FDA 483 - Alok Gambhir, MD, PhD. - October 01, 2025

An FDA inspection of Alok Gambhir, MD, PhD, a clinical investigator in Atlanta, GA, revealed significant deficiencies in the conduct of clinical trials. Observations included failures in obtaining proper informed consent, ensuring sub-investigator agreements were signed before procedures, and timely reporting of adverse device effects to the sponsor. These findings indicate a need for improved adherence to regulatory requirements for human subject protection and investigational plan execution.