FDA 483 - Banji Awosika, M.D. - January 27, 2023

An FDA inspection of Banji Awosika, M.D. in Orlando, FL, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to ensure subjects were dosed only after complete safety lab review and did not properly document adjusted glomerular filtration rate (aGFR) calculations. These failures led to the enrollment of subjects who did not meet study entry criteria.