SpineNet LLC. – FDA Warning Letter, Feb 1, 2013

On May 31, 2013, the FDA issued a Warning Letter to SpineNet, LLC, following an inspection from January 29 to February 1, 2013. The inspection revealed that SpineNet's devices, including the SpineNet ACC System, Apollon and Vane Pedicle Screw Systems, and SpineNet Bone Marrow Aspiration Needle Kit, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) and § 352(o).

Key violations included: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate sterilization cycles for the SpineNet ACC device. 2. **Purchasing Controls (21 CFR 820.50):** Failure to complete purchasing control requirements for suppliers and obtain supplier evaluations. 3. **Incoming Product Acceptance (21 CFR 820.80(b)):** Lack of adequate procedures for inspecting and verifying incoming components, finished implants, and returned goods. 4. **Complaint Handling (21 CFR 820.198(a)):** Absence of adequate procedures for receiving