483
American Red Cross Blood SvcsFDA 483 - American Red Cross Blood Svcs - March 19, 2026
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The FDA inspected American Red Cross Blood Svcs in Durham, NC, and identified a significant deficiency related to computer system validation. The firm failed to maintain written records and appropriate validation data for its blood establishment computer system, which is used for critical immunology reference laboratory functions. This indicates a serious lapse in quality control and data integrity for blood product testing.
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