Angela D. Ritter, M.D. – FDA Warning Letter, Aug 17, 2023

An FDA inspection conducted between August 14 and August 17, 2023, at Dr. Ritter's clinical site, identified significant objectionable conditions related to the conduct of clinical investigations under the Bioresearch Monitoring Program. The inspection revealed failures to adhere to statutory requirements in the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312, specifically concerning expanded access uses. Key violations include the failure to maintain an effective Investigational New Drug (IND) for expanded access use (21 CFR 312.305(c)(5)), leading to unauthorized drug administration beyond the approved two-week period for a subject. The firm also failed to conduct the investigation according to the general investigational plan and protocol (21 CFR 312.50 and 312.60) by continuing to administer unauthorized doses. Furthermore, there was a failure to ensure prospective and continuing Institutional Review Board (IRB) review and approval for subsequent and continued drug use (21 CFR 312.305(c)(4), 312.66, 56.104(c)), and a failure to submit required annual reports to the FDA (21 CFR 312.305(c)(5), 312.33). These deficiencies, attributed partly to reliance on a Contract Research Organization, jeopardized the rights, safety, and welfare of the study subject. The FDA deemed the firm's responses inadequate due to a lack of detailed corrective actions, policies, procedures, and training plans. The firm is required to respond within 15 business days with a comprehensive plan to prevent similar violations, or face potential regulatory action.