FDA 483 - Patheon Biologics LLC - December 08, 2023

An FDA inspection of Patheon Biologics, LLC in St. Louis, MO, revealed significant deficiencies in deviation investigations, environmental controls, and facility maintenance. The firm failed to thoroughly investigate leaks in production suites for potential microbial growth and lacked adequate documentation and tracking for environmental monitoring. Additionally, the facility exhibited poor maintenance with cracks in ceilings and visible residue buildup in production areas and hallways.