# FDA 483 - SpineSmith Holdings, LLC - February 13, 2026

Source: https://www.keypedia.com/records/483/spinesmith-holdings-llc/eaf8fab6-7ff8-4ee1-8360-900bb025c3a5

> FDA 483 for SpineSmith Holdings, LLC on February 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpineSmith Holdings, LLC
- Inspection Date: 2026-02-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of SpineSmith Holdings, LLC in Austin, TX, a manufacturer of Class II medical devices, revealed significant deficiencies in product realization planning and control of purchased products. The firm failed to adequately define quality objectives and acceptance criteria for its medical devices, leading to numerous heating-related complaints. Additionally, the company did not properly establish and implement activities to ensure purchased medical devices met specified requirements, particularly concerning sterility and electrical performance testing.

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)

Company: https://www.keypedia.com/companies/spinesmith-holdings-llc/b6aa6bfc-f1b1-4014-8043-eceb50ccdf03

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