FDA 483 - Kalyan R. Bhamidimarri MD - January 16, 2020

An FDA inspection of Kalyan R. Bhamidimarri MD, a clinical investigator in Miami, revealed significant deficiencies in the conduct of investigational drug studies. The principal investigator failed to provide adequate oversight, leading to a subject receiving additional study drug and a prohibited medication, which contributed to pulmonary edema and death. Additionally, there were failures to promptly and accurately report serious adverse events and protocol deviations to both the sponsor and the Institutional Review Board (IRB).