Genentech, Inc.March 12, 2024

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

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Record Details

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.

Company: Genentech, Inc.
Inspection Date: March 12, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
Person: Dustin R. Abaonza (investigator)

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ID · 7887b305-0de6-472c-b596-8cbd94e8d300