FDA WARNING_LETTER - Jose M. Carpio, M.D. - May 13, 2025

This Warning Letter, issued to Jose M. Carpio, M.D. on May 28, 2026, outlines findings from an FDA inspection of his clinical site in Miami Lakes, Florida, conducted between May 1 and May 13, 2025. The inspection revealed that Dr. Carpio failed to adhere to the investigational plan and clinical research requirements established under the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations. The primary violation involved the failure to dispense required doses of an investigational drug to study subjects. Specifically, three participants were only given medication on the first day of a five-day treatment period, missing mandatory doses on the second and fourth days. This non-compliance compromised the study’s primary objective—assessing the drug"s efficacy—and potentially placed subjects at risk by providing inadequate treatment. While Dr. Carpio previously submitted a response detailing plans for staff training and new verification procedures, the FDA found his response insufficient due to a lack of detail regarding his personal oversight and the specific implementation of these new protocols. Dr. Carpio is required to provide a written update within 15 business days describing the actions taken to prevent future violations and ensure the safety of human subjects. Failure to adequately address these concerns may result in further regulatory action.