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

On July 15, 2024, the FDA issued a Warning Letter to the manufacturer of the Class II Excelsius GPS (EGPS) surgical robot, following an inspection from February 15 to March 7, 2024. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System Regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(1))**: The firm did not initiate CAPAs for recurring issues like misplaced screws despite numerous complaints (e.g., 55 and 76 previous complaints in COM-20-2011 and COM-22-0414, respectively). The FDA found the firm's statistical methodology for trend analysis inadequate, lacking detailed analysis by part numbers, lot numbers, or causes. 2. **Failure to investigate complaints comprehensively (21 CFR 820.198(c))**: Complaint investigations lacked sufficient detail, such as for a patient death (COM-21-3115) where the conclusion of no device malfunction was unsubstantiated, and for a "screw missed pedicle" event (COM-22-0414) without evidence