# FDA 483 - Genentech, Inc. - August 11, 2023

Source: https://www.keypedia.com/records/483/genentech-inc/ce85e9f0-3331-495a-b1b4-a7e2df5fa79b

> FDA 483 for Genentech, Inc. on August 11, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2023-08-11
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Genentech, Inc. in South San Francisco, CA, identified one observation related to their role as a sponsor of a clinical study. The firm failed to notify the FDA about the termination, for cause, of a principal investigator's participation in an investigation. This indicates a lapse in regulatory reporting requirements for clinical trials.

## Related Documents

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- [483 - 2024-03-12](https://www.keypedia.com/records/483/genentech-inc/7887b305-0de6-472c-b596-8cbd94e8d300)
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- [483 - 2022-05-26](https://www.keypedia.com/records/483/genentech-inc/3b630c1e-0dc5-44a8-a456-256f25c6a163)

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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

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