Microbiology FDA 483 (Contract Pharmaceuticals): Failure to thoroughly review any unexplained discrepancy
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Contract Pharmaceuticals Limited
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Specifically, your firm was notified a highly pathogenic microorganism was recovered during environmental monitoring of the production area and an incident report (IR) was not initiated to conduct a documented investigation of the result. Brucella melitensis was recovered from an air sample taken on 08/02/2022 in Wash Up Room *** where production equipment is cleaned. Firm procedure QC-250-24 Microbial Environmental Monitoring (EM) Program does not require IRS to be initiated when action levels are not reached and lacks instructions to initiate an IR for pathogenic or objectionable microbial recoveries. Quality Unit personnel approved both the2022 Environmental Monitoring Report and 2022 Environmental Monitoring Annual Trend Report which included the recovery of Brucella melitensis. The 2022 Environmental Monitoring Annual Trend Report states Brucella melitensis is considered non-objectionable, however the identification report from your third-party contract laboratory received by your Quality Unit on 08/24/2022 states the microorganism is highly pathogenic.
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FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.