Microbiology FDA 483 (Eugia SEZ): Procedures not followed for Enumeration of Microbial Colonies
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Eugia SEZ Private Limited
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Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring plates, one plate for employee number *** for Finger Dab Right Hand, was observed to have one colony. The action level for this sample is *** CFU. This plate had been read by both the analyst and reviewer and documented as “Nil” on the “Personal Monitoring Data Sheet For: *** Q1-24 -Feb 13, 2024”.
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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.