
1953 21 CFR 225.80(b)(2) 2 Maintaining proofread label Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the labels from that batch have been used]. Specifically, ***
2075 21 CFR 225.102(b)(1) 2 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, ***
2232 21 CFR 225.115(b)(1) 2 Maintaining records of complaints The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is not maintained on the premises. Specifically, ***
4552 21 CFR 225.142 2 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, ***
4553 21 CFR 225.142 2 Packaged Type A and Type B designated areas The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers]. Specifically, ***
4557 21 CFR 225.158 2 Investigation and corrective action Results of laboratory assays of drug components indicated that medicated feed was not in accord with the permissible limits, and no [investigation] [corrective action] was implemented immediately. Specifically, ***
13565 21 CFR 589.2001(c)(2)(ii) 2 Renderer's maintaining adequate written procedures Failure to maintain adequate written procedures specifying how the process of [removing the brain and spinal cord from cattle not inspected and passed for human consumption] [separating animals based on whether or not they are 30 months of age or older] is carried out. Specifically,***
1491 21 CFR 225.30(b)(2) 1 Maintenance reasonably clean & orderly Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
1493 21 CFR 225.30(b)(4) 1 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, ***
1535 21 CFR 225.42(b)(2) 1 Storage of packaged drugs Packaged drugs are not stored in their original closed containers. Specifically, ***
1744 21 CFR 225.42(b)(6) 1 Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***
1765 21 CFR 225.42(b)(6)(i) - (v) 1 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, ***
1821 21 CFR 225.58(b)(1) 1 First batch assay No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license. Specifically, ***
1826 21 CFR 225.58(b)(1) 1 Alternate testing of drugs in combination Where only one drug is assayed in a medicated feed containing a combination of drugs, there was a failure to test a different drug from the one(s) previously tested during the calendar year. Specifically,***
1923 21 CFR 225.65(b) 1 Reasonable and effective procedures followed All equipment that comes in contact with [active drug components] [feeds in process] [finished medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed. Specifically, ***
1954 21 CFR 225.80(b)(3) 1 Complete Bulk Labeling Where medicated feeds are distributed in bulk, complete labeling [does not accompany the shipment] [is not supplied the consignee at the time of delivery]. 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, ***
2093 21 CFR 225.102(b)(2)(i)-(iv) 1 Elements of production record(s) Production record(s) fail to include [the product identification] [the date of production] [a written endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of drug components used] [the theoretical quantity of medicated feed to be produced] [the actual quantity of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based on the basis for the estimate in the MRF]. Specifically, ***
2098 21 CFR 225.102(b)(4) 1 Discrepancies investigated, reported When significant discrepancies were noted on the batch production records, there was a failure to [institute an investigation immediately] [describe the corrective action taken on the production record]. Specifically, ***
2189 21 CFR 225.110(b)(1) 1 Distribution record elements Distribution record(s) for medicated feeds fail to include the [date of shipment] [name and address of purchaser] [quantity shipped] [name of the medicated feed] [lot, control number, date of manufacture, or other suitable identification]. Specifically, ***
2245 21 CFR 226.20(b) 1 Lighting, ventilation, screening, dust, temperature Buildings used for the [production] [packaging] [labeling] [holding] of Type A medicated articles do not provide adequate [lighting] [ventilation] [screening] [dust control] [temperature control] to avoid contamination of such articles. Specifically, ***
2353 21 CFR 226.58(b) 1 Specifications, test procedures - Type A medicated articles Laboratory controls do not include [the establishment of adequate specifications] [a description of laboratory test procedures to check specifications] to assure that Type A medicated articles conform to appropriate specifications. Specifically, ***
2375 21 CFR 226.40(b) 1 Container receipt, identification, storage, and handling Containers to be used for [undiluted drugs] [drug components] [intermediate mixtures] [Type A medicated articles] are not [received] [adequately identified] [properly stored] [handled] in a manner to avoid mix-ups and contamination. Specifically, ***
2378 21 CFR 226.40(d) 1 Distribution despite discrepancies in yield Key personnel did not prevent distribution of a batch [and other associated batches] of a Type A medicated article where significant discrepancies were found when checking the actual against theoretical yield of the batch. Specifically, ***
4101 21 CFR 530.20(a)(1) 1 Approved drug available Failure to determine that an approved animal drug was clinically ineffective for its intended use in a food-producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the drug's labeling. Specifically, ***
4108 21 CFR 530.12(a) 1 Name and address - drug dispensed by veterinarian Failure to provide labeling showing the name and address of the prescribing veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4112 21 CFR 530.12(d) 1 Cautionary statements Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4113 21 CFR 530.12(e) 1 Withdrawal, withholding, or discard time Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
4137 21 CFR 589.2000(d)(1) 1 Maintaining records Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track the materials throughout their receipt, processing, and distribution. Specifically, ***
4145 21 CFR 589.2000(e)(1) 1 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***
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, ***
4158 21 CFR 225.80(b)(4) 1 Label stock review Label stock is not [reviewed periodically] [discarded when discontinued labels are found]. Specifically, ***
4159 21 CFR 226.58(d) 1 Components uniformly dispersed and stable No determination has been made that the drug components remain uniformly dispersed and stable in Type A medicated articles under ordinary conditions of shipment, storage and use. Specifically, ***
4183 FDCA 501(a)(5) 1 Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed]. 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, ***
4541 21 CFR 225.42(b) 1 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, ***
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, ***
4555 21 CFR 225.142 1 Use in accord with directions All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***
4558 21 CFR 225.158 1 Records kept for one year Records of [investigation] [corrective action] with respect to assays of drug components not meeting permissible levels are not maintained on the premises for a period of one year. Specifically, ***
4562 21 CFR 225.180 1 Assuring correct labels are used Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the medicated feed]. Specifically, ***
4564 21 CFR 225.180 1 Bagged or bulk deliveries All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used. Specifically, ***
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, ***
13532 21 CFR 511.1(b)(7)(ii) 1 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, ***
13558 21 CFR 589.2001(c)(1) 1 Cattle 30 months and older used in feed Animal feed or feed ingredients are manufactured from, processed with, or otherwise contain material prohibited material from cattle not inspected and passed for human consumption that are 30 months of age or older and from which brains and spinal cords were not [effectively removed] [effectively excluded]. Specifically,***
13564 21 CFR 589.2001(c)(2)(i) 1 Exclude entire carcass not inspected and passed Failure to exclude from use in animal food the entire carcass of cattle not inspected and passed for human consumption when the brain and spinal cord are not effectively removed and such cattle are 30 months of age or older. Specifically,***
13566 21 CFR 589.2001(c)(2)(iii) 1 Cross contamination of cattle materials Failure to provide for measures to avoid cross-contamination by use of [separate equipment] [separate containers] once cattle materials prohibited in animal feed have been separated from other cattle materials. Specifically,***
13569 21 CFR 589.2001(c)(2)(vi) 1 Tracking records: establish, maintain, make available Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed. Specifically,***
13571 21 CFR 589.2001(c)(3)(i) 1 Records:establish, maintain, make available Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, cattle materials prohibited in animal feed. Specifically,***
13572 21 CFR 589.2001(c)(3)(i) 1 Records about firms supplying segregated cattle materials With respect to cattle materials obtained from establishments which have segregated cattle materials prohibited in animal feed, there is a failure to [establish] [maintain] [make available to FDA] records demonstrating that such establishments have adequate procedures in place to effectively exclude cattle materials prohibited in animal feed. Specifically,***

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Bioresearch monitoring

Center Name Cite Id Ref No Frequency Short Description Long Description
Bioresearch monitoring 7560 21 CFR 312.60 129 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) 85 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, ***
7318 21 CFR 56.115(a)(2) 30 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, ***
7526 21 CFR 312.62(a) 24 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) 23 Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***
7334 21 CFR 56.115(a)(5) 19 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, ***
7227 21 CFR 50.27(a) 18 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, ***
7498 21 CFR 312.66 15 Unanticipated problems Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, ***
7482 21 CFR 312.50 14 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, ***
7562 21 CFR 312.60 14 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***
