# FDA 483 - University Of Michigan - IRBMED - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/university-of-michigan-irbmed/9e6aca07-0823-45ab-9623-be1351ce1812

> FDA 483 for University Of Michigan - IRBMED on September 02, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Of Michigan - IRBMED
- Inspection Date: 2022-09-02
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected the University of Michigan - IRBMED, an Institutional Review Board, from August 29 to September 2, 2022. The inspection revealed two observations related to the IRB's failure to follow its written procedures for continuing review of research and for communicating expedited review approvals to the full board. These findings indicate deficiencies in the IRB's adherence to its own established protocols for oversight of research studies.

## Related Documents

- [483 - 2022-09-02](https://www.globalkeysolutions.net/records/483/university-of-michigan-irbmed/83235466-0f37-4700-b140-adcdde99e043)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-a-kemp/51aa8f2f-ba64-47d3-aa06-b4595b3d15c8)
- [investigator](https://www.globalkeysolutions.net/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)
- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.globalkeysolutions.net/companies/university-of-michigan-irbmed/2de0ec10-b613-4e4d-9f4a-da48d309f8ca

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0