FDA 483 - Arthur R. Cabrera, M.D. - May 16, 2023

Arthur R. Cabrera, M.D. in Louisville, CO, a clinical investigator, was cited for significant deficiencies across three observations related to clinical trials involving investigational devices. Violations included failures in obtaining proper informed consent, inadequate disclosure to the IRB, and non-compliance with investigational device exemption requirements. Additionally, the firm failed to adequately monitor subject safety and adverse events, and investigational device labeling lacked required information.