7290 21 CFR 56.108(c) 12 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, ***
7231 21 CFR 50.20 9 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, ***
7335 21 CFR 56.115(a)(6) 9 Written procedures per 56.108(a) and (b) Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).  Specifically, ***
7293 21 CFR 56.109(f) 8 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, ***
7320 21 CFR 56.109(e) 8 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, ***
7520 21 CFR 312.64(b) 8 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, ***
7371 21 CFR 56.108(a)(1) 7 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, ***
3926 21 CFR 58.35(b)(1) 6 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, ***
7305 21 CFR 56.110(b)(2) 6 Minor changes The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature.  Specifically, ***
7316 21 CFR 56.115(a)(4) 6 Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators.  Specifically, ***
7370 21 CFR 56.111(c) 6 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, ***
7388 21 CFR 50.25(a)(2) 6 Reasonably foreseeable risks or discomforts The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.  Specifically, ***
3914 21 CFR 58.31(f) 5 Management: personnel understand their functions Testing facility management failed to assure that all personnel clearly understood the functions they were to perform.  Specifically, ***
3931 21 CFR 58.35(b)(5) 5 QAU: authorize deviations from protocols or SOPs The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation.  Specifically, ***
7274 21 CFR 56.107(a) 5 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, ***
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, ***
7337 21 CFR 56.115(b) 5 Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research.  Specifically, ***
7342 21 CFR 56.108(b)(2) 5 Prompt reporting of noncompliance The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA]  of any instance of serious or continuing noncompliance with theses regulations or the requirements or determinations of the IRB.  Specifically, ***
7368 21 CFR 56.108(a)(2) 5 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, ***
7507 21 CFR 312.52(a) 5 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, ***
7517 21 CFR 312.66 5 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, ***
7654 21 CFR 56.110(b) 5 Research not eligible for expedited review The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year].   Specifically, ***
3902 21 CFR 58.29(a) 4 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, ***
3918 21 CFR 58.33(a) 4 Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed.  Specifically, ***
3954 21 CFR 58.63(a) 4 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) 4 SOPs: required Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals].  Specifically, ***
4007 21 CFR 58.130(a) 4 Conduct: in accordance with protocol Not all nonclinical laboratory studies were conducted in accordance with the protocol.  Specifically, ***
4035 21 CFR 58.190(a) 4 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, ***
7321 21 CFR 56.110(c) 4 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, ***
7353 21 CFR 50.52 4 Factors required for approval The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being.  However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55].  Specifically, ***
7480 21 CFR 312.50 4 Ensuring compliance with plan and protocol Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.  Specifically, ***
7531 21 CFR 312.62(c) 4 Record retention Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA].   Specifically, ***
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, ***
3924 21 CFR 58.35(a) 3 QAU: monitor facilities, etc. The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations.  Specifically, ***
3932 21 CFR 58.35(b)(6) 3 QAU: review final study report The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study.  Specifically, ***
3957 21 CFR 58.81(a) 3 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, ***
4012 21 CFR 58.130(e) 3 Conduct: date and sign Not all data entries were dated on the date of entry and signed or initialed by the person entering the data.  Specifically, ***
7209 21 CFR 50.25(a)(1) 3 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, ***
7286 21 CFR 56.108(b)(1) 3 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, ***
7343 21 CFR 56.108(b)(3) 3 Reporting  of suspension/termination The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .  Specifically, ***
7384 21 CFR 50.25(b)(1) 3 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, ***
7385 21 CFR 50.25(b)(3) 3 Possible additional costs to the subject The informed consent document did not include a statement of any additional costs to the subject that might result from participation in the research, as appropriate.  Specifically, ***
7392 21 CFR 50.25(a)(7) 3 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) 3 Investigator statement (FDA 1572) Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.  Specifically, ***
7453 21 CFR 312.56(b) 3 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, ***
7459 21 CFR 312.57(a) 3 Records of receipt, shipment, disposition Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug.  Specifically, ***
7479 21 CFR 312.56(a) 3 Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND.  Specifically, ***
7552 21 CFR 312.66 3 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation.  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, ***
3948 21 CFR 58.47(a)(3) 2 Facility: article mixture storage areas The testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for storage of the test and control article mixtures.  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, ***
3958 21 CFR 58.81(a) 2 SOPs: authorization and documentation of deviations Not all deviations from standard operating procedures in a study were authorized by the study director and  documented in the raw data.  Specifically, ***
3961 21 CFR 58.81(c) 2 SOPs: availability Not all laboratory areas have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed.  Specifically, ***
4025 21 CFR 58.185(a)(9) 2 Final report: circumstances affecting data qual., integrity The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data.  Specifically, ***
4029 21 CFR 58.185(a)(13) 2 Final report: storage locations The final study report did not include the locations where all [specimens] [raw data] [the final report] are to be stored.  Specifically, ***
4047 21 CFR 58.195(g) 2 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, ***
7278 21 CFR 56.107(e) 2 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, ***
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, ***:
7319 21 CFR 56.115(a)(3) 2 Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities.  Specifically, ***
7333 21 CFR 56.104(c) 2 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) 2 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, ***
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, ***
7391 21 CFR 50.25(a)(5) 2 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, ***
7393 21 CFR 50.25(a)(8) 2 Participation; refusal and discontinuance The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled].  Specifically, ***
7456 21 CFR 312.57(d) 2 Bioequivalence samples Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were not [retained] [released to FDA upon request as required by 21 CFR Part 320.138].  Specifically, ***
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, ***
7665 21 CFR 50.20 2 Exculpatory language, waiving of rights The general requirements for informed consent were not met in that the consent form contained exculpatory language [through which the subject or the subject's representative was made to waive or appear to waive some of the subject's legal rights] [that released or appeared to release the investigator, sponsor, the institution, or its agents from liability for negligence].  Specifically, ***
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, ***
3912 21 CFR 58.31(d) 1 Management: testing of test and control articles Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.  Specifically, ***
3920 21 CFR 58.33(c) 1 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, ***
3921 21 CFR 58.33(d) 1 Study director: test system specified in protocol The study director failed to assure that test systems were as specified in the protocol.   Specifically, ***
3922 21 CFR 58.33(e) 1 Study director: follow GLP regulations The study director failed to assure that all applicable GLP regulations were followed.  Specifically, ***
3923 21 CFR 58.33(f) 1 Study director: transfer of data to archives The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study.  Specifically, ***
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, ***
3928 21 CFR 58.35(b)(3) 1 QAU: inspect study at adequate intervals The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection.  Specifically, ***
3929 21 CFR 58.35(b)(3) 1 QAU: problems affecting study integrity The quality assurance unit failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity.  Specifically, ***
3934 21 CFR 58.35(c) 1 QAU: SOPs and required records The quality assurance unit failed to maintain and make available for inspection required records regarding its responsibilities and procedures and the method of indexing such records.  Specifically, ***
3943 21 CFR 58.45 1 Facility: supply storage areas The testing facility does not provide storage areas, as needed, for feed, bedding, supplies, and equipment.  Specifically, ***
3953 21 CFR 58.63(a) 1 Equipment: inspection, cleaning and maintenance Not all equipment is adequately inspected, cleaned, and maintained.  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, ***
3956 21 CFR 58.63(c) 1 Equipment: maintenance records Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations.  Specifically, ***
3962 21 CFR 58.81(d) 1 SOPs: historical file A historical file of standard operating procedures, and all revisions, including the dates of such revisions, was not maintained.  Specifically, ***
3964 21 CFR 58.83 1 Reagents: outdated Deteriorated or outdated reagents and solutions were used.  Specifically, ***
3978 21 CFR 58.90(g) 1 Animal care: feed and water analysis records Not all feed and water analyses for contaminants were maintained as raw data.  Specifically, ***.
