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

The FDA issued a Warning Letter to Dr. Bertrand P. Cole, D.O., following an inspection of his clinical site conducted from May 12 to May 16, 2025. The inspection, part of FDA’s Bioresearch Monitoring Program, revealed significant deviations from regulatory requirements under the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312, which govern clinical investigations and human subject protection. The primary violation was Dr. Cole"s failure to ensure the clinical investigation was conducted according to the investigational plan. Specifically, four out of four enrolled subjects in a drug study were repeatedly administered an incorrect, substantially higher dose (10 mg) of the investigational drug, rather than the protocol-specified doses of 1.5 mg, 4.5 mg, or 9.0 mg. This misadministration occurred over numerous study visits and resulted in all affected subjects experiencing adverse events, including nausea, vomiting, stomach pain, and dizziness. The letter highlighted that site staff involved in drug administration were not properly delegated or trained. While Dr. Cole"s response included corrective actions like staff training and a new two-person dosing verification process, the FDA deemed it inadequate. The agency requires more detailed information on implemented training and procedures to prevent future violations, as well as a clear explanation of how Dr. Cole, as the clinical investigator, will ensure robust oversight of study procedures. Failure to adequately address these concerns within 15 business days may lead to further regulatory action.