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

Source: https://www.globalkeysolutions.net/records/483/edwin-nmi-dejesus-md/3115e4c6-39d9-431b-aef9-52dc25fd9d83

> FDA 483 for Edwin (NMI) DeJesus, M.D on September 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edwin (NMI) DeJesus, M.D
- Inspection Date: 2021-09-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/latrice-g-jones/308e84ec-6e35-425d-8b24-e7f6c5391db5)

Company: https://www.globalkeysolutions.net/companies/edwin-nmi-dejesus-md/af2d7c77-421f-40cc-8600-5cca4bc4facf

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