FDA 483 - Patheon Manufacturing Services LLC - September 26, 2025

An FDA inspection conducted from September 22-26, 2025, at Patheon Manufacturing Services LLC in Greenville, NC, a drug contract manufacturer, revealed significant concerns regarding manufacturing equipment and process controls. The primary observation noted that equipment used in drug product manufacturing lacked appropriate design and adequate controls to facilitate its intended use, cleaning, and maintenance. Specifically, the firm failed to establish robust controls for Process Analytical Technology (PAT) system modifications and validation procedures for its spectroscopy system, critical for continuous tablet manufacturing. This deficiency was highlighted when a process performance qualification (PPQ) batch was aborted due to out-of-limits predictions. The company's subsequent investigation identified several critical shortcomings, including inadequate model validation following vendor repairs, insufficient post-repair validation procedures, unauthorized changes to acceptance criteria, and a lack of proper change control for system modifications, alongside ongoing system deficiencies. These observations indicate deviations from regulatory expectations for ensuring drug product quality and safety, aligning with requirements under the Federal Food, Drug, and Cosmetic Act. Patheon Manufacturing Services LLC is expected to promptly address these findings by implementing comprehensive corrective and preventative actions to bring their equipment and control systems into full compliance with regulatory standards.