# FDA 483 - Bay Regional Medical Center IRB - June 24, 2011

Source: https://www.keypedia.com/records/483/bay-regional-medical-center-irb/256f06f0-4d7d-4078-b410-5b45d304abb2

> FDA 483 for Bay Regional Medical Center IRB on June 24, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bay Regional Medical Center IRB
- Inspection Date: 2011-06-24
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Bay Regional Medical Center IRB in Bay City, MI, from June 22-24, 2011, revealed significant issues with the IRB's operations. The facility was cited for improperly using expedited review for ineligible research, failing to adhere to its own written review procedures, and maintaining inadequate meeting minutes regarding voting records. These observations indicate a need for improved compliance with regulatory standards for institutional review boards.

## Related Documents

- [483 - 2010-06-04](https://www.keypedia.com/records/483/bay-regional-medical-center-irb/f9e907b8-5021-4a8b-a0f5-53656bfa0000)

## Related Officers

- [investigator](https://www.keypedia.com/people/nancy-a-bellamy/6763cde9-25d6-41ce-b822-bcf1a222a0fd)

Company: https://www.keypedia.com/companies/bay-regional-medical-center-irb/94de7563-e328-4c3c-b40d-72c58c5f7497

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