FDA WARNING_LETTER - Bertrand P. Cole, D.O./Activmed Practices and Research, LLC - May 16, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Bertrand P. Cole, D.O./Activmed Practices and Research, LLC, following an inspection conducted between May 12 and May 16, 2025. The inspection, part of FDA’s Bioresearch Monitoring Program, identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations, Part 312, concerning the conduct of clinical investigations and protection of human subjects. The primary violation cited was Dr. Cole"s failure to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60). Specifically, all four enrolled subjects in a clinical trial involving an investigational drug were administered incorrect, overdosed quantities of the study drug across multiple visits. These subjects subsequently experienced various adverse events, including nausea, vomiting, and dizziness. The site staff responsible for administration were not originally delegated or trained for this task, and they misunderstood dosing instructions. While Activmed Practices and Research, LLC proposed corrective actions, including staff training and a two-person dosing verification process, the FDA deemed the response inadequate due to insufficient detail on training, new procedures, and Dr. Cole"s oversight plan. The FDA requires a detailed written response within 15 business days outlining comprehensive actions to prevent future violations, emphasizing the investigator"s responsibility for subject safety and data integrity.