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483
•Texoma Regional Blood Center•May 3, 2019

Texoma Regional Blood Center – FDA 483, May 3, 2019

Record Details

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.

Company
Texoma Regional Blood Center
Inspection date
May 3, 2019
Product type
biologics
Office
Dallas District Office
People
  • Kathleen B. Swat (Supervisory)
  • Nimmy Mathews (Regulatory Project Manager)
View Company Profile

ID · 2a470664-cae7-49b5-ae8e-190920e8f91e

Other documents for Texoma Regional Blood Center
  • 483 - 2024-08-23August 23, 2024

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