FDA 483 - Sagar Sardesai, M.D. - February 12, 2021

The FDA inspected Sagar Sardesai, M.D. at the Ohio State Comprehensive Cancer Center, James Cancer Hospital in Columbus, OH, from February 5-12, 2021. The inspection revealed a significant issue regarding the failure to promptly report serious adverse events to the sponsor, as required by protocol specifications for investigational drugs. This indicates a lapse in critical safety reporting procedures during clinical trials.