X Spine Systems, Inc. – FDA Warning Letter, Apr 18, 2008

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