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

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).