FDA 483 - Globus Medical, Inc. - March 28, 2024

An FDA inspection of Globus Medical, Inc. in Methuen, MA, a medical device manufacturer, revealed a significant quality system issue. The firm's device history records for its Excelsius 3D and Excelsius GPS products failed to include required x-ray and laser safety labeling, respectively. This indicates a lack of adherence to manufacturing requirements under 21 CFR 820.