# FDA 483 - Oklahoma Blood Institute Norman Center - March 22, 2019

Source: https://www.globalkeysolutions.net/records/483/oklahoma-blood-institute-norman-center/63c0b9f9-7bca-4fc8-a9e0-e0e28a125cf7

> FDA 483 for Oklahoma Blood Institute Norman Center on March 22, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oklahoma Blood Institute Norman Center
- Inspection Date: 2019-03-22
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: The FDA inspected Oklahoma Blood Institute in Norman, OK, and issued a Form 483 with four observations. The inspection revealed significant issues with adherence to standard operating procedures, inadequate investigation of discrepancies, equipment control failures, and deficiencies in record-keeping practices. These findings indicate a lack of robust quality control and procedural compliance within the donor center.

## Related Officers

- [Regulatory Project Manager](https://www.globalkeysolutions.net/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)

Company: https://www.globalkeysolutions.net/companies/oklahoma-blood-institute-norman-center/03b16c22-d16c-4475-b45f-e33571a7ba6c

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