FDA 483 - AGC Biologics S.p.A. - November 20, 2023

An FDA inspection conducted from November 8 to November 20, 2023, at AGC Biologics S.p.A., a cell and gene therapy manufacturer in Bresso, Milan, Italy, identified critical observations related to manufacturing controls. The primary issues included a failure to investigate the root cause and implement corrective actions for repeated non-viable particulate alarms. Records indicated 19 alarms during batch production and 40 without personnel present, with the source remaining uninvestigated. The company also did not consistently adhere to its procedures for out-of-action particulate results, specifically neglecting to verify actions like removing exposed materials, checking hood air velocity, and sanitizing equipment, nor were these steps documented in batch records. Additionally, aseptic operators were observed making rapid movements and replacing gloves without required environmental monitoring, violating established behavioral protocols for sterile areas. These findings indicate non-compliance with essential Good Manufacturing Practices. AGC Biologics S.p.A. is required to provide a robust response detailing their proposed corrective and preventative actions to address these deficiencies and ensure product quality and patient safety.