# FDA 483 - Children's Hosp Of WI Institutional Review Board - May 23, 2022

Source: https://www.keypedia.com/records/483/childrens-hosp-of-wi-institutional-review-board/e0e5ad15-056b-494f-97a3-347e4fef2af1

> FDA 483 for Children's Hosp Of WI Institutional Review Board on May 23, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Children's Hosp Of WI Institutional Review Board
- Inspection Date: 2022-05-23
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of the Children's Hospital of Wisconsin Institutional Review Board in Milwaukee identified deficiencies in the preparation of IRB meeting minutes. The inspection revealed that minutes were not detailed enough to accurately reflect attendance and voting actions. Multiple discrepancies were found between member rosters and meeting records, indicating issues with documentation practices.

## Related Documents

- [483 - 2022-05-23](https://www.keypedia.com/records/483/childrens-hosp-of-wi-institutional-review-board/ab373b30-1c90-41d9-9630-666ea240a25d)

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Company: https://www.keypedia.com/companies/childrens-hosp-of-wi-institutional-review-board/dd1daa7b-0b31-4411-96a7-25c914c98011

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