Genentech, Inc. – FDA EIR, Oct 7, 2022

An FDA inspection of Genentech Inc. (South San Francisco, CA) conducted from March 4-12, 2024, identified three significant observations. This high-priority surveillance inspection, conducted under compliance program 7348.810 for Sponsors and Contract Research Organizations, revealed a lack of adequate records for the receipt and disposition of investigational drugs, including returned product from investigator sites and incomplete disposition logs. Furthermore, Genentech failed to ensure proper study monitoring, specifically noting that decentralized staff lacked the required Good Clinical Practice (GCP) training. Lastly, the company did not provide all participating investigators with timely written Investigational New Drug (IND) safety reports. The recommended classification for this inspection was Voluntary Action Indicated (VAI).

An earlier inspection from August 7-11, 2023, also resulted in a VAI classification, citing Genentech for failing to notify the FDA about the termination of an investigator's participation in a study for cause. Prior inspections, such as one from September 29-October 7, 2022, concluded with no significant observations (No Action Indicated). Genentech is expected to formally respond and implement corrective actions to address the identified deficiencies to ensure compliance with the Federal Food, Drug, and Cosmetic Act.