FDA 483 - AGC Biologics SPA - November 20, 2023

AGC Biologics S.p.A., a cell and gene therapy manufacturer in Bresso, Milan, Italy, was cited for significant deficiencies during an FDA inspection. Observations included a failure to investigate the root cause of repeated non-viable particulate alarms and a lack of adherence to established procedures for handling out-of-action results. Additionally, operators were observed not following aseptic area behavior and hygiene protocols, such as rapid movements and improper glove replacement.