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Dr. Mehran Michael Bahrami was cited for violations of federal regulations governing the conduct of clinical drug investigations at his clinical site in Florida. During an FDA inspection conducted in April 2024, investigators identified that Dr. Bahrami failed to ensure clinical investigations were conducted according to their investigational plans, specifically failing to verify that subjects met all eligibility criteria before enrollment in at least two protocols. The violations pertained to the conduct of human subject research and protection requirements under 21 CFR Part 312.