FDA 483 - Carlos M. Martinez, M.D. - November 01, 2022

An FDA inspection of Carlos M. Martinez, M.D. in Cutler Bay, FL, a clinical investigator, revealed a significant deviation from investigational plans. The firm failed to conduct investigations in accordance with the signed statement of investigator and investigational plan. Specifically, study staff instructed subjects to change e-diary PIN codes for daily dosing and symptom data, bypassing the required helpdesk contact.