# FDA 483 - Globus Medical, Inc. - March 28, 2024

Source: https://www.keypedia.com/records/483/globus-medical-inc/879c3eca-3bbe-4ef2-9c0b-efc04ebfb643

> FDA 483 for Globus Medical, Inc. on March 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Globus Medical, Inc.
- Inspection Date: 2024-03-28
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Globus Medical, Inc. in Methuen, MA, a medical device manufacturer, revealed a significant quality system issue. The firm's device history records for its Excelsius 3D and Excelsius GPS products failed to include required x-ray and laser safety labeling, respectively. This indicates a lack of adherence to manufacturing requirements under 21 CFR 820.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/globus-medical-inc/b5cab827-ee03-429b-9b32-0f2a05244281

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144