AGC Biologics, Inc. – FDA EIR, Oct 15, 2018

An FDA cGMP surveillance inspection of CMC ICOS Biologics, Inc dba AGC Biologics, a biological drug product manufacturer in Bothell, WA, took place from October 4 to October 15, 2018. Conducted under established biological drug product inspection guidelines, the inspection revealed four primary areas of concern impacting compliance with regulatory standards. Significant issues included inconsistent equipment, environmental, and production controls necessary to minimize contamination risks during the manufacture of drug substances via cell culture. This encompassed observations on operator aseptic technique, an insufficient environmental monitoring program, and unvalidated sanitization procedures. Furthermore, the facilities used for manufacturing intermediates and active pharmaceutical ingredients were not consistently maintained or kept clean, with specific findings noting inadequate maintenance, missed sanitization events, soiled equipment, and compromised wall surfaces. The company also failed to consistently implement corrective actions following investigations into deviations and out-of-specification results, including instances where critical deviations lacked a corrective and preventive action plan. Finally, electronic records within the production and laboratory control systems did not meet regulatory expectations for trustworthiness and reliability. This included concerns about the availability of original data, traceability of various GMP records, retention of raw data, and the absence of routine audit trail reviews. Following the inspection, a Form FDA 483 detailing these observations was issued. Company management acknowledged the findings and committed to providing a formal response to the Agency within 15 days, outlining their plans for addressing these deficiencies.