FDA 483 - Patheon Biologics LLC - November 10, 2023

An FDA inspection of Patheon Biologics LLC, Pharma Services-Thermo Fisher Scientific in Saint Louis, MO, revealed significant deficiencies in their drug substance manufacturing operations. Observations included inadequate and unfollowed standard operating procedures, ineffective corrective and preventive action (CAPA) oversight for recurring issues, and improper labeling of cGMP materials. Additionally, issues with equipment maintenance, stability testing studies, and quality oversight of training were noted, indicating systemic control weaknesses.