FDA 483 - Antonio E. Blanco, M.D. - January 30, 2023

Antonio E. Blanco, M.D. in Miami, FL, was cited with two observations during an FDA inspection as a Clinical Investigator. The firm failed to maintain adequate and accurate case histories, with multiple subjects lacking documentation to meet inclusion criteria. Additionally, the investigation was not conducted according to the signed statement of investigator and investigational plan, as subjects did not complete required study procedures or meet inclusion criteria.