3986 21 CFR 58.105(c) 1 Test article: storage container labeling Not all storage containers for a test or control article were labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article.  Specifically, ***
3990 21 CFR 58.113(a)(1) 1 Mixtures: uniformity and concentration Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in the mixture].  Specifically, ***
3999 21 CFR 58.120(a)(6) 1 Protocol: experimental design Not all protocols contained a description of the experimental design, including the methods for the control of bias.  Specifically, ***
4006 21 CFR 58.120(b) 1 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, ***
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, ***
4014 21 CFR 58.130(e) 1 Conduct: identification of individual inputting data In automated data collection systems, the individual responsible for direct data input was not identified at the time of data input.  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, ***
4030 21 CFR 58.185(a)(14) 1 Final report: statement by QAU The final study report did not include the statement prepared and signed by the quality assurance unit as required by FDA Good Laboratory Practice regulations.  Specifically, ***
4032 21 CFR 58.185(c) 1 Final report: corrections or additions Not all corrections or additions to a final report were in the form of an amendment by the study director.  Specifically, ***
4038 21 CFR 58.190(b) 1 Archives: reference other storage locations The testing facility archive failed to specifically reference other locations where raw data or specimens are stored.  Specifically, ***
4039 21 CFR 58.190(c) 1 Archives: individual responsible An individual was not identified as responsible for the archives.  Specifically, ***
4040 21 CFR 58.190(d) 1 Archives: unauthorized personnel Unauthorized personnel entered the archives.  Specifically, ***
7277 21 CFR 56.107(d) 1 One non-affiliate member The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution.  Specifically, ***
7279 21 CFR 56.107(f) 1 Invited individual allowed to vote with IRB The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB.  Specifically, ***
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, ***
7340 21 CFR 56.108(a)(3) 1 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, ***
7352 21 CFR 50.51 1 Provisions for soliciting assent and permission For a clinical investigation in which no greater than minimal risk to children as subjects was presented, the IRB did not [find] [document] that adequate provisions had been made for [soliciting the assent of the children] [soliciting the permission of the parents or guardians of the children] as set forth at 21 CFR 50.55.  Specifically, ***
7359 21 CFR 50.55(b) 1 Adequate assent of children; items to consider The IRB did not take into consideration the [ages] [maturity] [psychological state] of the children involved in a clinical investigation when the IRB was determining whether those children were capable of providing assent.   Specifically, ***
7363 21 CFR 50.55(f) 1 Documentation of permission by parents or guardian Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.  Specifically, ***
7372 21 CFR 56.115(b) 1 Access to records Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the FDA.  Specifically, ***
7373 21 CFR 56.109(c)(1) 1 Exception for informed consent; minimal risk study The IRB waived the requirement for a written consent form signed by the [subject] [subject's legally authorized representative], without first determining the research [presented no more than minimal risk of harm to subjects] [involved no procedure for which written consent was normally required outside the research context].  Specifically, ***
7378 21 CFR 50.27(a) 1 Copy of consent form not provided A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.  Specifically, ***
7383 21 CFR 50.25(b)(6) 1 Number of subjects in study The informed consent document did not state the approximate number of subjects involved in the study.  Specifically, ***
7386 21 CFR 50.25(b)(4) 1 Consequences of withdrawing The informed consent document did not provide information regarding the consequences of a subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject.  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, ***
7390 21 CFR 50.25(a)(4) 1 Alternate procedures, courses of treatment There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject.  Specifically, ***
7409 21 CFR 312.53(b) 1 Shipment to unauthorized persons Shipment of an investigational new drug to someone not an investigator participating in the investigation.  Specifically, ***
7483 21 CFR 312.55(b) 1 New observations, adverse effects and risks Not all participating investigators were [promptly] informed of new observations discovered by or reported to the sponsor [with respect to adverse effects and safe use].  Specifically, ***
7487 21 CFR 312.59 1 Unused drug disposition (sponsor) Failure to assure the return or other disposition of all unused supplies of an investigational drug from each individual investigator whose participation in the investigation was discontinued or terminated.  Specifically, ***
7533 21 CFR 312.69 1 Controlled substances (investigator) Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled substance. Specifically, ***
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, ***
7543 21 CFR 312.61 1 Unauthorized recipients (investigator) A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator.   Specifically, ***
7545 21 CFR 312.120(c) 1 Foreign clinical trials Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the ``Declaration of Helsinki''] [the laws and regulations of the country in which the research was conducted].  Specifically, ***
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***
7652 21 CFR 56.113 1 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, ***
7653 21 CFR 56.111(a)(1) 1 Risks minimized by using procedures already being performed The IRB approved the conduct of research, but did not determine that risks to subjects were minimized, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.  Specifically, ***
7656 21 CFR 56.108(c) 1 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, ***
7657 21 CFR 50.25(b)(5) 1 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, ***
7658 21 CFR 50.25(b)(2) 1 Termination by investigator The informed consent document did not include a statement of anticipated circumstances under which the subject's participation might be terminated by the investigator, without regard to the subject's consent.  Specifically, ***
7659 21 CFR 50.25(a)(6) 1 Compensation, medical treatment in event of injury For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained].  Specifically, ***
7664 21 CFR 50.20 1 Circumstances of obtaining consent The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence].  Specifically, ***
7692 21 CFR 56.106(e) 1 Changes in contact or chairperson information The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change.  Specifically, ***

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Biologics

Center Name Cite Id Ref No Frequency Short Description Long Description
Biologics 76 21 CFR 606.100(b 105 Maintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises]. Specifically, ***
98 21 CFR 606.100(c) 44 Thorough investigations Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications]. Specifically,***
160 21 CFR 606.160(a)(1) 26 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, ***
154 21 CFR 606.160(a)(1) 18 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, ***
155 21 CFR 606.160(b) 18 Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***
9225 21 CFR 606.171 18 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, ***
4425 21 CFR 606.60(a) 10 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, ***
15030 21 CFR 606.60(b) 8 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, ***
78 21 CFR 606.100(c) 8 Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product. Specifically, ***
94 21 CFR 606.100(b)(15) 8 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, ***
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, ***
57 21 CFR 606.60(a) 7 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, ***
67 21 CFR 606.65(e) 7 Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, ***
255 21 CFR 640.31 6 Donor suitability Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
9243 21 CFR 630.6(a) 6 Notification Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on suitability criteria]. Specifically, ***
12202 21 CFR 606.170(a) 6 Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made. Specifically,
12203 21 CFR 606.170(a) 5 Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically,
31 21 CFR 606.20(b) 5 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, ***
208 21 CFR 640.3(a)(1) 5 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, ***
35 21 CFR 606.40 4 Clean & orderly Failure to maintain facilities in a clean and orderly manner. Specifically, ***
9044 21 CFR 600.10(b) 4 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, ***
61 21 CFR 606.60(a) 3 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, ***
159 21 CFR 606.160(a)(1) 3 Legibility and indelibility Records are [illegible] [not indelible]. Specifically, ***
224 21 CFR 640.4(f) 3 Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, ***
246 21 CFR 640.25(a) 3 Storage temps./agitation Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius]. Specifically, ***
9097 21 CFR 600.15 3 Blood & Blood Components Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 °C or colder] [Cryoprecipitated AHF at -18 °C or colder] [Liquid Plasma at 1 to 10 °C] [Plasma at -18 °C or colder] [Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the labeled range] [Red Blood Cells between 1 and 10 °C] [Red Blood Cells, Frozen at -65 °C or colder] [Source Plasma at -5 °C or colder] [Source Plasma Liquid at 10 °C or colder] [Whole Blood as required]. Specifically, ***
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, ***
77 21 CFR 606.100(b) 2 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, ***
88 21 CFR 606.100(b)(9) 2 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, ***
89 21 CFR 606.100(b)(10) 2 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, ***
142 21 CFR 606.140(a) 2 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, ***
143 21 CFR 606.140(b) 2 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, ***
144 21 CFR 606.140(c) 2 Adequate identification and handling of test samples Failure to adequately provide for identification and handling of all test samples so that they are accurately related [to the specific unit of product being tested] [to its donor] [to the specific recipient]. Specifically, ***
150 21 CFR 606.151(e) 2 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, ***
158 21 CFR 606.160(e) 2 Unsuitable donors A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed. Specifically, ***
165 21 CFR 606.170(a) 2 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, ***
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, ***
205 21 CFR 640.3(f) 2 Donations in less than eight weeks A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b). Specifically, ***
207 21 CFR 640.3(a) 2 Donor suitability not performed on day of collection Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection. Specifically, ***
225 21 CFR 640.4(f) 2 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, ***
9086 21 CFR 600.14(a)(1) 2 Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports]. Specifically, ***
9087 21 CFR 600.14(a)(1) 2 Who must report - receiving information Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed biological product subject to biological product deviation reporting. Specifically, ***
9089 21 CFR 600.14(c) 2 When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***
9093 21 CFR 600.80(b) 2 Review of Adverse Experiences - SOPs There are no written procedures for the [surveillance] [receipt] [evaluation] [reporting] of post-marketing adverse experiences to FDA. Specifically, ***
9234 21 CFR 630.6(c) 2 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, ***
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, ***
9596 21 CFR 640.3(a) 2 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, ***
15036 21 CFR 610.47(a)(1)(B) 1 Notify Consignees [Collecting Establishment]
 
Failure to notify consignees to quarantine all previously collected in-date blood and blood components identified under the regulations (blood and blood components collected twelve months and less before the donor's most recent nonreactive screening tests or twelve months and less before the donor's reactive direct viral detection test) if intended for use [in another person] [for further manufacture into injectable products]. Specifically, ***
15044 21 CFR 610.47(b)(3) 1 Notify Transfusion Recipients or MD of Record [Consignee] Failure to notify [transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HCV infection] [the physician of record for transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HCV infection] of the need for recipient HCV testing and counseling. Specifically, ***
15075 21 CFR 610.46(b)(3) 1 Notify Transfusion Recips or MD of Record [Consignee] Failure to notify [transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HIV infection] [the physician of record for transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HIV infection] of the need for recipient HIV testing and counseling. Specifically, ***
38 21 CFR 606.40(b) 1 Adequate lighting, ventilation, and screening Failure to provide adequate [lighting] [ventilation] [screening of open windows and doors]. Specifically, ***
42 21 CFR 606.40(a)(2) 1 Provide space for blood withdrawal Failure to provide adequate space for the withdrawal of blood from donors with minimal [risk of contamination] [exposure to activities and equipment unrelated to blood collection]. Specifically, ***
51 21 CFR 606.40(c) 1 Provide adequate toilet facilities Failure to provide [adequate] [clean] [convenient] toilet facilities for donors and personnel. Specifically, ***
63 21 CFR 606.65 1 Safe, sanitary, orderly storage Failure to store all supplies and reagents used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner. Specifically, ***
86 21 CFR 606.100(b)(7) 1 Methods for performance of all tests The standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood components during processing. Specifically, ***
87 21 CFR 606.100(b)(8) 1 Methods for pre-transfusion testing The standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units. Specifically, ***
91 21 CFR 606.100(b)(12) 1 Criteria for suitability of reissue of returned blood The standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for reissue. Specifically, ***
93 21 CFR 606.100(b)(14) 1 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, ***
110 21 CFR 606.120(b)(2) 1 Destruction of obsolete labels Failure to destroy stocks of obsolete labels. Specifically, ***
123 21 CFR 606.121(c)(4) 1 Expiration date The container label fails to include the [expiration date, including the day, month, and year] [hour of expiration, for product less than 72 hours expiration]. Specifically, ***
129 21 CFR 606.121(c)(8) 1 Caution statement - transfusion The product is intended for transfusion and the container label fails to include the statement(s) [“Rx only”] [“See circular of information for indications, contraindications cautions, and methods of infusion.”] [“Properly identify intended recipient.”]. Specifically, ***
132 21 CFR 606.121(c)(11) 1 Caution statement - manufacturing use For products intended for manufacturing use only, the container label fails to contain the statement: "Caution: For Manufacturing Use Only". Specifically, ***
161 21 CFR 606.160(a)(2) 1 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, ***
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, ***
218 21 CFR 640.3(c)(2) 1 History of viral hepatitis - close contact An individual was used as a source of Blood who had a history of close contact within twelve months of donation with an individual having viral hepatitis. Specifically, ***
227 21 CFR 640.4(h) 1 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, ***
236 21 CFR 640.5(e) 1 Testing - inspection Failure to [visually inspect blood during storage and immediately prior to issue for] [prevent issuance of blood found to have] abnormal color, physical appearance, or indication or suspicion of microbial contamination. Specifically, ***
238 21 CFR 640.11(a) 1 General requirements - storage Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, ***
260 21 CFR 640.31(b) 1 Criteria for plasmapheresis donor suitability Failure of a plasmapheresis donor to [meet the same criteria for donor suitability as specified for Source Plasma donors (21 CFR 640.63)] [be presented the informed consent]. Specifically, ***
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, ***
295 21 CFR 640.62 1 Medical supervision Failure to have a qualified licensed physician on the premises when [donor suitability is being determined] [immunizations are being made] [whole blood is being collected] [red blood cells are being returned to donors]. Specifically, ***
333 21 CFR 640.64(e) 1 Prevention of contamination The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, ***
338 21 CFR 640.65(b)(2)(i) 1 Physician review of four month sample Failure of the physician or physician substitute to [review] [sign] the [plasma or serum protein electrophoresis data] [collection records] within 21 days after the sample was drawn. Specifically, ***
