FDA 483 - Sohan L. Dua, M.D - September 21, 2023

An FDA inspection of Sohan L. Dua, M.D. in Northridge, CA, a clinical investigator for the TRAVERSE study, revealed significant deficiencies in clinical trial conduct. Observations included the failure to promptly report serious adverse events, including a subject's death, to the study sponsor. Additionally, the firm failed to report unanticipated problems involving risk to human subjects to the Institutional Review Board and did not consistently obtain proper informed consent from subjects.