Patheon Italia S.p.A. — FDA 483 Findings

Your program for the visual inspection ofsterih drug products does not provide adequate assurance that finished products manufactured at your facility possess their purported quality attributes, including that they are essentially free from particulate matter.

Quality Unit (QU) oversight over the manufacturing process is inadequate.

Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not fully established or followed.

Your rogram for the environmental control of classified areas, including critical supporting area for the Grade A Cb><-O does not provide assurance ofyour ability to adequately clean and/or disinfect your classified areas and detect levels oftheir microbial contamination.

Failure to establish process controls and testing designed to assure that the drug products you manufacture have the identity, strength, quality and purity that it purports or is represented to possess.