FDA 483 - Sanford Clinic North - May 22, 2025
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An FDA inspection of Sanford Clinic North, a hospital blood bank in Fargo, ND, identified a significant deficiency in their adverse reaction investigation procedures. The firm failed to thoroughly investigate reported adverse reactions, specifically regarding transfusions where recipients experienced a rise in temperature, contrary to their own written procedures requiring contamination suspicion and culture. This indicates a lapse in quality control and patient safety protocols.
ID · afcc402a-7ec4-4ad5-afdf-aa134b27f00f