# FDA 483 - Rush University Medical Center IRB - November 13, 2013

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-irb/78a2de75-cfd2-426f-a255-262c751d7656

> FDA 483 for Rush University Medical Center IRB on November 13, 2013. 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: 2013-11-13
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rush University Medical Center IRB in Chicago identified a significant issue regarding IRB meeting quorum. The IRB failed to consistently ensure that convened meetings for non-expedited research reviews included a non-scientist member, leading to numerous instances where quorum was not met between 2002 and 2013. This indicates a serious lapse in adherence to regulatory requirements for human subjects protection.

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## Related Officers

- [Quality Program Specialist/Program Analyst](https://www.globalkeysolutions.net/people/lequita-mayhew/7c553294-3678-4771-acb4-92c4b8fbc0b1)

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