FDA 483 - Genentech, Inc.

During an inspection from May 17-21, 2021, the FDA observed that Genentech, Inc. in Hillsboro, OR, lacked adequate control procedures for monitoring manufacturing processes. Specifically, the firm failed to establish controls to address variability in the fill volume of drug product vials, including during vial filling and at batch completion. This indicates a significant concern regarding the quality control of their pharmaceutical manufacturing operations.