# FDA 483 - Human Subjects Research Committee - August 22, 2025

Source: https://www.keypedia.com/records/483/human-subjects-research-committee/c197ed57-a02e-4844-98c8-be00110a1d51

> FDA 483 for Human Subjects Research Committee on August 22, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Human Subjects Research Committee
- Inspection Date: 2025-08-22
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Hennepin County Med Ctr's Institutional Review Board (IRB) in Minneapolis revealed two significant observations. The IRB improperly used expedited review procedures for research that did not meet eligibility criteria. Additionally, the facility failed to retain copies of all initial research protocols submitted for review and approval.

## Related Documents

- [483 - 2018-08-23](https://www.keypedia.com/records/483/human-subjects-research-committee/075d4be1-caf7-498d-8158-35ee528ce979)

## Related Officers

- [Stephen O. Agyemang](https://www.keypedia.com/people/stephen-o-agyemang/b420a55d-21ea-46c7-8400-a8f22ca9b423)
- [investigator](https://www.keypedia.com/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.keypedia.com/companies/human-subjects-research-committee/65cd3cb7-a4ed-4b7d-8b4d-1e1d6821ad96

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