Microbiology FDA 483 (Kilitch Healthcare): Established test procedures are not documented at the time of performance
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Kilitch Healthcare India Limited
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On October 12, 2023, a microbiology manager was observed back dating entries into the “Sterility Test Sample Inward Register”. Other microbiology employees were observed writing entries into a binder containing “Recording of ***, Filling Microbiological Activity”. The binder contained incomplete records for batches that had been manufactured February-May, 2023, including US market batches ***. When these records were reviewed again on October 19, 2023, they were filled out and had been backdated. A microbiologist confirmed times recorded into the backdated records were not accurate.
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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.