# FDA 483 - Oklahoma Blood Institute - IRB - February 27, 2006

Source: https://www.keypedia.com/records/483/oklahoma-blood-institute-irb/f9b97e87-a4ba-4409-bd99-688a79fc0bf9

> FDA 483 for Oklahoma Blood Institute - IRB on February 27, 2006. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oklahoma Blood Institute - IRB
- Inspection Date: 2006-02-27
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Oklahoma Blood Institute - IRB in Oklahoma City revealed significant deficiencies in its Institutional Review Board operations. The firm failed to conduct research reviews at convened meetings, did not promptly notify investigators of approvals, and lacked proper record-keeping for consent documents and adverse event reports. These issues indicate a lack of adherence to established procedures for human subject protection.

## Related Documents

- [EIR - 2006-02-27](https://www.keypedia.com/records/eir/oklahoma-blood-institute-irb/f8cb229d-2b6d-49c8-9e1a-9a24691c2a5b)

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/oklahoma-blood-institute-irb/1d0c993d-ff09-4201-9c55-837129478acf

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9