FDA 483 - Dipenkumar Modi, M.D. - April 12, 2023

An FDA inspection of Dipenkumar Modi, M.D., a clinical investigator in Detroit, MI, revealed significant issues with the conduct of clinical investigations and reporting to the Institutional Review Board (IRB). Specifically, the firm failed to follow the investigational plan for a study, resulting in subjects receiving investigational product contrary to the protocol. Additionally, the firm did not promptly report unanticipated problems involving risk to human subjects to the IRB as required.