FDA 483 - Deepak C. D'Souza, M.D. - May 20, 2022

Deepak C. D'Souza, M.D., a Sponsor-Investigator, was cited for failing to conduct a clinical investigation in accordance with the signed statement of investigator and investigational plan. A serious adverse event (SAE) involving hypotension and bradycardia was not identified and reported to the Human Studies Subcommittee and FDA in a timely manner. This constitutes a significant violation of 21 CFR 312.64 regarding investigator responsibilities for reporting adverse events.