FDA 483 - Patheon Biologics LLC

The FDA inspection of Patheon Biologics LLC in St. Louis, MO, identified significant deficiencies in their drug substance manufacturing operations. Issues included inadequate controls to prevent microbial contamination, insufficient monitoring of critical process parameters, and poorly defined or followed written procedures. These findings led to bioreactor contaminations, environmental control failures, and delayed responses to deviations, indicating a need for robust quality system improvements.