Spinal Solutiions, LLC – FDA Warning Letter, Sep 15, 2011

On January 19, 2012, the FDA issued a Warning Letter to Spinal Solutions, LLC, following an inspection from July 11 to September 15, 2011. The inspection found that Spinal Solutions, a repacker/kit assembler of spinal implant systems and own-label distributor of spinal implant instruments, was manufacturing adulterated devices under Section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820).

The letter detailed numerous QS violations, including: - Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)). - Failure to establish and maintain procedures to control nonconforming product (21 CFR 820.90(a)). - Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). - Failure to establish and maintain adequate procedures for purchasing controls, including supplier agreements and an Approved Suppliers List (21 CFR 820.50). - Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)) and incoming product acceptance (21 CFR 820.80(b)). - Failure to establish