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Search FDA 483 letters

FDA 483 letters are actually an FDA inspection closeout form called a form 483.

Read many of the public FDA 483s letters below.

Recently published 483s post FDA inspection Over 1,500 records

Manufacturer Date Record Type Location View Download

Most common FDA 483 letter observations for 2019.

Citation ID CFR Code Referenced Short Observation Description Long Observation format Frequency in 2019
110521 CFR 211.22(d)Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***215
202721 CFR 211.192Investigations of discrepancies, failuresThere 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, ***167
360321 CFR 211.160(b)Scientifically sound laboratory controlsLaboratory 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, ***145
136121 CFR 211.100(a)Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***108
121321 CFR 211.67(a)Cleaning / Sanitizing / MaintenanceEquipment 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, ***99
188321 CFR 211.165(a)Testing and release for distributionTesting 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, ***90
358521 CFR 211.110(a)Control procedures to monitor and validate performanceControl 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, ***81
145121 CFR 211.113(b)Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***79
126321 CFR 211.68(b)Computer control of master formula recordsAppropriate 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, ***73
191421 CFR 211.166(a)Lack of written stability programThere is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***67
117721 CFR 211.63Equipment Design, Size and LocationEquipment 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, ***66
121521 CFR 211.67(b)Written procedures not established/followedWritten 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, *** 65
127421 CFR 211.68(a)Calibration/Inspection/Checking not doneRoutine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***63
111221 CFR 211.25(a)Training--operations, GMPs, written proceduresEmployees 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, ***53
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring SystemAseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***52
189021 CFR 211.165(e)Test methods The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***49
200921 CFR 211.188Prepared for each batch, include complete informationBatch 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, ***46
145221 CFR 211.113(b)Validation lacking for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***42
135821 CFR 211.100(b)SOPs not followed / documentedWritten production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***40
180921 CFR 211.160(a)Following/documenting laboratory controlsEstablished [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***40
111121 CFR 211.25(a)Training , Education , Experience overallEmployees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***39
203121 CFR 211.194(a)Complete test data included in recordsLaboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***38
143521 CFR 211.42(c)(10)(v)Cleaning SystemAseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***37
900121 CFR 211.22(a)Lack of quality control unitThere is no quality control unit. Specifically, ***36
440221 CFR 211.192Written record of investigation incompleteWritten 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, ***34
438921 CFR 211.198(a)Procedures to be written and followedProcedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***32
430321 CFR 211.67(b)Written procedures fail to includeWritten 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, ***31
145021 CFR 211.113(a)Procedures for non-sterile drug productsProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***30
191221 CFR 211.166(a)Written program not followedThe written stability testing program is not followed. Specifically, ***29
439121 CFR 211.180(e)(2)Items to cover on annual reviewsWritten 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, ***29
431421 CFR 211.84(d)(2)Reports of Analysis (Components)Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***28
201221 CFR 211.188(b)Batch production and Batch Control Record RequirementsThe 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, ***27
457621 CFR 211.192No written record of investigationWritten records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, ***26
240121 CFR 211.194(a)(4)Complete Test DataLaboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***24
363221 CFR 211.170(b)Annual visual exams of drug productsReserve 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, ***24
154021 CFR 211.125(a)Strict control not exercised over labeling issuedStrict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, ***22
176721 CFR 211.137(a)Expiration date lackingDrug 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, ***22
192021 CFR 211.166(a)(3)Valid stability test methodsThe written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***22
202821 CFR 211.192Extent of discrepancy, failure investigationsInvestigations 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, ***22
241921 CFR 211.198(a)Complaint Handling ProcedureProcedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, ***22
113321 CFR 211.25(a)GMP Training FrequencyGMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***21
188521 CFR 211.165(b)Microbiological testingEach batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***21
434221 CFR 211.142(b)Storage under appropriate conditionsDrug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***21
360221 CFR 211.160(a)Deviations from laboratory control requirementsDeviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, ***20
178721 CFR 211.80(a)Procedures To Be in WritingWritten procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***19
181021 CFR 211.160(a)Lab controls established, including changesThe 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, ***18
356521 CFR 211.58Buildings not maintained in good state of repairBuildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***18
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of AEstablishment 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, ***17
18938FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contaminationYou produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically, ***16
103321 CFR 211.22(a)Authority lacking to review records, investigate errorsThe quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***15
109821 CFR 211.22(c)Approve or reject procedures or specsThe quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***15
122721 CFR 211.67(c)Cleaning/maintenance records not keptRecords are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***15
197521 CFR 211.182Written records kept in individual logsWritten records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***15
202621 CFR 211.192Quality control unit review of recordsDrug 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, ***15
354721 CFR 211.46(b)Equipment for Environmental ControlEquipment 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, ***15
