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# Doctor Failed to Follow Investigational Plan: FDA
- URL: https://www.fdaweb.com/doctor-failed-to-follow-investigational-plan-fda/
- Published: 2026-04-07T12:00:00.000Z
- Updated: 2026-09-14T13:36:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160939

An FDA 3/27-4/16/2025 Bioresearch Monitoring Program inspection of two ophthalmological clinical trials conducted by Dr. **Ehsan Sadri** in Newport Beach, CA, found that Sadri failed to ensure that the investigations were conducted according to the investigational plan. A 3/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ehsan-sadri-md-726342-03272026?ref=fdaweb.com) says his written response to the inspection observation was inadequate because it did not contain sufficient details about how he, as the clinical investigator, will ensure adequate oversight of the study procedure. The letter says Sadri’s response also did not contain sufficient details about the proposed changes to policies and procedures being implemented at the site to prevent similar violations in the future.

“Without this information,” FDA says, “we are unable to determine whether your corrective action plan is adequate to prevent similar violations in the future.”