FDA WARNING_LETTER - Spine Smith Holdings, LLC - January 31, 2013

On January 17-31, 2013, an FDA inspection of Spine Smith Holdings, LLC, a specification developer of cervical and lumbar interbody fusion systems and surgical instruments, revealed adulterated devices under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The FDA reviewed the firm's February 13, 2013, response to the FDA 483, finding it lacked sufficient corrective actions. Violations included: 1. **Design Validation (21 CFR 820.30(g))**: Failure to validate device design, specifically lacking testing of multiple sterilization cycles' effects on implant devices. The firm's response cited a CAPA but provided no timeframe or study results. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a))**: Failure to establish and maintain adequate CAPA procedures. Risk evaluations were not conducted or documented for product complaints, such as a broken graft delivery funnel and implants missing tantalum markers. The firm's response did not provide requested risk analysis files or a timeframe for reviewing CAPAs. 3. **Complaint Handling (21 CFR 820.19