FDA 483 - Patheon Pharmaceuticals Inc. - September 26, 2025

Patheon Pharmaceuticals Inc. in Cincinnati, OH, was cited for significant deficiencies in its quality control systems during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and implement corrective actions, and lacked written procedures for equipment cleaning and maintenance. Additionally, the quality control unit did not consistently follow its own procedures, leading to numerous overdue deviations and repeated issues, indicating a systemic breakdown in ensuring product quality.