SpineFrontier, Inc. – FDA Warning Letter, Jul 11, 2012

On August 8, 2012, the FDA issued a Warning Letter to SpineFrontier, Inc. following an inspection from May 23 to July 11, 2012. The inspection found that SpineFrontier, a specification developer and repackager of bone fusion devices like the S-LIFT Intervertebral Body Fusion Device, had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: CAPAs were not opened as required, e.g., for unmaintained complaints prior to January 2012. 2. **Failure to investigate nonconformities (21 CFR 820.100(a)(2))**: CAPA investigations were not assigned within the required 30 days, often taking 50-130 days. 3. **Failure to verify CAPA effectiveness (21 CFR 820.100(a)(4))**: CAPA 103, addressing a device breakage, lacked verification data and similar complaints occurred post-closure. 4.