Patheon Biologics LLCMay 2, 2022

FDA 483 - Patheon Biologics LLC - May 02, 2022

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Record Details

An FDA inspection of Patheon Biologics LLC in St. Louis, MO, a drug substance manufacturer, identified three significant observations. These included deficiencies in the qualification, monitoring, and alarming of temperature-controlled storage areas for cGMP materials. Additionally, the firm was cited for inadequate labeling of cGMP materials and discrepancies between batch records/SOPs and actual manufacturing/laboratory procedures.

Company: Patheon Biologics LLC
Inspection Date: May 2, 2022
Product Type: Drugs
Office: Division of Advertising & Promotion
People: Brian Roelofs
Ian L. McWilliams
Michael R. Shanks (Investigator)

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ID · d6ce1e74-8ba4-44b4-8402-de3cf9149ba6