# FDA 483 - Rush University Medical Center IRB - April 02, 2010

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-irb/7cdbe04b-dfbf-4be9-8020-2720c60695c5

> FDA 483 for Rush University Medical Center IRB on April 02, 2010. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rush University Medical Center IRB
- Inspection Date: 2010-04-02
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rush University Medical Center IRB in Chicago revealed three significant issues. The IRB failed to ensure a study involving children complied with specific regulations for pediatric clinical investigations, which was a repeat observation. Additionally, the IRB lacked written procedures for determining significant versus non-significant risk devices and did not properly advise members of research proposals approved via expedited review.

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## Related Officers

- [Kathleen A Scheible](https://www.globalkeysolutions.net/people/kathleen-a-scheible/f1a1864a-1c90-459d-a8ec-b4f24cc32dbe)

Company: https://www.globalkeysolutions.net/companies/rush-university-medical-center-irb/b9bb7c92-cb60-474d-822d-9eedaef36d40

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669