FDA 483 - Anil C. Odhav, M.D. - June 10, 2019

Anil C. Odhav, M.D., a clinical investigator in Houston, TX, was inspected by the FDA from June 4-10, 2019. The inspection revealed significant deviations from protocol, including the failure to promptly report serious adverse events to the sponsor for multiple subjects. Additionally, the investigation was not conducted in accordance with the signed statement of investigator, as subjects were enrolled despite meeting exclusion criteria and were on prohibited concomitant medications.