FDA 483 - HealthPartners Institute IRB - May 28, 2019

An FDA inspection of HealthPartners Institute IRB in Minneapolis, MN, revealed significant non-compliance with regulations governing clinical investigations. The IRB failed to properly document risk assessments for studies involving children and medical devices, did not follow its own written procedures for review and reporting, and maintained inaccurate records regarding IRB membership and registration details. These deficiencies indicate a systemic breakdown in the IRB's oversight and adherence to regulatory requirements for human subject protection.