# FDA WARNING_LETTER - X Spine Systems, Inc. - April 18, 2008

Source: https://www.globalkeysolutions.net/records/warning_letter/x-spine-systems-inc/42704eaf-0d8b-4ee6-ad6d-0f13fd02a9dd

> FDA WARNING_LETTER for X Spine Systems, Inc. on April 18, 2008. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: X Spine Systems, Inc.
- Inspection Date: 2008-04-18
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: On April 7-18, 2008, an FDA inspection of X Spine Systems, Inc. in Miamisburg, Ohio, revealed that their implantable spinal systems were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 C.F.R. Part 820).

Key violations included:
1.  **Failure to identify all corrective and preventive actions for nonconforming products (21 C.F.R. § 820.100(a)(3))**: Specifically, the Spider Cervical Plating System's original package insert listed unvalidated sterilization methods. A revised insert was issued after validation, but customers were not notified about the unvalidated methods used for previously distributed products.
2.  **Inadequate complaint handling procedures (21 C.F.R. § 820.198(a)(3))**: No documented Medical Device Report (MDR) assessments for five complaints since January 2006.
3.  **Failure to record complaint investigation dates and results (21 C.F.R. § 820.198(e)(6))**: Four of six complaints lacked documented failure investigations, including investigator and date.
4.  **Failure to

## Related Officers

- [Senior Director](https://www.globalkeysolutions.net/people/virginia-r-connelly/a699179f-409c-41f6-8555-c6535d6813ea)

Company: https://www.globalkeysolutions.net/companies/x-spine-systems-inc/bef0ddb4-e614-4ec6-af45-b371070a73c7

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22