FDA 483 - Patheon Biologics LLC - November 20, 2024

Patheon Biologics LLC in Saint Louis, MO, was inspected by the FDA, revealing significant issues in quality control and laboratory procedures. The inspection found failures in thoroughly investigating unexplained discrepancies and customer complaints, including issues with particulate matter and packaging integrity. Additionally, laboratory testing procedures for materials were not fully documented, specifically regarding bacterial endotoxin testing.