Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC
FDA issued a warning letter to Dr. Maggie Jeffries of Avanti Anesthesiology, LLC in Houston, TX, following a 2021 inspection of two clinical investigations involving investigational drugs including MKO Melt®, diazepam, tramadol, ondansetron, and midazolam/ketamine. The agency found that Dr. Jeffries conducted Protocol ANES001 without a required IND, as the study did not qualify for an exemption under 21 CFR 312.2(b)(1) due to significantly increased patient risks from drug combinations and dosing in a cataract surgery population. Additionally, Dr. Jeffries failed to provide subjects with copies of informed consent forms and failed to identify experimental procedures or foreseeable risks in the consent documents. FDA required a written response within 15 business days detailing corrective actions, warning that failure to respond adequately could lead to further regulatory action.
Flagged claims (3)
There are no additional risks or side effects associated with participation in the study. The risks of anesthesia are in the anesthesia consent and do not differ from what you would experience should you not participate in the study.
the drug doses used are in accordance with what is usual and customary in the administration of anesthesia.
MKO Melt® has been on the market for many years and is commonly used for sedation during cataract surgery, and that the drugs in MKO Melt® (midazolam, ketamine, and ondansetron) are well-known and commonly used in the practice of anesthesia.
Required actions (3)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
You should address these deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
Failure to address this matter adequately may lead to regulatory action.
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