Randy D. Hicks, M.D. – FDA 483, Sep 12, 2024

Regional Medical Imaging, a clinical investigator in Flint, MI, was cited for significant deficiencies in its conduct of an investigational study. Observations included unauthorized protocol modifications, delayed reporting of severe adverse events including subject deaths, incomplete device accountability records, and deficiencies in informed consent documentation regarding compensation for injury and record retention. These issues indicate a lack of adherence to the investigational plan and regulatory requirements for clinical trials.