FDA 483 - Sanford Clinic North - May 22, 2025

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.