# FDA 483 - Eminent Spine, LLC - October 13, 2023

Source: https://www.globalkeysolutions.net/records/483/eminent-spine-llc/da27b17e-a9d7-48cd-9236-c8cf216d7c4f

> FDA 483 for Eminent Spine, LLC on October 13, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Eminent Spine, LLC
- Inspection Date: 2023-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Eminent Spine, LLC, a manufacturer/specification developer in Plano, TX, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in purchasing controls and quality agreements with contract manufacturers, inadequate risk analysis for its 3D Lumbar IBFD - PLIF product, and a deficient Medical Device Reporting procedure that led to unreported serious injuries. These issues indicate a lack of robust quality system controls.

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/eminent-spine-llc/774bd7b0-078b-4c5a-a1cb-127dd00bee23

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab