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

Source: https://www.keypedia.com/records/483/jorge-amaya-md/f1e0cbe8-9ecb-4dc2-b5af-312964d2eb95

> FDA 483 for Jorge Amaya, MD on November 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jorge Amaya, MD
- Inspection Date: 2021-11-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)

Company: https://www.keypedia.com/companies/jorge-amaya-md/cc21f812-6f70-4467-9f5a-b9498cf62a53

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6