FDA 483 - Lucky Flores, M.D. - March 03, 2022

An FDA inspection of Lucky (NMI) Flores, a Clinical Investigator in Miami Lakes, FL, revealed a significant deficiency in the conduct of a clinical study. The investigator failed to ensure that electronic screening questionnaires were properly completed and verified, leading to the enrollment of subjects with missing eligibility data. This indicates a lack of adequate oversight and adherence to the signed statement of investigator.