# FDA 483 - Pantheon Spinal LLC - January 25, 2018

Source: https://www.keypedia.com/records/483/pantheon-spinal-llc/b613026d-06f7-4e4e-9523-8af568a1a5c6

> FDA 483 for Pantheon Spinal LLC on January 25, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pantheon Spinal LLC
- Inspection Date: 2018-01-25
- Product Type: device
- Office Name: Dallas District Office
- Summary: Pantheon Spinal LLC, a specification developer in Austin, TX, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design validation for spinal implants, lack of established procedures for design changes, and deficiencies in corrective and preventive action (CAPA) and complaint handling procedures. The firm failed to ensure device conformity through validation and properly document and manage quality issues.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/pantheon-spinal-llc/9d235669-54cc-403d-845f-152f84a8d34a)

## Related Officers

- [Iris C. Macinnes](https://www.keypedia.com/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)

Company: https://www.keypedia.com/companies/pantheon-spinal-llc/4609472f-5160-483e-aa9c-1a126e039179

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