FDA 483 - Patheon Biologics LLC - May 02, 2022

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.