483
American Red Cross Blood SvcsFDA 483 - American Red Cross Blood Svcs - October 16, 2023
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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.
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ID · 2a8f1d5e-d851-4821-abd1-a1c32a5c7d32