# FDA 483 - Globus Medical, Inc. - March 07, 2024

Source: https://www.keypedia.com/records/483/globus-medical-inc/4eacc55c-5e73-497e-87a2-9ebe5b3e1a85

> FDA 483 for Globus Medical, Inc. on March 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Globus Medical, Inc.
- Inspection Date: 2024-03-07
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Globus Medical, Inc. in Audubon, PA, revealed significant deficiencies in their medical device reporting (MDR) and complaint handling processes. The firm failed to submit timely MDRs for serious injuries and malfunctions, and lacked proper documentation for eMDR submissions and complaint investigations. Additionally, procedures for corrective and preventive actions and complaint evaluation were not adequately established.

## Related Documents

- [WARNING_LETTER - 2013-06-04](https://www.keypedia.com/records/warning_letter/globus-medical-inc/81aa3d9a-93a9-47fa-825c-fba99c10e2e9)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/globus-medical-inc/032e4f3e-c342-45f8-ac8b-fa15c60feb9b)
- [WARNING_LETTER - 2024-03-07](https://www.keypedia.com/records/warning_letter/globus-medical-inc/d08f336b-6d1f-4ade-b7b6-208b562e9557)
- [483 - 2025-10-16](https://www.keypedia.com/records/483/globus-medical-inc/6bdac96f-8018-4f7a-9ed8-92f318de9f98)

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)
- [Investigations](https://www.keypedia.com/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.keypedia.com/companies/globus-medical-inc/28189b72-9de1-4074-9971-5eeb3e956f43

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8