FDA 483 - Khanjan H. Nagarsheth, MD - August 15, 2025

An FDA inspection of Khanjan H. Nagarsheth, MD in Baltimore, MD, a clinical investigator, revealed significant issues with the conduct of a clinical study. The firm failed to follow its investigational plan, specifically by not timely reporting serious adverse events (SAEs) and unexpected adverse device events (UADEs) to the sponsor as required by the study protocol. This indicates a serious lapse in clinical trial oversight and patient safety reporting.