# FDA 483 - Amit G. Shah, MD - April 02, 2026

Source: https://www.keypedia.com/records/483/amit-g-shah-md/254d3e6d-c758-4721-895c-1be77342b635

> FDA 483 for Amit G. Shah, MD on April 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amit G. Shah, MD
- Inspection Date: 2026-04-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Amit G. Shah, MD, a clinical investigator in Fort Mill, SC, revealed two significant observations related to the timely reporting of adverse events. The firm failed to promptly report both serious and non-serious adverse events to the study sponsor, as required by the study protocol. These findings indicate deficiencies in adherence to clinical trial reporting requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-grace/023993d4-63ef-40ba-a538-42479b65011c)
- [Peyton L. Sloan](https://www.keypedia.com/people/peyton-l-sloan/87edf6eb-bf9d-4662-ac2b-b3c291f4ea9f)

Company: https://www.keypedia.com/companies/amit-g-shah-md/9bb98f29-0f2c-4ecb-975b-39fb34efbc83

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7