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Talk to a SpecialistTalk to a SpecialistDr. Americo F. Padilla was cited for violations in the conduct of clinical drug investigations at his Miami Gardens, Florida site during an FDA inspection in February 2024. The primary violation involved failure to obtain informed consent from human subjects in accordance with 21 CFR part 50 requirements, specifically breaching provisions at 21 CFR 50.20, 50.27, and 50.52 that govern the protection of human subjects' rights, safety, and welfare. This inspection was conducted under FDA's Bioresearch Monitoring Program to evaluate compliance with the Federal Food, Drug, and Cosmetic Act and Title 21 Code of Federal Regulations Part 312 governing clinical investigations.