371 21 CFR 640.72(a)(3) 1 Donor consent Failure to maintain the original or a clear copy of the donor's written consent for participation in the plasmapheresis program or for immunization. Specifically, ***
3245 21 CFR 640.61 1 Explanation of hazards Failure to explain to the prospective Source Plasma donor [by a qualified physician] the [hazards of the plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor is hyperimmunized]. Specifically, ***
3455 21 CFR 601.12(f)(1) 1 Labeling changes Failure to [submit a supplement] [receive FDA approval] before distributing the product with labeling changes. 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, ***
9094 21 CFR 600.80(c) 1 Reporting Requirements Adverse experience information was not reported to FDA as required. Specifically, ***
9095 21 CFR 600.80(c)(1)(i) 1 Reporting Requirements - 15-day alert All [serious] [unexpected] adverse experiences were not reported within 15 calendar day of initial receipt of the information. Specifically, ***
9096 21 CFR 600.80(c)(1)(ii) 1 Reporting Requirements - 15-day alert follow up Regarding the follow up of [serious] [unexpected] adverse experiences, [investigations were not promptly performed] [follow-up reports containing new information were not submitted in the appropriate time frames] [there is no documentation of unsuccessful attempts to seek additional information]. Specifically, ***
9220 21 CFR 606.100(b)(20) 1 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, ***
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, ***
9261 21 CFR 610.40(a) 1 Test for communicable disease agents Failure to test each donation of human [blood] [blood components] for evidence of [HIV, type 1] [ HIV, type 2] [Hepatitis B virus] [Hepatitis C virus] [HTLV, type 1] [HTLV, type 2]. Specifically, ***
9262 21 CFR 610.40(b) 1 Approved screening tests Blood or blood components were not tested for evidence of infection due to communicable disease agents [using screening tests that the FDA has approved for such use][in accordance with the manufacturer's instructions]. Specifically, ***
9269 21 CFR 610.40(h) 1 Shipment/use of reactive units, units from deferred donors Human blood or blood components that were [reactive by a screening test] [collected from a donor with a previous record of a reactive screening test] for evidence of a communicable disease agent were [shipped] [used] without meeting the exceptions set forth at 21 CFR 610.40(h)(2). Specifically, ***
9286 21 CFR 640.16(b) 1 Sterile system Failure to ensure that all surfaces that come into contact with red cells are [sterile] [pyrogen-free]. Specifically, ***
9560 21 CFR 660.32 1 Same as for whole blood Blood for reagent red blood cells is not collected from peripheral donors as prescribed under applicable sections of the regulation for the collection of whole blood. Specifically, ***

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Human tissue for transplantation

Center Name Cite Id Ref No Frequency Short Description Long Description
Human Tissue for Transplantation 12213 21 CFR 1271.47(a) 24 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, ***
12221 21 CFR 1271.47(a) 19 Procedures for all steps Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12336 21 CFR 1271.180(a) 17 Procedures to meet core CTGP Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12230 21 CFR 1271.50(a) 15 Responsible person to determine, document The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on results of donor screening and donor testing.  Specifically, ***
12247 21 CFR 1271.55(d)(2) 13 Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, ***
12277 21 CFR 1271.75(a)(1) 12 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, ***
12286 21 CFR 1271.80(b) 11 Specimen collections not  timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, ***
12493 21 CFR 1271.90(b) 11 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, ***
12431 21 CFR 1271.265(e) 10 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, ***
12416 21 CFR 1271.260(e) 8 Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, ***
12290 21 CFR 1271.80(d)(1) 7 Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.  Specifically, ***
12492 21 CFR 1271.85(a) 7 Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents.  Specifically, ***
12229 21 CFR 1271.50(a) 6 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, ***
12351 21 CFR 1271.190(d)(1) 6 Procedures for cleaning, sanitation Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  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, ***
12301 21 CFR 1271.150(c)(1)(iii) 5 Ensurane of compliance You did not ensure that establishment(s) that  by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the initiation of the contract, agreement of arrangement] [applicable CGTP requirements after information became available that suggested the establishment was no longer in compliance].  Specifically, ***
12433 21 CFR 1271.265(f) 5 Return to inventory--procedures Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned to inventory were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, ***
12457 21 CFR 1271.320(a) 5 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, ***
12222 21 CFR 1271.47(a) 4 Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.  Specifically, ***
12239 21 CFR 1271.55(b)(2) 4 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, ***
12246 21 CFR 1271.55(d)(1)(iii) 4 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, ***
12282 21 CFR 1271.75(d) 4 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) 4 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, ***
12354 21 CFR 1271.190(d)(2) 4 Documentation of activities Documentation of facility cleaning and sanitation activities was not maintained.  Specifically, ***
12359 21 CFR 1271.195(a)(3) 4 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) 4 Monitoring-microorganisms where appropriate Environmental conditions were not monitored for microorganisms.  Specifically, ***
12398 21 CFR 1271.230(a) 4 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, ***
12411 21 CFR 1271.260(a) 4 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, ***
12429 21 CFR 1271.265(d) 4 Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.  Specifically, ***
12435 21 CFR 1271.270(a) 4 Records maintained concurrently Records were not maintained concurrently with the performance of each step.  Specifically, ***
12436 21 CFR 1271.270(a) 4 Accurate, indelible, legible Records were not [accurate] [indelible] [legible].  Specifically, ***
12223 21 CFR 1271.47(b) 3 Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
12237 21 CFR 1271.55(a)(3) 3 Summary--records used to make determination After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination.  Specifically, ***
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, ***
12272 21 CFR 1271.65(b)(2) 3 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, ***
12320 21 CFR 1271.160(b)(3) 3 Actions verified, short and long term solutions Corrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and compliance with CGTP] [did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence].  Specifically, ***
12323 21 CFR 1271.160(b)(5) 3 Monitoring systems The quality program has not established and maintained appropriate monitoring systems.  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, ***
12326 21 CFR 1271.160(c) 3 Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed.  Specifically, ***
12334 21 CFR 1271.170(c) 3 Trained or re-trained as necessary Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities.  Specifically, ***
12363 21 CFR 1271.195(c) 3 Monitoring--cross contamination, exposure to CD Environmental conditions are not monitored when such conditions could cause [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents].  Specifically, ***
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, ***
12426 21 CFR 1271.265(c)(2) 3 Improperly released for distribution HCT/Ps that were [in quarantine] [contaminated] [recovered from a donor determined to be ineligible] [recovered from a donor for whom a donor eligibility determination has not been completed] [determined to not meet release criteria designed to prevent communicable disease transmission] were 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, ***
12447 21 CFR 1271.290(b) 3 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, ****
12232 21 CFR 1271.50(b)(2) 2 Donor testing not negative for CD agents Donor testing of HCT/P donors considered eligible was not negative  or nonreactive for relevant communicable disease agents.  Specifically, ***
12236 21 CFR 1271.55(a)(2) 2 Eligibility statement--basis of determination After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been determined to be eligible or ineligible, based on the results of screening and testing.  Specifically, ***
