FDA 483 - Maria A. Carballosa MD - August 26, 2021

An FDA inspection of Maria A. Carballosa, Clinical Investigator, in Hialeah, FL, revealed significant deviations from the investigational plan for a clinical study. The firm enrolled subjects who did not meet inclusion criteria and incorrectly dosed multiple subjects with the investigational product. These findings indicate a failure to adhere to study protocol requirements.