FDA 483 - Patheon Biologics LLC - January 24, 2023

An FDA inspection of Patheon Biologics LLC, a drug substance manufacturer in Saint Louis, MO, revealed significant deficiencies across multiple areas. Observations included inadequate facility cleaning and maintenance leading to mold contamination, insufficient control of manufacturing processes, and incomplete risk assessments for viral contamination. Additionally, issues were noted with the segregation and management of expired raw materials, inadequate maintenance programs, and improper labeling of GMP materials and equipment.