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RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. was cited for failing to submit required Investigational New Drug (IND) applications before conducting clinical investigations with investigational drugs, violating 21 CFR 312.20 and 312.40. During a March 2021 FDA Bioresearch Monitoring Program inspection, investigators found that the company, acting as a sponsor of multiple clinical studies, did not adhere to statutory requirements under the Federal Food, Drug, and Cosmetic Act and applicable regulations governing the conduct of clinical investigations and protection of human subjects. The company's April 2021 response to the initial inspectional observations did not adequately address these serious compliance failures related to IND submission requirements.