Allez Spine, LLC – FDA Warning Letter, Apr 1, 2008

This FDA Warning Letter, dated August 8, 2008, addresses Allez Spine, LLC, following an inspection from March 10 to April 1, 2008. The inspection revealed that the firm's Laguna Polyaxial Pedicle Screw System and Del Mar Monoaxial Pedicle Screw System are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). The firm's responses dated April 15, 2008, and July 2, 2008, were deemed inadequate.

Key violations include: 1. **Failure of management with executive responsibility** to establish and maintain a quality policy (21 CFR 820.20(a)), evidenced by non-adherence to their Quality Manual and incomplete design control records. 2. **Failure to establish and maintain design control procedures** (21 CFR 820.30(a)) for both Laguna and Del Mar systems, with no retrospective design plans completed. 3. **Failure to establish and maintain procedures for validating device design** (21 CFR 820.30(g)), specifically regarding sterilization parameters, which were not validated prior to commercial distribution and differed significantly from post-marketing validation reports. 4.