Patheon Inc.February 17, 2023

FDA 483 - Patheon Inc. - February 17, 2023

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Record Details

Patheon Inc., a contract manufacturer in Whitby, was cited for inadequate testing and release procedures for drug products. The firm failed to perform appropriate laboratory determination of identity and strength for active ingredients, specifically for a drug substance used in tablets distributed to the US market, by not conducting full testing per the supplier's Certificate of Analysis.

Company: Patheon Inc.
Inspection Date: February 17, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Michele Gottshall
Truong X. Nguyen (Investigator)

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ID · f9bce56c-ec13-47fb-acac-4981f4b62426