# FDA 483 - Northwest Comm Hospital IRB - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/northwest-comm-hospital-irb/ebf71ac5-6f70-4bef-9f1e-7e88c4c51343

> FDA 483 for Northwest Comm Hospital IRB on December 06, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northwest Comm Hospital IRB
- Inspection Date: 2019-12-06
- Product Type: other
- Office Name: Chicago District Office
- Summary: The FDA inspected Northwest Community Hospital IRB in Arlington Heights, IL, and issued a Form 483 with four observations. The inspection revealed deficiencies primarily related to the IRB's written procedures for continuing review, the detail in meeting minutes, the maintenance of IRB member lists, and the retention of correspondence with investigators. These issues indicate a need for improved documentation and adherence to regulatory requirements for IRB operations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/lisa-hayka/a8ca35f8-88e2-4dfb-9881-82f0ac7db8bf)
- [Shalonda F. Childs](https://www.globalkeysolutions.net/people/shalonda-f-childs/c6430e92-8119-4bd8-b93c-f83888956fd5)
- [Susan D. Yuen](https://www.globalkeysolutions.net/people/susan-d-yuen/ea0e32f2-28c1-4a9e-983a-b83c5702ab5a)

Company: https://www.globalkeysolutions.net/companies/northwest-comm-hospital-irb/d32b56be-1011-4422-99f1-2d9e5dbceb78

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