Catalent Pharma Solutions, LLCJanuary 11, 2023

FDA 483 - Catalent Pharma Solutions, LLC - January 11, 2023

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Record Details

An FDA inspection of Catalent Pharma Solutions LLC in Winchester, KY, revealed significant deficiencies in laboratory record review processes. The firm failed to ensure a second person reviewed original records for accuracy, impacting both microbial plate counts and raw material identity testing data. These lapses indicate a serious concern regarding data integrity and quality control within the manufacturing process.

Company: Catalent Pharma Solutions, LLC
Inspection Date: January 11, 2023
Product Type: Drugs
Office: Cincinnati District Office
People: Wen Ning Chan (Mathematical statistician)
Logan T. Williams (Investigator )

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ID · ea296a40-d7a3-4254-8f00-4c9ad8e69edf