FDA 483 - Jorge L. Martinez Trabal, MD - February 17, 2023

An FDA inspection of Jorge L. Martinez Trabal, MD in Ponce, PR, from February 14-17, 2023, identified a significant issue regarding the conduct of a clinical investigation. The firm failed to conduct an investigation in accordance with the signed agreement and investigational plan. Specifically, protocol-required assessments were not completed or documented for eight subjects, indicating a lack of adherence to study protocols.