# FDA 483 - Wenzel Spine, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/wenzel-spine-inc/f842af5c-a859-4117-9c55-63c64b4056b8

> FDA 483 for Wenzel Spine, Inc. on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wenzel Spine, Inc.
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Wenzel Spine, Inc. in Austin, TX, a device manufacturer, revealed a significant lapse in their quality system. The firm failed to perform and document quality audits for 2023 and 2024, contrary to their own internal procedures. This indicates a potential weakness in their overall quality management system.

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/wenzel-spine-inc/b3ebf86e-3ee5-4b5b-83f0-3f0c2c48f8f8

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