# FDA 483 - Globus Medical, Inc. - October 16, 2025

Source: https://www.keypedia.com/records/483/globus-medical-inc/6bdac96f-8018-4f7a-9ed8-92f318de9f98

> FDA 483 for Globus Medical, Inc. on October 16, 2025. Product: devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Globus Medical, Inc.
- Inspection Date: 2025-10-16
- Product Type: devices
- Office Name: Philadelphia District Office
- Summary: During an inspection by the U.S. Food and Drug Administration (FDA) from September 24 to October 16, 2025, medical device manufacturer Globus Medical, Inc., located in Audubon, PA, received a Form FDA-483. The primary observation noted was a failure to submit Medical Device Reports (MDRs) within the required 30-day timeframe after becoming aware of device malfunctions. Specifically, the inspection revealed that Globus Medical, Inc. received 44 customer complaints between August 22, 2024, and August 1, 2025, concerning their ExcelsiusGPS (EGPS) Navigation System. These complaints involved reportable events that should have triggered an MDR submission to the FDA but were not reported within the statutory 30-day period. This constitutes a significant compliance issue under the Federal Food, Drug and Cosmetic Act, which mandates timely reporting of adverse events to ensure patient safety and regulatory oversight of marketed devices. As a result of this FDA-483 observation, Globus Medical, Inc. is required to thoroughly investigate the identified issues, address the root causes of the reporting delays, and implement comprehensive corrective and preventive actions. The company must provide a formal response to the FDA outlining how they will ensure future compliance with MDR regulations, thereby upholding their commitment to quality system requirements and patient safety.

## 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)
- [483 - 2024-03-07](https://www.keypedia.com/records/483/globus-medical-inc/4eacc55c-5e73-497e-87a2-9ebe5b3e1a85)
- [WARNING_LETTER - 2024-03-07](https://www.keypedia.com/records/warning_letter/globus-medical-inc/d08f336b-6d1f-4ade-b7b6-208b562e9557)

## 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