FDA 483 - AGC Biologics, Inc. - July 12, 2021

An FDA inspection of AGC Biologics, Inc. in Bothell, WA, revealed significant deficiencies across three observations. The firm failed to consistently follow and maintain effective sanitization procedures, leading to fungal contamination trends. Additionally, investigations into unexplained discrepancies and batch failures were found to be incomplete, lacking definitive root causes and adequate follow-up actions.