FDA 483 - Omid Tehrani, M.D. - April 14, 2022

Omid Tehrani, M.D., a clinical investigator in San Jose, CA, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This included not administering required eye drops to a subject who subsequently experienced ocular adverse events, and failing to report these and other adverse events to the sponsor. Additionally, the firm failed to prepare and maintain adequate and accurate case histories.