# FDA 483 - Rosario Hidalgo, MD - December 04, 2012

Source: https://www.globalkeysolutions.net/records/483/rosario-hidalgo-md/a056c7ff-6aaa-43ae-af48-9ec809b6e655

> FDA 483 for Rosario Hidalgo, MD on December 04, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rosario Hidalgo, MD
- Inspection Date: 2012-12-04
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Rosario Hidalgo, MD in Tampa, FL, a clinical investigator, revealed two observations. The firm failed to obtain informed consent from a human subject prior to conducting study-related tests. Additionally, an investigation was not conducted in accordance with the signed statement of investigator and investigational plan, specifically involving a prohibited medication.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)

Company: https://www.globalkeysolutions.net/companies/rosario-hidalgo-md/ddc421a1-009d-4cb8-81de-f0771f01dada

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