Jorge Amaya, MDNovember 17, 2021

FDA 483 - Jorge Amaya, MD - November 17, 2021

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Record Details

An FDA inspection of Jorge Amaya, MD, a clinical investigator in Miami, FL, revealed one significant observation. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, specifically regarding a subject who received prohibited treatment without completing required washouts. This indicates a serious deviation from clinical trial protocol.

Company: Jorge Amaya, MD
Inspection Date: November 17, 2021
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Emily A. Green (investigator)

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ID · f1e0cbe8-9ecb-4dc2-b5af-312964d2eb95