FDA 483 - Dipenkumar Modi, M.D. - April 12, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 67296a32-a479-4e55-92a2-db1da30fefbc