Genentech, Inc. – FDA EIR, Sep 16, 2016

This FDA Center for Drug Evaluation and Research (CDER) inspection of Genentech, Inc., conducted from September 12-16, 2016, focused on data verification for Biological License Application (BLA) 761053 for ocrelizumab, specifically covering sponsor responsibilities for two multiple sclerosis clinical protocols (WA20193 and WA25046). The inspection was performed under the Bioresearch Monitoring (BIMO) Compliance Program, examining aspects such as investigator selection and monitoring, quality assurance, safety reporting, and data handling. During this inspection, the FDA found no reportable deficiencies or issues with Genentech's overall operations and consequently, no FDA-483 Inspectional Observations were issued, indicating a 'No Action Indicated' classification. However, the report detailed comprehensive actions taken by Genentech regarding a clinical investigator site in Bosnia for Protocol WA20193. The sponsor identified this site as seriously non-compliant with Good Clinical Practice (GCP) and protocol requirements, citing issues such as incorrect pregnancy testing, falsification of source documents, and inadequate investigator oversight, which compromised patient safety and data integrity. Genentech promptly initiated site closure, conducted a 'For Cause Audit', assessed the statistical impact of the compromised data (finding no meaningful effect on primary endpoints), and notified relevant health authorities. These proactive internal corrective actions by the sponsor demonstrated robust oversight, despite the identified site-specific misconduct.