FDA 483 - Rishi Kakar, M.D. - August 09, 2021

An FDA inspection of Rishi Kakar, M.D., a clinical investigator in Miami Lakes, FL, revealed significant protocol deviations. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, multiple subjects enrolled in a double-blind study did not have all required baseline evaluations completed as mandated by the study protocol.