# FDA 483 - Humberto Hernandez, M.D. - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/humberto-hernandez-md/84c53609-b533-4700-a966-7dd742552fd0

> FDA 483 for Humberto Hernandez, M.D. on October 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Humberto Hernandez, M.D.
- Inspection Date: 2022-10-13
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Humberto Hernandez, M.D. in Sunrise, FL, a clinical investigator, revealed significant deviations in the conduct of a clinical investigation. Specifically, five out of 23 subjects reviewed were improperly screened, enrolled, randomized, and received investigational product despite not meeting inclusion criteria or meeting exclusion criteria. This indicates a failure to adhere to the signed statement of investigator and investigational plan.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/humberto-hernandez-md/8f2b20b2-b61a-49c7-a7d3-cef4a6a2bb65

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