FDA 483 - Anuj Bhargava MD - September 27, 2019

Anuj Bhargava, a clinical investigator in West Des Moines, IA, was cited for failing to conduct investigations in accordance with the investigational plan. The firm did not report multiple adverse events of special interest (AESI) and a serious adverse event (SAE) to the sponsor and/or IRB as required by the protocol. This indicates a significant lapse in patient safety reporting and adherence to study protocols.