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

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.