# FDA 483 - Maria I. Bermudez, M.D. - June 28, 2023

Source: https://www.keypedia.com/records/483/maria-i-bermudez-md/c2e1c0a7-7619-4926-80ef-590ee13ae77c

> FDA 483 for Maria I. Bermudez, M.D. on June 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maria I. Bermudez, M.D.
- Inspection Date: 2023-06-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Maria I. Bermudez, M.D., a clinical investigator in Miami, FL, revealed a significant deviation from the investigational plan. The firm failed to properly store serum samples, which experienced multiple temperature excursions, and incorrectly administered investigational product to a subject. These findings indicate a lack of adherence to study protocols and signed investigator statements.

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Company: https://www.keypedia.com/companies/maria-i-bermudez-md/bb8491b4-5de3-4e69-a999-090c6430cb74

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