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Talk to a SpecialistTalk to a SpecialistDr. Julio R. Flamini and his Clinical Integrative Research Center of Atlanta were cited for violations in the conduct of clinical drug investigations during an FDA inspection conducted February 28 through March 11, 2024. The primary violation involved failure to ensure clinical studies were conducted according to the investigational plan, specifically regarding proper weight-based dosing of an investigational drug as required under 21 CFR 312.60. The inspection was part of FDA's Bioresearch Monitoring Program, which evaluates whether the rights, safety, and welfare of human research subjects have been protected during drug trials.