# FDA 483 - Genentech, Inc. - March 12, 2024

Source: https://www.globalkeysolutions.net/records/483/genentech-inc/7887b305-0de6-472c-b596-8cbd94e8d300

> FDA 483 for Genentech, Inc. on March 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2024-03-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Genentech, Inc. in South San Francisco, CA, was inspected as a sponsor of investigational drugs, revealing significant deficiencies. The firm failed to maintain adequate records for returned investigational medical products and ensure proper GCP training for decentralized study staff. Additionally, the company was cited for late submission of required safety reports to investigators.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b