FDA 483 - Andrew Rezvani, M.D. - August 19, 2022

Andrew Rezvani, M.D., a clinical investigator in Palo Alto, CA, was issued a Form 483 following an FDA inspection. The inspection revealed that the firm failed to conduct an investigation in accordance with its investigational plan. Specifically, Serious Adverse Events (SAEs) and their required follow-up information were not reported to the Sponsor in a timely fashion as mandated by the study protocol.