FDA WARNING_LETTER - Maria A. Carballosa, M.D. - March 06, 2025

The FDA issued a Warning Letter to Dr. Maria A. Carballosa of Power MD Clinical Research Institute, following an inspection conducted from March 4 to March 6, 2025. The inspection, part of FDA’s Bioresearch Monitoring Program, reviewed her conduct of a clinical investigation for an investigational drug. The primary violation identified was a failure to retain required records under the Federal Food, Drug, and Cosmetic Act and 21 CFR 312.62(c). Specifically, Dr. Carballosa failed to retain records of the study drug"s disposition, including dates, quantity, and use by subjects, as well as adequate and accurate case histories, such as signed consent forms, case report forms, and supporting data for Protocol (b)(4). These records were required because a supplement to a New Drug Application was filed for the drug"s indication, and its approval status is pending. Dr. Carballosa"s response to the FDA 483 acknowledged the requirement but stated that due to a reorganization of Power MD and the relocation of its owner, she could not keep the records. She claimed FDA permission for the record transfer, but provided no evidence. The FDA found her response inadequate, as it lacked details on how she plans to prevent similar future violations or ensure record retention as required. Dr. Carballosa is required to notify the FDA in writing within 15 business days of receipt of the letter, detailing actions taken to prevent similar violations in the future.