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, ***
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, ***
12311 21 CFR 1271.160(b)(1) 2 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, ***
12322 21 CFR 1271.160(b)(4) 2 Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, ***
12329 21 CFR 1271.160(d) 2 Documentation/approval prior to implementation Computer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation.  Specifically, ***
12338 21 CFR 1271.180(b) 2 Review and approval-responsible person Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, ***
12356 21 CFR 1271.195(a) 2 Adequate control, proper conditions Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for operations were not provided].  Specifically, ***
12369 21 CFR 1271.200(b) 2 Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  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, ***
12371 21 CFR 1271.200(a) 2 Cleaned, sanitized per established schedules Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained]  according to established schedules.  Specifically, ***
12372 21 CFR 1271.200(c) 2 Calibrated per established schedules Equipment used for [inspection] [measuring] [testing] was not calibrated  according to established schedules.  Specifically, ***
12375 21 CFR 1271.210(a) 2 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, ***
12387 21 CFR 1271.220(a) 2 Causing contamination, increasing risks HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during processing] [that does not increase the risk of introduction, transmission, or spread of communicable disease].  Specifically, ***
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, ***
12453 21 CFR 1271.290(e) 2 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, ***
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, ***
12494 21 CFR 1271.85(c) 2 Reproductive cells or tissues Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for communicable diseases of the genitourinary tract.  Specifically, ***
12496 21 CFR 1271.85(b)(2) 2 SOP for release; reactive for CMV A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically. ***
15020 21 CFR 1271.200(e) 2 Documentation of maintenance and cleaning Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.  Specifically, ***
15026 21 CFR 1271.85(c) 2 Reproductive cells or tissues-cell-associated CD Donors of viable, leukocyte-rich reproductive cells or tissues were not tested for cell-associated communicable diseases or cytomegalovirus (CMV).  Specifically, ***
12224 21 CFR 1271.47(c) 1 Availability of procedures Donor eligibility procedures were not available to personnel in the area where operations are performed, or in a nearby area when such availability is impractical. Specifically, ***
12225 21 CFR 1271.47(d) 1 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) 1 Donor screening standards Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk factors for infection due to communicable disease agents] [clinical evidence of infection due to communicable disease agents] [risk factors associated with xenotransplantation].  Specifically, ***
12241 21 CFR 1271.55(b)(4) 1 Reasons for ineligibility on summary The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the  ineligibility.  Specifically, ***
12243 21 CFR 1271.55(d)(1) 1 Documentation maintained (general) Documentation was not maintained after the donor-eligibility determination was complete.  Specifically, ***
12248 21 CFR 1271.55(d)(2) 1 Information, English or translated-authenticity Information on [the identity] [the relevant medical records] of donors of HCT/Ps were [not in English] [not retained and translated to English] [not accompanied by a statement of authenticity by the translator that specifically identifies the translated document].  Specifically, ***
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, ***
12271 21 CFR 1271.65(b)(2) 1 Prominently labeled (limited use) HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled.  Specifically, ***
12278 21 CFR 1271.75(a)(2) 1 Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation.  Specifically, ***
12285 21 CFR 1271.80(a) 1 Birth mother sample not tested A sample from the birth mother of a donor one month of age or younger was not used for testing of communicable disease agents.  Specifically, ***
12309 21 CFR 1271.160(a) 1 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, ***
12310 21 CFR 1271.160(a) 1 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, ***
12319 21 CFR 1271.160(b)(3) 1 Actions taken and documented The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented].  Specifically, ***
12321 21 CFR 1271.160(b)(3) 1 Problem description, disposition, date et. al. Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the nature of the problem] [the description of the corrective action] [the date of the corrective action].  Specifically, ***
12332 21 CFR 1271.170(b) 1 Qualifications lacking Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.  Specifically, ***
12339 21 CFR 1271.180(c) 1 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, ***
12340 21 CFR 1271.180(d) 1 Adopted from another organization Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations].  Specifically, ***
12342 21 CFR 1271.190(a) 1 Size, construction, location--prevent mix-ups etc. Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups].  Specifically, ***
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, ***
12345 21 CFR 1271.190(b)(1) 1 Clean, sanitary, orderly manner Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction, transmission, or spread of communicable disease.  Specifically, ***
12346 21 CFR 1271.190(b)(2) 1 Sewage, trash removal Removal of [sewage] [trash or other refuse] was not done in a timely, safe and sanitary manner.  Specifically, ***
12349 21 CFR 1271.190(c) 1 Control system Operations were not controlled with a system [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] to prevent [improper labeling] [mix-ups] [contamination] [cross contamination] [accidental exposure of HCT/Ps to communicable disease agents].  Specifically, ***
12357 21 CFR 1271.195(a)(1) 1 Temperature and humidity controls Environmental controls do not provide for adequate control of [temperature] [humidity].  Specifically, ***
12358 21 CFR 1271.195(a)(2) 1 Ventilation and air filtration controls Environmental controls do not provide for adequate [ventilation] [air filtration].  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, ***
12390 21 CFR 1271.220(c) 1 In-process HCT/Ps-control In-process HCT/Ps were not controlled until [required inspections, tests, or other verification activities were completed] [necessary approvals were received and documented].  Specifically, ***
12391 21 CFR 1271.220(c) 1 Sampling representative (in-process HCT/Ps) Sampling of in-process HCT/Ps was not representative of the material to be evaluated.  Specifically, ***
12399 21 CFR 1271.230(a) 1 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, ***
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, ***
12414 21 CFR 1271.260(d) 1 Corrective actions Corrective actions were not [performed] [documented] when proper storage conditions were not met.  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, ***
12417 21 CFR 1271.260(e) 1 Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.  Specifically, ***
12419 21 CFR 1271.265(a) 1 Evaluation--microorganisms, damage Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination].  Specifically, ***
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, ***
12425 21 CFR 1271.265(c)(1) 1 Release of HCT/Ps by responsible person A  responsible person did not [document] [date] the determination that an HCT/P is available for distribution.  Specifically, ***
12439 21 CFR 1271.270(b) 1 Organized to facilitate review The records management system did not maintain records to facilitate review of particular HCT/Ps history [prior to becoming available for distribution] [subsequent to release as part of a follow-up evaluation or investigation].  Specifically, ***
12452 21 CFR 1271.290(d) 1 Recording I.D. code and type of HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system to record [the distinct identification code] [the type] of each HCT/P distributed to a consignee.  Specifically, ***
12458 21 CFR 1271.320(b) 1 Designated complaint file Complaints received were not maintained in a file designated for complaints.  Specifically, ***
12459 21 CFR 1271.320(b) 1 Sufficient information to draw conclusions The complaint file [did not contain sufficient information about each complaint for proper review and evaluation] [did not include the distinct identification code of the HCT/P involved] [did not contain sufficient information for determining whether the complaint is an isolated event or represents a trend].  Specifically, ***
