FDA 483 - Humberto Hernandez, M.D. - October 13, 2022

An FDA inspection of Humberto Hernandez, M.D. in Sunrise, FL, a clinical investigator, revealed significant deviations in the conduct of a clinical investigation. Specifically, five out of 23 subjects reviewed were improperly screened, enrolled, randomized, and received investigational product despite not meeting inclusion criteria or meeting exclusion criteria. This indicates a failure to adhere to the signed statement of investigator and investigational plan.