FDA 483 - Wilfrido A. Benitez, M.D. - July 21, 2022

An FDA inspection of Wilfrido Benitez, M.D. in Hialeah, FL, a clinical investigator, revealed significant deviations from investigational plans and protocols. The observations indicate a failure to ensure subjects completed treatment courses, properly process baseline samples, correctly randomize subjects, and review critical screening laboratory values prior to administering investigational product. These issues raise concerns about the integrity and reliability of the clinical study data.