FDA 483 - David F. Jativa, M.D. - April 25, 2022

An FDA inspection of David F. Jativa, M.D. in Doral, FL, revealed that the clinical investigator failed to conduct a clinical study in accordance with the investigational plan. Specifically, the firm did not properly report, repeat, timely assess, or follow up on clinically significant safety laboratory assessments and adverse events for study subjects. These deficiencies indicate a significant lack of adherence to protocol requirements for subject safety and data integrity.