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Globus Medical, Inc. was found to be manufacturing the Excelsius GPS surgical robot and associated spine and cranial modules in violation of FDA's Quality System Regulation (21 CFR Part 820), rendering these Class II medical devices adulterated. During an FDA inspection conducted from February 15 through March 7, 2024, at the company's Audubon, Pennsylvania facility, investigators identified deficiencies in the methods, facilities, and controls used in the manufacture, packing, storage, or installation of these devices. The company submitted responses to the inspection observations on March 28, 2024, and May 31, 2024, but failed to achieve full compliance with current good manufacturing practice requirements.