FDA 483 - Vemulkonda Koneti Rao, M.D. - October 07, 2022

An FDA inspection of Vemulkonda Koneti Rao, M.D., a clinical investigator in Bethesda, MD, revealed significant deviations from study protocols. The inspection found that required assessments were not performed for a majority of enrolled subjects and a serious adverse event report was submitted to the sponsor more than 24 hours after it occurred. These issues indicate a failure to conduct investigations in accordance with the signed statement of investigator.