# FDA 483 - Atlas Spine, Inc. - May 27, 2025

Source: https://www.globalkeysolutions.net/records/483/atlas-spine-inc/61d66e97-3a2d-459e-aaf8-2964692b93e8

> FDA 483 for Atlas Spine, Inc. on May 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlas Spine, Inc.
- Inspection Date: 2025-05-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: During an FDA inspection from May 20-27, 2025, Atlas Spine, Inc. in Jupiter, FL, received a Form FDA-483 with one observation. The firm failed to adequately document the review of an MDR reportable complaint, indicating a deficiency in their complaint investigation record-keeping processes.

## Related Documents

- [483 - 2019-07-19](https://www.globalkeysolutions.net/records/483/atlas-spine-inc/3371e6a3-2661-4764-8da0-c92dbf0207c0)

## Related Officers

- [Alex J. Wild](https://www.globalkeysolutions.net/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

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