FDA 483 - Ehsan Sadri MD - April 16, 2025

Ehsaan NMI Sadri, MD, a clinical investigator in Newport Beach, CA, was cited for significant deficiencies during an FDA inspection of human clinical studies under INDs. The inspection revealed failures to conduct investigations according to the investigational plan, including incomplete subject eligibility assessments, improper investigational product handling, and missed patient reported outcome questionnaires. Additionally, the firm failed to maintain complete case histories, specifically lacking records of investigational product in-transit temperatures.