# FDA EIR - Genentech, Inc. - June 27, 2012

Source: https://www.keypedia.com/records/eir/genentech-inc/7baeebcf-4af5-4b43-9d67-8a262c4ee8b8

> FDA EIR for Genentech, Inc. on June 27, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Genentech, Inc.
- Inspection Date: 2012-06-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Genentech, Inc.'s Hillsboro, OR facility was conducted from June 19-27, 2012. This pre-approval inspection focused on the drug product manufacturing area, quality control laboratories, and warehouse operations, specifically for certain drug products. The inspection followed regulatory guidelines for therapeutic drug products and pre-approval investigations.
The inspection identified nine significant observations, documented on a Form FDA 483. Key issues included a lack of environmental monitoring for non-viable particles and air velocity in vial filling lines, absence of a predetermined HEPA filter replacement schedule, and inadequate assurance regarding the suitability of compressed air for vial drying. Furthermore, the automated visual inspection machines lacked appropriate validation schedules, and the adequacy of their challenge kits could not be verified. Deficiencies were also noted in the electronic document management system (EDMS) regarding validation of current GMP documents, and sampling procedures lacked clear descriptions of random sampling. The operation and cleaning procedures for an inspection machine were found inadequate. A recurring concern was the attribution of multiple discrepancies to "human error" without corresponding recommendations for retraining, highlighting a systemic issue in corrective actions. Genentech is required to address these observations through comprehensive corrective and preventive actions.

## Related Documents

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Company: https://www.keypedia.com/companies/genentech-inc/97918967-ab2f-4019-9954-a0d687852d27

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6