12461 21 CFR 1271.320(c) 1 Reportable events not investigated Complaints that represent events required to be reported to FDA were not [reviewed] [evaluated] [investigated].  Specifically, ***
12469 21 CFR 1271.350(a)(1) 1 Adverse reaction reporting to FDA Adverse reactions which involved a communicable disease related to an HCT/P made available for distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body, or necessitated medical or surgical intervention, were not reported to FDA.  Specifically, ***
12473 21 CFR 1271.350(b)(2) 1 Deviations not reported to FDA HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an establishment under contract, agreement, or arrangement with your establishment] were not reported to FDA.  Specifically, ***
12489 21 CFR 1271.90(b)(1) 1 Autologous use only--labeling HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only.  Specifically, ***

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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 55 Prevention of contamination Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps] [faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking] [culinary] water. Specifically, ***
7032 21 CFR 1250.63 21 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, ***
6560 21 CFR 1250.32(a) 13 Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***
6558 21 CFR 1250.30(d) 11 Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***
6552 21 CFR 1250.28 10 Handling to avoid contamination Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination. 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, ***
6570 21 CFR 1250.33(c) 8 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, ***
6580 21 CFR 1250.38(b) 8 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, ***
6555 21 CFR 1250.30(a) 7 Clean and free from flies, rodents, and other vermin Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin]. Specifically, ***
6564 21 CFR 1250.33(a) 6 Maintained in good repair Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair. Specifically, ***
6569 21 CFR 1250.33(b) 5 Equipment kept clean Failure to keep all equipment clean. Specifically, ***
6612 21 CFR 1250.50 4 Designed to permit ready cleaning Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***
7089 21 CFR 1250.82(d) 4 Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification. Specifically, ***
7090 21 CFR 1250.82(e) 3 Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically, ***
6549 21 CFR 1250.27- 2 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, ***
6554 21 CFR 1250.30(a) 2 Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, ***
6561 21 CFR 1250.32(b) 2 Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, ***
6563 21 CFR 1250.33(a) 2 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, ***
6572 21 CFR 1250.34 2 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof. 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, ***
7030 21 CFR 1250.62 2 Submittal of construction plans Failure to submit plans for the [construction] [major reconstruction] of sanitation facilities at servicing areas to FDA for review. Specifically, ***
7034 21 CFR 1250.65 2 Pooling Drainage at places where water or food supplies are loaded into or removed from conveyances is inadequate to prevent pooling. Specifically, ***
7041 21 CFR 1250.70(a) 2 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, ***
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, ***
7053 21 CFR 1250.75(b) 2 Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***
7055 21 CFR 1250.75(b) 2 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, ***
7081 21 CFR 1250.82(a) 2 Separate systems The potable water system is [not separate and distinct from other water systems] [used for other purposes]. Specifically, ***
6567 21 CFR 1250.33(b) 1 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, ***
6579 21 CFR 1250.38(a) 1 Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***
6582 21 CFR 1250.38(c) 1 Maintained in clean condition Failure to maintain toilet rooms in a clean condition. Specifically, ***
6585 21 CFR 1250.39 1 Containers - close-fitting covers Garbage containers lack close-fitting covers. Specifically, ***
6590 21 CFR 1250.42(a) 1 Complete and closed A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically, ***
6591 21 CFR 1250.42(a) 1 Backflow protection A water system not protected against backflow. Specifically, ***
7038 21 CFR 1250.67 1 Signs for non-potable water Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking. Specifically, ***
7051 21 CFR 1250.75(a) 1 Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. 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, ***
7087 21 CFR 1250.82(c) 1 Potable water tanks -- openings A potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating substances. Specifically, ***

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Radiological health

Center Name Cite Id Ref No Frequency Short Description Long Description
Radiological health 5007 21 CFR 1002.13 11 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one.  Specifically, ***
5203 21 CFR 1040.10(h)(2)(i) 6 Reproduction of affixed information The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets] [descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation] [the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to be affixed to the product. Specifically, ***
5700 21 CFR 1002.10 6 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, ***
5032 21 CFR 1010.2(b) 4 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, ***
5031 21 CFR 1010.2(a) 3 Lack of certification of conformance Failure to furnish to the [dealer] [distributor], at the time of delivery of a product, a certification that the product conforms to all applicable standards.  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, ***
5008 21 CFR 1002.20(a) 2 Failure to report You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you. involving a product introduced or intended to be introduced into commerce by you.  Specifically, ***
5012 21 CFR 1003.10(a) 2 FDA not notified of defect or noncompliance You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled] [imported] [distributed].  Specifically, ***
5042 21 CFR 1010.3(a) 2 ID label or tag An identification 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, ***
5173 21 CFR 1040.10(g)(5)(i) 2 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, ***
5189 21 CFR 1040.10(g)(7)(v) 2 DIPH label wording - Class IV Labels regarding Class IV 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: "DANGER --- Laser radiation when open and interlock defeated.  AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION."] were not provided for defeatably interlocked protective housings. Specifically, ***
5202 21 CFR 1040.10(h)(1)(vi) 2 50 mm classification warning The following warning was not included in the user information: "CAUTION --- The use of optical instruments with this product will increase eye hazard", when use of a 50 millimeter diameter aperture stop in a laser product classified with a 7 millimeter diameter aperture stop resulted in a higher classification of the product.  Specifically, ***
5207 21 CFR 1040.11(a)(1) 2 Med. laser compliance, measurement The medical laser product [fails to comply with all of the applicable requirements of Sec. 1040.10 for laser products of its class.] [does not incorporate in each Class III or IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body, having an error in measurement of no more than 20% when calibrated in accordance with the CFR requirements]. Specifically, ***
5209 21 CFR 1040.11(a)(3) 2 Aperture label A label bearing the wording: "Laser aperture". is not affixed to the medical laser product, in close proximity to the aperture through which was emitted accessible laser radiation in excess of the accessible emission limits of Class I. Specifically, ***
5670 21 CFR 1040.10(h)(2)(ii) 2 Reproductions of warnings Adequate instructions for service adjustments and service procedures  were not provided or caused to be provided for each laser model, including legible reproductions of required labels and hazard warnings. Specifically, ***
5715 21 CFR 1002.41(a)(1) 2 Forwarding, holding, preserving distribution data You have not [immediately] forwarded to the manufacturer all of the distribution information which you have collected pursuant to 21 CFR 1002.40, nor have you elected (in writing to the manufacturer) to hold and preserve that information.  Specifically, ***
5802 21 CFR 1002.13 2 Lack of required elements An annual report which you submitted did not [summarize the contents of the records required by 21 CFR 1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period ending on June 30 preceding the due date of the report]. Specifically, ***
