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Investigation Details
In a filing with the U.S. Securities and Exchange Commission on August 13, 2024, Globus disclosed that “[o]n July 16, 2024, Globus Medical, Inc. received a warning letter from the U.S. Food and Drug Administration (the ‘FDA’) following an inspection of our facilities in Audubon, Pennsylvania. In the warning letter, the FDA cited deficiencies in the response letters sent by the Company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the Company in connection with the inspection that occurred from February 15, 2024 until March 7, 2024. The letter describes observed non-conformities in establishing and maintaining product complaint procedures, including complaint investigations, trending, risk reconciliation, and Medical Device Report (MDR) procedures including timely reporting, pertaining to the ExcelsiusGPS® robotic system.”
Following this news, Globus’s stock price fell over 7% the same day.
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