FDA 483 - Susheel Kodali, M.D. - November 26, 2025

An FDA inspection of Susheel K. Kodali, MD, Clinical Investigator, revealed a significant failure to report unanticipated serious adverse device effects to the sponsor within the required 10 working days. Four serious adverse events involving three subjects were identified as not being reported in a timely fashion, with delays ranging from 55 to 1244 days. This indicates a serious lapse in regulatory compliance for clinical investigations.