FDA 483 - Patheon Italia S.p.A - February 10, 2025

An FDA inspection of Thermo Fisher Scientific (Patheon Italia S.p.A.) in Ferentino, Italy, revealed significant deficiencies in quality unit oversight, process controls, and aseptic manufacturing practices. The firm failed to adequately manage investigations, validate critical processes, ensure sterility, and maintain effective visual inspection and environmental monitoring programs. These issues collectively indicate a lack of robust quality systems necessary to assure drug product quality and purity.