# FDA 483 - Children's Healthcare IRB #1 - January 31, 2020

Source: https://www.keypedia.com/records/483/childrens-healthcare-irb-1/3e9726e7-aa0b-4bcf-b855-c3f029aa0992

> FDA 483 for Children's Healthcare IRB #1 on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Children's Healthcare IRB #1
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Children's Healthcare IRB #1 in Minneapolis, MN, revealed multiple significant deficiencies in its operations. The firm failed to ensure proper informed consent processes, inappropriately used expedited review for high-risk studies and adverse events, and did not adhere to its own written procedures for reporting unanticipated problems and conducting continuing reviews. Additionally, the IRB did not maintain adequate records of its members or follow its own membership requirements.

## Related Documents

- [483 - 2023-02-03](https://www.keypedia.com/records/483/childrens-healthcare-irb-1/599c4639-3cc5-45c1-8893-f54a45c54dce)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

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