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Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC conducted clinical investigations of investigational anesthetic drugs (diazepam, tramadol, ondansetron, midazolam/ketamine combinations) but failed to adhere to federal requirements under the Food, Drug, and Cosmetic Act and 21 CFR Part 312 governing clinical investigations and human subject protection. An FDA inspection conducted July-August 2021 identified objectionable conditions related to the conduct of two protocols (ANES001 and ANES002), one as a sponsor-investigator and one conducted for Imprimis Pharmaceuticals. While the letter excerpt does not detail the specific violations, the inspection findings indicated non-compliance with applicable statutory and regulatory requirements for protecting human research subjects' rights, safety, and welfare.