# FDA 483 - Kwabena (NMI) Ayesu, M.D. - January 27, 2023

Source: https://www.keypedia.com/records/483/kwabena-nmi-ayesu-md/5cdbdc19-b40e-466b-9d16-feb8f6dc5159

> FDA 483 for Kwabena (NMI) Ayesu, M.D. on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kwabena (NMI) Ayesu, M.D.
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Kwabena (NMI) Ayesu, M.D., a clinical investigator in Orlando, FL, was cited for significant deviations from investigational plans and regulatory requirements. The inspection revealed failures in calculating absolute glomerular filtration rates (aGFR) for study subjects, leading to the enrollment of ineligible participants. Additionally, the firm failed to promptly report unanticipated problems involving risk to human subjects to the Institutional Review Board (IRB).

## Related Officers

- [investigator](https://www.keypedia.com/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)

Company: https://www.keypedia.com/companies/kwabena-nmi-ayesu-md/9e5eea3e-0997-4f23-a9f3-935bec5b4c97

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6