FDA 483 - Ulhas M. Nadgir, M.D. - October 10, 2024

An FDA inspection of Ulhas M. Nadgir, M.D., Clinical Investigator in Sacramento, CA, from October 7-10, 2024, revealed a significant deviation from the investigational plan. The primary concern was the enrollment and treatment of a study subject who met an exclusion criterion, indicating a failure to conduct the investigation in accordance with the signed statement of investigator.