FDA 483 - Chiesi Farmaceutici S.p.A. - April 11, 2023

Chiesi Farmaceutici S.p.A. in Parma, Italy, a drug product manufacturer, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate validation of aseptic processes, failure to establish and follow procedures to prevent microbiological contamination, and insufficient laboratory controls for analytical method validation. Additionally, the quality unit lacked responsibility for contract testing oversight and failed to ensure the reliability of supplier's reports of analysis.