FDA 483 - Ravi K. Moparty, MD - December 03, 2021

An FDA inspection of Ravi K. Moparty, MD in Houston, TX, revealed that a clinical investigation was not conducted in accordance with the signed statement of investigator. Specifically, multiple subjects did not have screening and/or study-related procedures performed per the protocol, including issues with randomization timing, post-dose sample collection, and required screening tests. Additionally, informed consent documentation was found to be signed by staff eight weeks after the subject.