FDA 483 - Spineology, Inc. - April 17, 2025

An FDA inspection of Spineology, Inc. in Saint Paul, MN, from April 15-17, 2025, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately address the repeated use of expired medical devices, resulting in multiple instances of such devices being implanted in patients. This indicates a serious breakdown in quality control regarding product shelf life and CAPA effectiveness.