FDA 483 - Patheon Italia S.p.A.

Patheon Italia S.p.A. in Monza, Italy, underwent an FDA inspection from August 30 to September 3, 2021, focusing on drug product manufacturing. The inspection revealed significant deficiencies in aseptic techniques and procedures for preventing microbiological contamination during sterile drug product filling operations. These issues indicate a failure to maintain adequate control over sterile manufacturing processes.