FDA EIR - Genentech, Inc. - May 21, 2021

A pre-approval inspection of Genentech, Inc.'s Hillsboro Technical Operations (HTO) facility in Hillsboro, OR, was conducted by the FDA from May 17 to May 21, 2021. The inspection, carried out under CPGM 7346.832M Product Inspections, focused on the manufacturing of sterile injectable drug products on a new Fill Line. The primary objective was to evaluate finished product manufacturing operations for specific sterile injectable drug products for pre-market approval.

During this inspection, a single observation was noted and documented in a FORM FDA 483. The main issue identified was a deficiency in the in-process control (IPC) for vial fill weight. Specifically, the inspection found that while the Fill Line's tare and gross weight scales were verified with certified weights before product filling, there were no scale-independent methods employed during vial filling, nor were there scale verifications performed at the completion of batch filling. This lack of additional verification meant there was no assurance that the vial fill weight or fill volume remained accurate throughout the entire batch or production campaign.

The report also referenced a previous surveillance inspection in 2018 which resulted in a "Voluntary Action Indicated" classification and multiple observations regarding environmental monitoring procedures, calibration SOPs, discrepancy reviews, equipment cleaning documentation, and batch record completeness. However, for the current 2021 inspection, the focus was solely on the vial fill weight IPC deficiency.

Genentech management acknowledged the observation and stated their intention to submit a formal response to the FORM FDA 483 within 15 business days. No other significant deficiencies were detected during this pre-approval inspection.