# FDA 483 - Bay Regional Medical Center IRB - June 04, 2010

Source: https://www.keypedia.com/records/483/bay-regional-medical-center-irb/f9e907b8-5021-4a8b-a0f5-53656bfa0000

> FDA 483 for Bay Regional Medical Center IRB on June 04, 2010. 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: 2010-06-04
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Bay Regional Medical Center IRB in Bay City, MI, was cited for failing to follow its written procedures for conducting initial and continuing review of research. The inspection revealed that the IRB did not assign studies for in-depth review, lacked a proper tracking system for protocol expiration dates, and failed to conduct continuing review of all studies at appropriate intervals, including annually. These deficiencies indicate a lack of adherence to established policies and federal requirements for human subject protection.

## Related Documents

- [483 - 2011-06-24](https://www.keypedia.com/records/483/bay-regional-medical-center-irb/256f06f0-4d7d-4078-b410-5b45d304abb2)

## 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