# FDA 483 - HealthPartners Institute IRB - May 28, 2019

Source: https://www.keypedia.com/records/483/healthpartners-institute-irb/e8b18c52-588e-444d-8b60-bd72ae8cb711

> FDA 483 for HealthPartners Institute IRB on May 28, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthPartners Institute IRB
- Inspection Date: 2019-05-28
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Documents

- [483 - 2022-03-14](https://www.keypedia.com/records/483/healthpartners-institute-irb/f21e6669-59db-48e8-858e-b346ad029312)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/healthpartners-institute-irb/62b8d4dd-4b68-4e32-9b08-6fb2845f305f

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d