# FDA 483 - GSource, LLC - July 30, 2024

Source: https://www.keypedia.com/records/483/gsource-llc/49a8ece8-2c6a-4957-8497-8315ddbb2499

> FDA 483 for GSource, LLC on July 30, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GSource, LLC
- Inspection Date: 2024-07-30
- Product Type: device
- Office Name: New Jersey District Office
- Summary: GSource, LLC in Emerson, NJ, a medical device repacker/relabeler/manufacturer, was cited for two significant issues during an FDA inspection. The firm's Medical Device Reporting (MDR) procedure lacked a standardized review process for determining reportable events. Additionally, procedures for receiving and investigating customer complaints were inadequate, failing to properly trend device malfunctions like recurring drill bit breakages across product families.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)

Company: https://www.keypedia.com/companies/gsource-llc/cf9923f9-1e99-49dc-846b-5990f2f335f8

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248