Pharmalogic Cincinnati, LLCDecember 8, 2023

FDA 483 - Pharmalogic Cincinnati, LLC - December 08, 2023

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Record Details

Pharmalogic Cincinnati, LLC, a PET manufacturer, was inspected by the FDA. The inspection revealed a significant deficiency in their quality system, specifically regarding master production and control records. The firm's master batch records lacked complete production and control instructions, including critical process parameters for mixing.

Company: Pharmalogic Cincinnati, LLC
Inspection Date: December 8, 2023
Product Type: Drugs
Office: Cincinnati District Office
People: Lisa R. Hilliard (Consumer Safety Officer , Investigator)
Wen Ning Chan (Mathematical statistician)

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ID · 40c1172a-a4e1-42c1-b66c-2b36a14953bd