# FDA 483 - Legacy Health IRB - December 17, 2021

Source: https://www.keypedia.com/records/483/legacy-health-irb/c890a095-597d-48f5-8aaa-ff997a644117

> FDA 483 for Legacy Health IRB on December 17, 2021. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Legacy Health IRB
- Inspection Date: 2021-12-17
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Legacy Health IRB in Portland, OR, revealed critical deficiencies in its oversight of human subject protection. The firm failed to ensure informed consent documents accurately described risks and withdrawal rights, presenting inconsistent information to subjects. Additionally, the IRB did not maintain updated registration information or adhere to its own written procedures for board composition and review processes.

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)

Company: https://www.keypedia.com/companies/legacy-health-irb/dc89bd88-161a-44af-aa86-f582de4e8041

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822