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The Top 15 Pharmaceutical Deficiencies Cited by FDA in 2014

Posted 08 December 2014 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies.

Total 483s Issued Declines for First Time in Six Years

In its most recent report, FY 2014 Inspectional Observation Summaries, FDA said it issued 645 Form 483s—forms indicating areas of noncompliance at a facility—to pharmaceutical companies in fiscal year 2014.

The number of 473s issued (645) marked the second consecutive year FDA has issued fewer pharmaceutical 483s than the year prior, and the 2014 total (645) is 19% less than its 2012 high water mark (787 inspections).

Number of 483s Issued by FDA by Year - Pharmaceutical

The Top 15 Pharmaceutical Deficiencies in FDA's 483 Reports

FDA's inspections also noted common deficiencies by pharmaceutical manufacturers.

Regulatory CitationShort DescriptionLong DescriptionFrequency
21 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]. 145
21 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. 109
21 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. 94
21 CFR 211.100(a)Absence of Written ProceduresThere 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. 87
21 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.  72
21 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]. 72
21 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. 64
21 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. 63
21 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. 54
21 CFR 211.166(a)Lack of written stability programThere is no written testing program designed to assess the stability characteristics of drug products. 51
21 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.  "51
21 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]. 47
21 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]. 46
21 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]. 43
21 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]. 43

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