FDA 483 - Patheon Italia S.p.A. - May 26, 2023

An FDA inspection of Patheon Italia S.p.A. in Monza, Italy, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring in aseptic processing, scientifically unjustified media fill designs for sterile products, and improperly qualified equipment. Additionally, the firm's warehouse lacked scientifically-driven temperature mapping studies for drug product storage.