# FDA 483 - National Marrow Donor Program IRB - April 04, 2023

Source: https://www.keypedia.com/records/483/national-marrow-donor-program-irb/bf9c3870-7d31-4559-85c4-8c293e741e77

> FDA 483 for National Marrow Donor Program IRB on April 04, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: National Marrow Donor Program IRB
- Inspection Date: 2023-04-04
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of the National Marrow Donor Program IRB in Minneapolis, MN, revealed a significant deficiency in their review procedures. The Institutional Review Board improperly utilized expedited review for changes to previously-approved research protocols that were not minor in nature. This indicates a failure to adhere to appropriate review standards for research modifications.

## Related Officers

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

Company: https://www.keypedia.com/companies/national-marrow-donor-program-irb/22a433e9-79e6-439d-9f45-62edb8ddb5f2

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