Alphatec Spine, Inc. – FDA Warning Letter, Feb 11, 2010

On June 21, 2010, the FDA issued a Warning Letter to Alphatec Spine, Inc. following an inspection from January 20 to February 11, 2010. The inspection revealed that Alphatec Spine, Inc., a manufacturer of various spinal implants and associated instrumentation, was not in conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated.

Key violations included: 1. **Failure in Design Validation (21 CFR 820.30(g))**: The firm failed to adequately validate sterilization processes for several product families (Solanas, Deltaloc, Illico, Trestle) with longer steam sterilization cycles, as these were not included in the validation challenge (TR-493). The firm's response was deemed inadequate as no documentation was provided. 2. **Inadequate Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a))**: * A CAPA was not initiated for changes to Solanas Set Screw and Instruments. The revised CAPA procedure lacked a valid statistical rationale for trend identification. * The firm failed to extend review to other implant families to ensure no other drawings/design outputs were missing critical dimensions/specifications, specifically regarding the Solanas Posterior Thor