# FDA 483 - Atlas Spine, Inc. - July 19, 2019

Source: https://www.globalkeysolutions.net/records/483/atlas-spine-inc/3371e6a3-2661-4764-8da0-c92dbf0207c0

> FDA 483 for Atlas Spine, Inc. on July 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlas Spine, Inc.
- Inspection Date: 2019-07-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Atlas Spine, Inc., a medical device manufacturer in Jupiter, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, process controls for orthopedic instruments, and employee training. These issues indicate a lack of robust quality management practices.

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## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/atlas-spine-inc/9d5ac551-56ca-410c-9a80-d98ab23d9a65

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6