# FDA 483 - HealthPartners Institute IRB - March 14, 2022

Source: https://www.keypedia.com/records/483/healthpartners-institute-irb/f21e6669-59db-48e8-858e-b346ad029312

> FDA 483 for HealthPartners Institute IRB on March 14, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthPartners Institute IRB
- Inspection Date: 2022-03-14
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of HealthPartners Institute IRB in Bloomington, MN, revealed that the Institutional Review Board failed to follow its own written procedures for the initial and continuing review of research. The deficiencies included inadequate documentation for studies involving vulnerable populations, failure to properly assess investigational device use with MRI, and not completing required reviewer forms or providing written non-significant risk determinations to investigators. These issues indicate a lack of adherence to established internal protocols for IRB oversight.

## Related Documents

- [483 - 2019-05-28](https://www.keypedia.com/records/483/healthpartners-institute-irb/e8b18c52-588e-444d-8b60-bd72ae8cb711)

## Related Officers

- [Investigator](https://www.keypedia.com/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

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