FDA 483 - Patheon Inc. - February 24, 2023

An FDA inspection of Patheon Inc. - Toronto Region Operations, a contract manufacturer in Mississauga, revealed a significant issue regarding the firm's quality control laboratory. The company failed to adequately investigate unexplained discrepancies, specifically system suitability failures in HPLC analyses of drug products. Despite identifying potential root causes, the firm has not implemented effective corrective actions to address these recurring problems.