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

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.