AGC Biologics, Inc. – FDA EIR, Jul 23, 2021

AGC Biologics, Inc. underwent an FDA surveillance inspection from July 12 to July 23, 2021, focusing on its operations as a licensed biological product manufacturer. The inspection, conducted under C.P. 7345.848 for biological drug products (CBER) and as part of the Team Biologics FY’2021 Workplan, identified three significant deficiencies related to current Good Manufacturing Practices (cGMP). The primary issues included inadequate adherence to sanitization procedures, evidenced by recurring fungal contamination (yeast and mold) in manufacturing floor samples between September 2018 and December 2020. Investigations into these environmental excursions, spanning multiple deviations, indicated systemic failures in cleaning execution and maintenance. Furthermore, the company's investigations into unexplained discrepancies, such as a bioreactor dissolved oxygen reading of 0%, lacked appropriate conclusions and follow-up, with some related quality events remaining open. Lastly, written procedures for cleaning and maintaining laboratory equipment, specifically Quality Control Biological Safety Cabinets and Laminar Airflow Hoods, were found to be deficient. In response to these findings, a 3-item Form FDA-483, Inspectional Observations, was issued to AGC Biologics, Inc. The firm is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and prevent recurrence of the identified issues.