FDA 483 - Diego F. Montes, M.D. - October 06, 2025

An FDA inspection of Medgate Life Sciences Group, Corp. in Pembroke Pines, FL, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans and inclusion criteria, as well as issues with maintaining accurate case histories and informed consent forms. These findings indicate serious concerns regarding data integrity and subject protection in their clinical trials.