# FDA 483 - Cutting Edge Spine - February 02, 2023

Source: https://www.globalkeysolutions.net/records/483/cutting-edge-spine/7c0cdda9-de97-4613-b311-e9fea2558fdd

> FDA 483 for Cutting Edge Spine on February 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cutting Edge Spine
- Inspection Date: 2023-02-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Cutting Edge Spine in Mineral Springs, NC, from January 30 to February 2, 2023, revealed a significant issue with the firm's quality system. The company failed to adequately establish and follow procedures for evaluating suppliers, specifically lacking documentation to demonstrate that suppliers were assessed according to their own established SOPs. This indicates a breakdown in ensuring purchased products and services meet specified requirements.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/cutting-edge-spine/5e17f11f-f611-4d66-b492-3625d345e05e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6