# 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/ab373b30-1c90-41d9-9630-666ea240a25d

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

---

## Details

- Record Type: 483
- Company Name: Children's Hosp Of WI Institutional Review Board
- Inspection Date: 2022-05-23
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection conducted at Children's Hosp Of WI Institutional Review Board from May 17 to May 23, 2022, identified an observation regarding the insufficient detail in their Institutional Review Board (IRB) meeting minutes. The primary issue was the failure to accurately document attendance and voting actions, including the number of members voting for, against, and abstaining, as required for proper regulatory oversight. Specifically, a review of meeting minutes over six months revealed multiple discrepancies. These included inconsistencies between member rosters and actual attendance records, such as listed members not being accounted for at specific meetings. Furthermore, voting records showed inaccuracies, with members present but not counted in votes, or the total number of votes not matching the recorded attendance without explanation. In some instances, the total votes exceeded the number of members listed as present, indicating significant record-keeping deficiencies. These observations highlight concerns with the accuracy and completeness of the IRB's operational records, which are crucial for demonstrating compliance with regulatory standards governing human subject research protection. The Children's Hosp Of WI Institutional Review Board is expected to address these identified record-keeping shortcomings to ensure full adherence to established regulatory frameworks.

## Related Documents

- [483 - 2022-05-23](https://www.keypedia.com/records/483/childrens-hosp-of-wi-institutional-review-board/e0e5ad15-056b-494f-97a3-347e4fef2af1)

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.keypedia.com/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

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