483
Humberto Hernandez, M.D.FDA 483 - Humberto Hernandez, M.D. - October 13, 2022
Record Details
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.
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ID · 84c53609-b533-4700-a966-7dd742552fd0