361121 CFR 211.160(b)(3)Acceptance of drug productsDeterminations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, ***15
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial actionThe 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, ***15
104921 CFR 211.22(a)Approve or reject components, products The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products]. Specifically, ***14
115921 CFR 211.28(a)Clothing appropriate for duties performedClothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, ***14
144821 CFR 211.111Establishment of time limitationsTime limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***14
193221 CFR 211.167(a)Sterility/pyrogen-free testing Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements. Specifically, ***14
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestationBuildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***14
357221 CFR 211.100(b)Procedure Deviations Recorded and JustifiedDeviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***14
119421 CFR 211.42(c)Defined areas of adequate size for operationsThe [separate or defined areas] [control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***13
179021 CFR 211.80(b)Handling and Storage to Prevent ContaminationThere was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination. Specifically, ***13
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, ApprovedChanges to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***13
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***13
122021 CFR 211.67(b)(3)Cleaning SOPs/instructionsProcedures 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, ***12
127021 CFR 211.68(b)input/output verificationInput to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, *** 12
194221 CFR 211.180(e)Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. Specifically, ***12
361321 CFR 211.160(b)(4)Establishment of calibration proceduresProcedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, ***12
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with SpecsEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***12
434021 CFR 211.142Written warehousing procedures established/followedProcedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***12
1776421 CFR 212.20(e)Written QA procedures established, followedYou did not [establish] [follow] written quality assurance procedures. Specifically,***12
21377FDCA 501(a)(2)(A)Use of non-pharmaceutical grade componentsYou used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***12
183321 CFR 211.84(d)(1)Identity Testing of Each ComponentThe 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, ***11
187921 CFR 211.180(c)Records not made readily available to FDARecords 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, ***11
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-upWritten records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, ***11
18961FDCA 501(a)(2)(A)Air flow quality, higher classified areaYour facility design allowed the influx of poor quality air into a higher classified area. Specifically, ***11
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contaminationYour facilities are not adequate to ensure [the orderly handling of materials and equipment] [the prevention of mix-ups] [the prevention of contamination of equipment or product by substances, personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on product quality. Specifically, ***11
142121 CFR 211.42(c)(10)Aseptic Processing AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically,***10
189121 CFR 211.165(f)Failing drug products not rejectedDrug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***10
358321 CFR 211.110(a)Written in-process control proceduresWritten 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, ***10
430621 CFR 211.80(a)Written Procedures Not FollowedWritten procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***10
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***10
121921 CFR 211.67(b)(2)Cleaning SOPs/schedulesProcedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***9
139521 CFR 211.103Actual vs. theoretical yields not determinedActual 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, ***9
143021 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfacesAseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***9
143321 CFR 211.42(c)(10)(iii)Air SupplyAseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, ***9
184221 CFR 211.84(d)(1)Component identity verificationDrug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. Specifically,***9
194321 CFR 211.180(e)(1)Review of representative number of batchesWritten 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, ***9
202021 CFR 211.188(b)(8)Labeling Control Records and Label CopiesThe batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of labeling. Specifically, ***9
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deteriorationAn NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, ***9
1776321 CFR 212.20(d)Determination need for investigationWhen errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically, ***9
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areasThe ISO 5 classified aseptic processing areas had [difficult to clean] [particle-generating] [visibly dirty] equipment or surface. Specifically, ***9
116221 CFR 211.28(a)Protective Apparel Not WornProtective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***8
150521 CFR 211.122(d)Label storage access limited to authorized personnelAccess to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***8
192621 CFR 211.166(b)Adequate number of batches on stabilityAn 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, ***8
203321 CFR 211.194(c)Testing and standardization of standards et. al.Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions]. Specifically, ***8
357021 CFR 211.100(a)Approval and review of proceduresWritten procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit]. Specifically, ***8

It is time for it to be easy to search FDA 483s letters.

What is and FDA form 483?
FDA form 483 is used as a written notice of deficiencies found in inspections. It is a form that is used to close out a FDA inspection.

What happens after a pharmaceutical company receives a FDA form 483?
After the inspection the pharmaceutical company must respond to any observations in the FDA inspection. After the response, the FDA will then decide next steps which can vary from accepting the response or escalating the 483 towards a warning letter.

Is the order of the observations on the FDA 483 form important?
Yes, the observations are listed on a Form 483 in order of significance by the investigator. The format of any single observation begins with a statement based in a citation of law, regulation or Act and is followed by a statement of specific conditions observed during the inspection.

What are the observations that can be listed on and FDA form 483?
See the list below for the top 100 sited FDA form 483 drug inspection observations for 2019. They are listed by the citation ID, then a short observation description and then the format for the long observation description