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The Top 15 Biologics 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 biologics manufacturing facilities, indicating the most common issues faced by biologics 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 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014.

The number of 473s issued (146) is the lowest since FDA began keeping track of its 483 inspection data in 2006, and is the fifth consecutive year FDA has issued fewer 483s to biologics companies than the year prior.

 Number of Biologics 483s Issued by FDA Per Year

The Top 15 Biologics Deficiencies in FDA's 483 Reports

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

Regulatory CitationShort DescriptionLong DescriptionFrequency
21 CFR 606.100(b)Maintained and followedWritten 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]. 77
21 CFR 606.160(a)(1)Concurrent documentationRecords 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. 23
21 CFR 606.100(c)Thorough investigationsFailure 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]. 21
21 CFR 606.171Biological product deviation reportFailure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred]. 20
21 CFR 606.160(b)Required recordsFailure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. 16
21 CFR 606.160(a)(1)Person performing, test results, interpretationRecords 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. 16
21 CFR 606.60(a)Equipment observed, standardized, calibratedEquipment 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. 11
21 CFR 606.65(e)Following manufacturer's instructionsFailure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. 10
21 CFR 606.100(b)Written SOPs available for use by personnelFailure to make available written procedures for use by personnel in the areas where the procedures are performed. 8
21 CFR 606.100(c)Record review prior to releaseAll records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product. 8
21 CFR 606.160(a)(1)Legibility and indelibilityRecords are [illegible] [not indelible]. 8
21 CFR 606.20(b)Qualifications of responsible personnelThe 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. 7
21 CFR 606.40(a)(1)Provide space for examinationFailure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors. 7
21 CFR 606.60(b)Equipment calibration frequencyEquipment 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. 6
21 CFR 606.60(a)Maintain and clean equipmentFailure 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]. 5

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