Globus Medical, Inc.

Warning LetterOpen

Daniel T. Scavilla President & CEO Globus Medical, Inc. Valley Forge Business Center 2560 General Armistead Avenue Audubon , PA 19403 United StatesFEI 3004142400Issued Jul 15, 2024Office of Medical Device and Radiological Health Division I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004142400.

Violations6

Issue DateJul 15, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Globus Medical, Inc.
Location: Daniel T. Scavilla President & CEO Globus Medical, Inc. Valley Forge Business Center 2560 General Armistead Avenue Audubon , PA 19403 United States
FEI Number: 3004142400
Country: United States
Issue Date: July 15, 2024
Issuing Office: Office of Medical Device and Radiological Health Division I
Product Type: Medical Devices
Status: Open

Summary

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.

Globus Medical, Inc. FDA Warning Letter, July 15, 2024