FDA EIR - Genentech Inc - March 17, 2020

An FDA inspection of Genentech Inc.'s Vacaville, CA facility was conducted from March 11-17, 2020. This routine pre-approval and surveillance cGMP inspection assessed the manufacturing of biotech bulk drug substances. The regulatory framework encompassed a request through a Mutual Recognition Agreement (MRA) for Actemra IV and SC drug substances, and a Pre-License Inspection for Biologics License Application (BLA) 761170, covering Pertuzumab/Trastuzumab/Hyaluronidase. The inspection adhered to compliance programs CPGM 7356.002M and CPGM 7346.832, evaluating quality, facility and equipment, materials, and production systems. Significantly, no objectionable conditions were noted during this inspection, and consequently, a Form FDA-483 (Inspectional Observations) was not issued. The inspection included a follow-up on corrective actions for observations from the previous August 2018 inspection, which addressed issues like label reconciliation, cleaning agent documentation, and computer system controls. Discussions with firm management highlighted various items, including specific observations regarding a misalignment in preventive maintenance scheduling for equipment. No formal required actions were mandated as a result of this inspection.