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American Behavioral Research Institute, LLC was cited for failing to submit a required Investigational New Drug (IND) application before conducting a clinical investigation of Relaxium® Sleep, a violation of 21 CFR 312.20(a), 312.20(b), and 312.40(a). The company, acting as both sponsor and clinical investigator, did not adhere to Federal Food, Drug, and Cosmetic Act requirements and applicable regulations governing the conduct of clinical investigations and protection of human subjects under Protocol ABRI-002. The FDA inspection was conducted between April 17 and May 3, 2024, as part of the agency's Bioresearch Monitoring Program to evaluate research conduct and ensure human subject protections.