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, ***
5013 21 CFR 1003.10(b) 1 Dealers, distributors, purchasers not notified You did not notify [all of] the [dealers] [distributors] [purchasers] [subsequent transferees] of an electronic product which [was defective] [failed to comply with an applicable Federal standard] .  Specifically, ***
5019 21 CFR 1004.1 1 CAP not submitted In a situation where an electronic product you have manufactured [fails to comply with an applicable Federal standard] [has a defect subject to the notification requirements of 21 CFR 1003.10(b)], you have not submitted a plan to the Secretary to [bring the product into conformity with the standard] [remedy the defect] without charge (including reimbursement of any transportation expenses), replace the product with a like or equivalent one which [complies with the standard] [is free of defects relating to safety of its use], or refund the cost of the product to the purchaser.  Specifically, ***
 
5034 21 CFR 1010.2(c) 1 Certification not based on adequate test/testing program Certification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices].  Specifically, ***
5043 21 CFR 1010.3(a)(1) 1 ID label lacks name and address An identification label failed to provide the name and address of the [manufacturer] [individual or company under whose name the product was sold].  Specifically, ***
5044 21 CFR 1010.3(a)(2) 1 ID label lacks place, month & year of manufacture An identification label fails to provide the [place] [month] [year] of manufacture.  Specifically, ***
5099 21 CFR 1020.40(c)(8)(i) 1 Warning labels for controls A cabinet x-ray system lacks a clearly legible and visible label, permanently affixed or inscribed at the location of each control which can be used to initiate x-ray production, bearing the statement: "Caution: X-Rays Produced When Energized."  Specifically, ***
5142 21 CFR 1040.10(e)(2) 1 Compliance test conditions Testing for compliance was not done during operation, maintenance, or service [under those conditions and procedures which maximize the accessible emission levels, including start-up, stabilized emission, and shut-down of the laser product] [with all controls and adjustments listed in the operation, maintenance, and service instructions adjusted in combination to result in the maximum accessible emission level of radiation] [at points in space to which human access is possible in the product configuration which is necessary to determine compliance with each requirement] [with the measuring instrument detector so positioned and so oriented with respect to the laser product as to result in the maximum detection of radiation by the instrument] [for a laser product other than a laser system, with the laser coupled to that type of laser energy source which is specified as compatible by the laser product manufacturer and which produces the maximum emission level of accessible radiation from that product]. Specifically, ***
5143 21 CFR 1040.10(f)(1) 1 Protective housing Each laser product is not provided with a protective housing that prevents human access during operations to laser and collateral radiation that exceeds the limits of Class I and table VI, respectively, wherever and whenever such human access is not necessary for the product to perform its intended function(s).  Specifically, ***
5144 21 CFR 1040.10(f)(2)(i) 1 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, ***
5168 21 CFR 1040.10(g)(2)(i) 1 Class IIIa "Caution" label Each Class IIIa laser product with an  irradiance less than or equal to 2.5x10-3 W cm2 does not have affixed a label [bearing the warning logotype specified in the regulation] [the wording "LASER RADIATION --- DO NOT STARE INTO BEAM OR VIEW DIRECTLY  WITH OPTICAL INSTRUMENTS" in the position specified by the regulation] [the wording  "CLASS IIIa LASER PRODUCT" in the position specified in the regulation].  Specifically, ***
5171 21 CFR 1040.10(g)(3) 1 Class IV "Danger" label Each Class IV laser product does not have affixed a label  [bearing the DANGER logotype specified in the regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER PRODUCT" in the position specified in the regulation].  Specifically, ***
5174 21 CFR 1040.10(g)(5)(ii) 1 Aperture label wording - collateral EM radiation The following label on the laser product was not affixed in close proximity to each aperture through which is emitted accessible collateral radiation in excess of the accessible emission limits of Class I and table VI of Section 1040.10(d): "AVOID EXPOSURE --- Hazardous electromagnetic radiation is emitted from this aperture".  Specifically, ***
5181 21 CFR 1040.10(g)(6)(v) 1 NIPH label wording - Class IV Labels for Class IV accessible laser radiation which [are visible on the protective housing prior to displacement or removal of such portions of the protective housing] [are visible on the product in close proximity to the opening created by removal or displacement of such portions of the protective housing] [include the wording: "DANGER --- Laser radiation when open.  AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION."] were not provided  for noninterlocked 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, ***
5197 21 CFR 1040.10(h)(1)(i) 1 User information, adequate instructions Adequate instructions for each laser product were not provided or caused to be provided for [assembly] [operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits specified in the regulations] [a maintenance schedule  necessary  to keep the product in compliance with the standard].  Specifically, ***
5199 21 CFR 1040.10(h)(1)(iii) 1 Legible reproductions Legible reproductions of all labels and hazard warnings required by the regulations [were not affixed to the laser product] [were not provided with the laser product] [did not  include the information required for positions 1, 2, and 3 of the logotype specified in the CFR]. 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, ***
5208 21 CFR 1040.11(a)(2) 1 Calibration of measurement system The Class [III] [IV] medical laser product is not supplied with instructions specifying a procedure and schedule for calibration of the measurement system.  Specifically, ***
5244 21 CFR 1040.20(f) 1 Test deficiencies The certification tests [did not account for all errors and statistical uncertainties in the process] [did not account for changes in radiation emission or degradation in radiation safety with the age of the product].  [Failure to make measurements for certification purposes under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer.]  [Failure to position the measuring instrument at the recommended exposure position and so oriented as to result in  the maximum detection of the radiation by the instrument.]  Specifically, ***
5472 21 CFR 1020.30(k) 1 Compliance measurements--diagnostic source assembly Compliance for radiation leakage from the diagnostic source assembly was not determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.  Specifically, ***
5687 21 CFR 1002.10(j) 1 Warning signs, labels, instructions A product report did not describe for each model all [warning signs] [labels] [instructions for installation, operation, and use] that relate to electronic product radiation safety.  Specifically, ***
5688 21 CFR 1002.10(i) 1 Results of testing and quality control procedures A product report did not provide sufficient  results of testing, measuring, and quality control procedures to enable FDA to determine the effectiveness of those methods and 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, ***
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, ***
5812 21 CFR 1002.30(a)(2) 1 Results of tests You have not [established] [maintained] records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation.  Specifically, ***
5904 21 CFR 1020.30(c) 1 Assembly instructions of components adequate The manufacturer's assembly instructions were not [provided] [adequate to assure compliance] for components installed into a diagnostic x-ray system.  Specifically, ***
5907 21 CFR 1020.30(d)(1) 1 Report of assembly submitted within 15 days A completed  report of assembly regarding certified components installed in a diagnostic x-ray system was not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation protection] within 15 days following the completion of the assembly.  Specifically, ***
5910 21 CFR 1020.30(h)(1)(ii) 1 Maintenance schedule (all x-ray eqpt) Manuals or instruction sheets which include a schedule of the maintenance necessary to keep the equipment in compliance with the regulations were not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost of publication and distribution].  Specifically, ***

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