FDA 483 - Globus Medical, Inc. - March 07, 2024

An FDA inspection of Globus Medical, Inc. in Audubon, PA, revealed significant deficiencies in their medical device reporting (MDR) and complaint handling processes. The firm failed to submit timely MDRs for serious injuries and malfunctions, and lacked proper documentation for eMDR submissions and complaint investigations. Additionally, procedures for corrective and preventive actions and complaint evaluation were not adequately established.