FDA 483 - Maria A. Carballosa MD - March 06, 2025

Maria A. Carballosa, Clinical Investigator, in Hialeah, FL, was inspected by the FDA from March 4-6, 2025. The inspection revealed a significant deficiency related to the retention of investigational records, including source documents and informed consent forms, for a clinical trial. This indicates a failure to comply with regulatory requirements for recordkeeping.