483
Sagar Sardesai, M.D.Sagar Sardesai, M.D. – FDA 483, Feb 12, 2021
Record Details
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.
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ID · f9d36c46-575a-4013-811f-f6de71041a70
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