FDA WARNING_LETTER - Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC - August 05, 2021

This FDA Warning Letter (Ref. No.: 23-HFD-45-03-01) was issued to Dr. Jeffries following an inspection from July 19 to August 5, 2021, under the Bioresearch Monitoring Program. The inspection revealed objectionable conditions in the conduct of clinical investigations, specifically Protocol ANES001, involving diazepam, tramadol, ondansetron, and MKO Melt®.

The primary violation was the failure to submit an Investigational New Drug (IND) application for a clinical investigation subject to 21 CFR 312.2(a), as required by 21 CFR 312.20(a), 312.20(b), and 312.40(a). The FDA determined Protocol ANES001 was a clinical investigation, not medical practice, because it involved administering drugs according to a randomization schedule to study efficacy, limiting clinical judgment.

The investigation did not qualify for IND exemption under 21 CFR 312.2(b)(1) because it significantly increased risks and failed to comply with informed consent requirements. Risks were increased by administering drugs to cataract surgery patients, using a 100mg tramadol dose regardless of hepatic function, and concurrent administration of tramadol and diazepam, which can cause profound sedation and respiratory depression. The study lacked adequate safety monitoring, AE monitoring