Patheon UK Limited – FDA 483, Jul 7, 2026

An FDA inspection of Patheon UK Limited, a sterile injectable drug product manufacturer in Swindon, revealed significant deficiencies across multiple areas. The firm failed to maintain aseptic conditions during filling operations, lacked adequate Quality Unit oversight, and did not thoroughly investigate repeated out-of-specification results for its sterile products. Additionally, issues with data integrity, including unidentified chromatographic peaks and open CAPAs related to missing audit trails, were observed, indicating a severe lack of control over critical manufacturing and quality processes.