Globus Medical, Inc.March 7, 2024

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

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Record Details

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.

Company: Globus Medical, Inc.
Inspection Date: March 7, 2024
Product Type: Device
Office: Philadelphia District Office
People: Brian S. Keefer (Investigator at US Food and Drug Administration)
Edward D. McDonald (Investigations)

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ID · 4eacc55c-5e73-497e-87a2-9ebe5b3e1a85