FDA 483 - Dario D. Altamirano, DO - February 09, 2022

An FDA inspection of Dario D. Altamirano, a clinical investigator in Hialeah, FL, revealed significant deviations from the signed statement of investigator. The firm failed to properly report adverse events, repeat safety labs, conduct required physical examinations, ensure proper glucometer use, complete source records, and document concomitant medications for subjects in clinical trials. These findings indicate a lack of adherence to study protocols and proper clinical investigation practices.