FDA 483 - Chiesi Farmaceutici S.p.A. - March 28, 2025

An FDA inspection of Chiesi Farmaceutici S.p.A. in Parma, Italy, revealed significant deficiencies in quality control. Observations included inadequate visual inspection procedures and operator qualification, insufficient acceptance criteria for biological indicators in sterilization, and compromised drug product system integrity due to observed droplets. These issues collectively point to a heightened risk of product quality and sterility concerns.