FDA 483 - Nimesh P. Nagarsheth, M.D. - March 31, 2025

Englewood Community Hospital/Englewood Health, a clinical investigator in Englewood, NJ, was cited for failing to promptly report serious adverse events to the sponsor. The inspection revealed instances where serious adverse events were not entered into the electronic data capture system or reported within required timeframes. This indicates a significant lapse in regulatory compliance regarding patient safety and data integrity in clinical trials.