# FDA 483 - Genentech, Inc. - October 18, 2017

Source: https://www.globalkeysolutions.net/records/483/genentech-inc/10231157-3947-4a66-ba76-179c78eb0a2a

> FDA 483 for Genentech, Inc. on October 18, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2017-10-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Genentech, Inc. in Oceanside, CA, a bulk drug substance manufacturer, was cited for two observations during an FDA inspection. The inspection revealed facility deficiencies including brownish residue, rust stains, and peeling caulking in manufacturing and weighing areas. Additionally, issues were noted in the Supplier Quality Management group regarding tracking actions where the owner and quality individual were the same, leading to potential conflicts of interest in approvals and extensions.

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
- [Ashar P. Parikh](https://www.globalkeysolutions.net/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)

Company: https://www.globalkeysolutions.net/companies/genentech-inc/fc196e7f-0f5e-4ef1-afa6-3023ca6df1f3

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