# FDA 483 - Evolution Spine LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/evolution-spine-llc/b6917760-c713-44e3-a472-7796450c8c6e

> FDA 483 for Evolution Spine LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evolution Spine LLC
- Product Type: device
- Office Name: Dallas District Office
- Summary: Evolution Spine, LLC, a medical device manufacturer in Dallas, TX, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in translating device design into production specifications and in adequately controlling non-conforming products. These issues highlight concerns regarding the firm's quality system and adherence to regulatory requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.globalkeysolutions.net/companies/evolution-spine-llc/85cf390b-b7de-4e44-9a7a-530afe6529ad

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9