# FDA 483 - Children's Healthcare IRB #1 - February 03, 2023

Source: https://www.keypedia.com/records/483/childrens-healthcare-irb-1/599c4639-3cc5-45c1-8893-f54a45c54dce

> FDA 483 for Children's Healthcare IRB #1 on February 03, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Children's Healthcare IRB #1
- Inspection Date: 2023-02-03
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Children's Healthcare IRB #1 in Minneapolis revealed a significant issue regarding the composition of its Institutional Review Board (IRB) meetings. The firm was cited because its IRB did not consistently include a nonscientific member during convened meetings for non-expedited research reviews, which is a critical component for ensuring comprehensive ethical oversight. This observation indicates a potential deficiency in the IRB's review process for protecting human subjects.

## Related Documents

- [483 - 2020-01-31](https://www.keypedia.com/records/483/childrens-healthcare-irb-1/3e9726e7-aa0b-4bcf-b855-c3f029aa0992)

## Related Officers

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

Company: https://www.keypedia.com/companies/childrens-healthcare-irb-1/96db50a9-f32e-4640-a119-94b7a4753175

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