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•American Red Cross Blood Svcs•October 16, 2023

FDA 483 - American Red Cross Blood Svcs - October 16, 2023

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Record Details

An FDA inspection of American Red Cross Blood Svcs in Durham, NC, identified a significant issue regarding data integrity. The firm failed to ensure backup data was exact, complete, and secure, specifically noting an unvalidated blood establishment computer system used in their immunology reference laboratory. This raises concerns about the reliability of patient testing data.

Company
American Red Cross Blood Svcs
Inspection Date
October 16, 2023
Product Type
Biologics
Office
Atlanta District Office
People
  • Steven D. Banks
  • Marla A. Cassidy
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ID · 2a8f1d5e-d851-4821-abd1-a1c32a5c7d32

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