FDA 483 - Suresh Anne, M.D. - February 13, 2026

An FDA inspection of Suresh Anne, M.D., a clinical investigator in Flint, MI, revealed significant deviations from investigational plans and protocols. The firm failed to enroll eligible subjects and did not follow required safety monitoring procedures for investigational products. Additionally, the investigator did not promptly report non-serious adverse events to the sponsor as required by the study protocol.