# FDA 483 - Genentech, Inc. - September 27, 2011

Source: https://www.keypedia.com/records/483/genentech-inc/18f90c1b-4f69-4c48-99f7-a22fc019324c

> FDA 483 for Genentech, Inc. on September 27, 2011. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2011-09-27
- Office Name: San Francisco District Office
- Summary: 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

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Company: https://www.keypedia.com/companies/genentech-inc/709aa262-e8df-42fa-bec6-02673e7f52ec

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df