# FDA 483 - Texoma Regional Blood Center - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/texoma-regional-blood-center/2a470664-cae7-49b5-ae8e-190920e8f91e

> FDA 483 for Texoma Regional Blood Center on May 03, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texoma Regional Blood Center
- Inspection Date: 2019-05-03
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Texoma Regional Blood Center in Sherman, TX, revealed significant deficiencies in donor eligibility and record-keeping practices. The firm failed to properly defer unsuitable donors, resulting in the distribution and transfusion of potentially unsafe blood components. Additionally, processing steps for blood units were not concurrently documented, hindering traceability.

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- [483 - 2024-08-23](https://www.globalkeysolutions.net/records/483/texoma-regional-blood-center/ec02d137-692f-47c3-a719-5dff6d05f315)

## Related Officers

- [Supervisory](https://www.globalkeysolutions.net/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)
- [Regulatory Project Manager](https://www.globalkeysolutions.net/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)

Company: https://www.globalkeysolutions.net/companies/texoma-regional-blood-center/cc65fa03-5945-4ee8-b9fb-5fb690840c98

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