Edwin (NMI) DeJesus, M.DSeptember 28, 2021

FDA 483 - Edwin (NMI) DeJesus, M.D - September 28, 2021

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Record Details

An FDA inspection of Edwin (NMI) DeJesus, M.D. in Orlando, FL, identified a significant deviation in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and protocol by enrolling three out of five subjects who did not meet the specified inclusion or exclusion criteria. This indicates a serious breach in clinical trial integrity.

Company: Edwin (NMI) DeJesus, M.D
Inspection Date: September 28, 2021
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Latrice G. Jones (issuing_officer)

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ID · 3115e4c6-39d9-431b-aef9-52dc25fd9d83