FDA 483 - Patheon Italia S.p.A. - September 29, 2023

An FDA inspection of Patheon Italia S.p.A., a biological drug manufacturer in Monza, Italy, identified a significant issue with adherence to established warehousing procedures. The firm failed to follow its written SOP for tracking the storage and movement of materials, leading to discrepancies between inventory records and physical stock in dispensing and storage areas. This indicates a breakdown in material control and record-keeping practices.