# FDA 483 - SPINE INNOVATION, LLC - July 19, 2023

Source: https://www.keypedia.com/records/483/spine-innovation-llc/1db34130-ec0a-4480-9b91-360b84506e19

> FDA 483 for SPINE INNOVATION, LLC on July 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SPINE INNOVATION, LLC
- Inspection Date: 2023-07-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Spine Innovation, LLC, a medical device manufacturer in Del Mar, CA, was inspected by the FDA. The inspection revealed one observation regarding the firm's design transfer procedures. Specifically, the firm failed to maintain adequate records demonstrating the correct translation of a Class II medical device design to contract manufacturers for production.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/spine-innovation-llc/f396f52f-e3a2-4102-b5b5-a68723e8c9ee

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6