# FDA 483 - Marta R. Fernandez, M.D. - February 12, 2024

Source: https://www.keypedia.com/records/483/marta-r-fernandez-md/0778490b-39e7-4249-9fa8-cba2a6466244

> FDA 483 for Marta R. Fernandez, M.D. on February 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marta R. Fernandez, M.D.
- Inspection Date: 2024-02-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Marta R. Fernandez, M.D., a clinical investigator in Miami Gardens, FL, was cited for significant deficiencies in clinical investigation practices. Observations included failures in documenting parental consent for minor subjects, maintaining accurate and consistent informed consent forms and case histories, and adhering to the investigational plan by enrolling subjects based on unevaluable data. These issues indicate a lack of control over critical aspects of human subject protection and data integrity in clinical trials.

## Related Officers

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

Company: https://www.keypedia.com/companies/marta-r-fernandez-md/c8e4d98a-637f-4448-88d5-282fac1e7062

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