# FDA 483 - Mark Savant, M.D. - April 17, 2024

Source: https://www.keypedia.com/records/483/mark-savant-md/4720969f-32c6-4997-801c-f71f415f87d4

> FDA 483 for Mark Savant, M.D. on April 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Savant, M.D.
- Inspection Date: 2024-04-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of San Francisco Research Institute identified significant deficiencies in the conduct and supervision of an investigation by Dr. Mark J. Savant. Observations included failures to adhere to the investigational plan, improper subject enrollment, inadequate investigational product storage, and lack of personal oversight. Additionally, the firm failed to obtain proper informed consent and did not retain all required investigational records.

## Related Officers

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

Company: https://www.keypedia.com/companies/mark-savant-md/4733594e-2101-4145-a989-432bb8ede00a

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