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Prodrome Sciences USA, LLC failed to submit a required Investigational New Drug (IND) application before conducting a clinical investigation of ProdromeNeuro™ Oil (Omega-3 Plasmalogens), an unapproved drug, in violation of 21 CFR 312.20 and 312.40. An FDA inspection conducted between December 17, 2024, and January 10, 2025, as part of the Bioresearch Monitoring Program, identified that the company did not adhere to applicable statutory requirements of the Federal Food, Drug, and Cosmetic Act and regulations governing clinical investigations and human subject protection. The company's conduct of the open-label study (Protocol Pro-040-Plasm-01) without an active IND violated requirements designed to ensure the rights, safety, and welfare of human subjects in clinical research.