FDA 483 - AGC Biologics S.p.A. - November 20, 2026

During an inspection conducted from November 8 to November 20, 2023, the FDA identified significant observations at AGC Biologics S.p.A., a cell and gene therapy manufacturer located in Bresso, Milan, Italy. The inspection revealed critical issues related to quality system failures and adherence to aseptic manufacturing procedures. A primary concern was the company's failure to identify the root cause and implement effective corrective actions for repeated non-viable particulate alarms in critical cleanroom areas, with 19 alarms during production and 40 without personnel, none adequately investigated. Furthermore, the company did not consistently follow its own procedures for addressing out-of-action particulate results, failing to verify or document required actions like material removal and sanitization. Additional observations highlighted procedural deviations by operators in aseptic processing areas, including rapid movements during sterile filtration and filling, contrary to established protocols, and replacing gloves without performing environmental monitoring. These observations, documented on an FDA Form 483, indicate deficiencies in maintaining a state of control and compliance with Good Manufacturing Practices. AGC Biologics S.p.A. is required to provide a comprehensive response detailing its corrective and preventive actions to address these findings and prevent recurrence.