FDA 483 - Naseem A. Jaffrani, M.D. - March 13, 2025

An FDA inspection of Naseem A. Jaffrani MD, Clinical Investigator, revealed significant non-compliance in clinical research studies. The firm failed to promptly report serious and non-serious adverse events, did not conduct investigations according to the plan, and maintained inadequate and inaccurate case histories. Additional deficiencies included improper informed consent documentation, unapproved changes by the Institutional Review Board, and insufficient investigational drug disposition records.