FDA 483 - Genentech, Inc. - February 02, 2023

During an inspection from January 26 to February 2, 2023, the U.S. Food and Drug Administration issued a Form 483 to Genentech, Inc. in South San Francisco, CA. This document, issued under the Federal Food, Drug, and Cosmetic Act, details significant observations indicating potential non-compliance with standards for manufacturing drug products. Key issues highlighted include deficiencies in microbial cross-contamination control within the Glofitamab drug product Filling Line. Inspectors observed operators improperly handling sterile components, such as tubing manifolds and stoppers, and interchanging items without adequate aseptic technique, raising concerns about potential product contamination. Further observations identified inadequate programs for aseptic processing areas. Personnel monitoring practices were found deficient, as operators sanitized gloves before environmental monitoring, contrary to established procedures. The post-run filling line environmental monitoring program also failed to include sampling of direct product contact surfaces. Additionally, operators did not consistently follow proper technique for fingertip plate sampling. The inspection also revealed inadequate quality oversight of validation activities, with pharmaceutical materials stored in areas not qualified for their required ambient conditions. Finally, basic facility deficiencies were noted, including a persistent lack of hot water in hand washing facilities within the manufacturing suite restrooms. Genentech is expected to address these observations by implementing comprehensive corrective and preventive actions, providing a formal response to the FDA.