FDA 483 - Patheon Biologics LLC - March 02, 2023

Patheon Biologics LLC in St. Louis, MO, was inspected and received a Form 483 with four observations. The inspection revealed significant issues with data integrity in laboratory control records, inadequate investigations into deviations and out-of-specification results, scientifically unsound specifications for raw materials, and deficiencies in equipment design and maintenance for contamination control. These findings indicate a need for improved quality system controls and adherence to cGMP requirements.