Genentech, Inc. – FDA 483, Sep 27, 2011

This FDA Form 483 was issued to Genentech Inc., a manufacturer located at 1 DNA Way, South San Francisco, CA, following an inspection from September 2 to September 27, 2011. The report was addressed to Andrea J. Goddard, Senior Director and SSF Site Quality Head.

The inspection revealed four observations:

1. **Inadequate Investigation Records (Repeat Observation):** Written records of investigations into discrepancies and batch failures lacked conclusions and follow-up. * Deviation Report #506273 (disintegrating gaskets on vial washer) failed to include comparison of particulates from culled Avastin vials with the gasket material to rule out contamination of a quarantined lot. * Deviation Report #464179 (capper power outage) failed to describe actions taken for a capper oil leak and disposition of in-process vials, lacking assurance of repair before resuming manufacturing or proper discard of vials.

2. **Inappropriate Equipment Design:** Equipment used in manufacturing was not of appropriate design for its intended use. * No data assures Avastin vial conveyance and capping occurs in a "Controlled Primary HEPA filtered Area" as described in BLA #125085. A gap in the capping area's HEPA filter coverage appeared to allow influx of Class [redacted] air. * Lack of adequate documented evidence to