# FDA 483 - Legend Spine, LLC - August 08, 2019

Source: https://www.keypedia.com/records/483/legend-spine-llc/7a4f7c13-3a2d-4928-be11-f816b0fda617

> FDA 483 for Legend Spine, LLC on August 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legend Spine, LLC
- Inspection Date: 2019-08-08
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Legend Spine, LLC in Bethlehem, PA, revealed two significant quality system deficiencies. The firm failed to conduct required quality audits and did not perform management reviews of the quality system at defined intervals, both as stipulated in their own Quality System Manual. These observations indicate a lack of adherence to established internal quality procedures.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/legend-spine-llc/55d36c55-a2b9-408d-9d57-b88f93ec3fa3

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8