# FDA 483 - Manuel F. Fernandez, M.D. - February 17, 2023

Source: https://www.keypedia.com/records/483/manuel-f-fernandez-md/5b863606-8f64-4260-b980-5a981b15dfbe

> FDA 483 for Manuel F. Fernandez, M.D. on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manuel F. Fernandez, M.D.
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Manuel F. Fernandez, M.D. in Miami, FL, received an FDA Form 483 for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed that four subjects were randomized and received investigational product despite not meeting the protocol's inclusion criteria. Additionally, one subject's pre-visit diaries did not meet the specified inclusion criteria.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/manuel-f-fernandez-md/8e6dd9bb-e6da-4c35-bdf8-7601293188e8

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