FDA 483 - ACS Dobfar SPA (Plant #2) - July 18, 2017

An FDA inspection of ACS Dobfar s.p.a. (Plant #2) in Milan, Italy, revealed significant deficiencies in their drug manufacturing processes. Observations included a lack of adequate process validation for drug products, insufficient controls to prevent cross-contamination, and failures in procedures designed to prevent microbiological contamination of sterile drug products. These issues indicate a high potential for product quality and safety concerns.