FDA 483 - Patheon Italia S.p.A. - November 18, 2022

An FDA inspection of Patheon Italia S.p.A. in Monza, Italy, revealed significant deficiencies in aseptic processing, environmental monitoring, and data integrity. The firm failed to establish and follow procedures to prevent microbiological contamination of sterile drug products, lacked adequate controls for electronic data systems, and did not thoroughly investigate deviations or implement effective corrective actions. These issues indicate a high risk of product contamination and compromised data reliability.