483
Patheon Biologics LLCPatheon Biologics LLC – FDA 483, May 2, 2022
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.
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ID · d6ce1e74-8ba4-44b4-8402-de3cf9149ba6
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