# FDA 483 - Elena Valor, M.D. - October 10, 2023

Source: https://www.keypedia.com/records/483/elena-valor-md/bece4bc1-45db-4428-b888-e0de980e2d30

> FDA 483 for Elena Valor, M.D. on October 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elena Valor, M.D.
- Inspection Date: 2023-10-10
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Elena Valor, M.D., a clinical investigator in Miami, FL, revealed significant deviations from investigational plans across two clinical protocols. The inspection found issues including enrollment of ineligible subjects, the unblinded investigator performing blinded assessments, and incorrect investigational product dispensation. These findings indicate a failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan.

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Company: https://www.keypedia.com/companies/elena-valor-md/d00f548e-47b4-4496-b58f-1994967dfc83

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