# FDA 483 - Seattle Children's Hospital IRB - March 03, 2026

Source: https://www.keypedia.com/records/483/seattle-childrens-hospital-irb/a30224c4-d43f-43bc-a0b1-99542d1d00ca

> FDA 483 for Seattle Children's Hospital IRB on March 03, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seattle Children's Hospital IRB
- Inspection Date: 2026-03-03
- Product Type: other
- Office Name: Seattle District Office
- Summary: An FDA inspection of Seattle Children's Hospital IRB identified two significant issues regarding the composition of its Institutional Review Board. The IRB failed to consistently include members with primary non-scientific concerns and lacked adequately identified unaffiliated members in a substantial percentage of reviewed meetings. These findings indicate deficiencies in ensuring diverse and independent oversight of research protocols.

## Related Officers

- [Gavin W. Pierce](https://www.keypedia.com/people/gavin-w-pierce/dfc6cdb8-2a63-42f4-8a19-6d394d16ee4d)

Company: https://www.keypedia.com/companies/seattle-childrens-hospital-irb/fcdc6d2d-5a71-4325-b2ea-21e83c701c4a

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913