FDA 483 - Robert McBane, M.D. - June 23, 2021

An FDA inspection of Robert D. McBane, M.D., Clinical Investigator, revealed significant non-compliance with investigational plans and regulatory requirements. The firm failed to properly report numerous adverse and serious adverse events, ensure subjects received informed consent forms, and provide adequate oversight of study tasks, including eligibility assessments and delegation of authority. These deficiencies indicate a systemic failure to conduct clinical investigations in accordance with established protocols and commitments.