FDA WARNING_LETTER - Ehsan Sadri MD - April 16, 2025

On March 27, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Ehsan Sadri, M.D., following an inspection of his clinical research site in Newport Beach, California, conducted between March 27 and April 16, 2025. The inspection focused on his role as a clinical investigator for two studies involving investigational ophthalmic drugs. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act and regulations governing clinical investigations.

The primary violation was Dr. Sadri’s failure to adhere to the investigational plan by enrolling participants who did not meet eligibility requirements. Specifically, one subject was enrolled without a required corneal cell density measurement, and another was admitted despite having intraocular pressure readings that fell outside the protocol’s specified range. These failures occurred among a small sample size, raising concerns regarding participant safety and the overall reliability of the study data.

While Dr. Sadri initially responded to these findings by citing shortened enrollment periods and proposing new checklists and staff training, the FDA deemed his response insufficient. The agency noted that his plan lacked detail on how he would provide adequate oversight of study procedures. Dr. Sadri is required to submit a written response within 15 business days detailing the specific corrective actions taken to prevent future violations. Failure to address these concerns adequately may result in further regulatory action.