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483
•Jorge Amaya, MD•November 17, 2021

Jorge Amaya, MD – FDA 483, Nov 17, 2021

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)
View Company Profile

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

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