# FDA 483 - Mikell Jaratt, M.D. - February 24, 2022

Source: https://www.keypedia.com/records/483/mikell-jaratt-md/f9ce38f1-d49d-49e7-8a7e-ff295dff6074

> FDA 483 for Mikell Jaratt, M.D. on February 24, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mikell Jaratt, M.D.
- Inspection Date: 2022-02-24
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Mikell Jaratt, M.D. in Gastonia, NC, from February 14-24, 2022, identified a critical failure in reporting unanticipated problems to the Institutional Review Board (IRB). The clinical investigator did not promptly notify the IRB about a study subject's multiple hospitalizations and concurrent medication, despite discovering the issue over a month prior to notification. This lapse indicates a significant deviation from human subject protection protocols.

## Related Officers

- [Brandy D. Brown](https://www.keypedia.com/people/brandy-d-brown/667c6b9a-6ab9-42d4-b364-a96207bca072)

Company: https://www.keypedia.com/companies/mikell-jaratt-md/14704ff5-b83f-4adb-bf11-0f35cf39a378

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