FDA 483 - Luis Hernandez-Rosado, M.D. - August 12, 2025

An FDA inspection of Innovation Medical Research Center in Palmetto Bay, FL, a clinical investigator site, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, subjects failed to complete study restrictions and required training for the protocols under investigation. This indicates a lack of adherence to study protocols and investigator responsibilities.