FDA 483 - Vemulkonda Koneti Rao, M.D. - October 29, 2025

Vemulkonda K. Rao, M.D., a clinical investigator in Bethesda, MD, was cited for significant deviations from their investigational plan during an FDA inspection. The inspection revealed failures to report adverse events and conduct proper assessments for all five study subjects, as well as inaccurate reporting of concomitant medications for two subjects. These findings indicate a serious lack of adherence to clinical trial protocols.