Advanced Surgical Design & Manufacture, Ltd. – FDA Warning Letter, Sep 22, 2011

The FDA issued a Warning Letter to Advanced Surgical Design & Manufacture, Ltd. in St. Leonards, Australia, following an inspection from September 19-22, 2011. The inspection revealed that the firm's Active Total Knee Replacement System devices were adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820). Key violations included failures in process validation for CMM, cleaning, and packaging (21 CFR 820.75(a)); inadequate procedures for design change control (21 CFR 820.30(i)); insufficient supplier management procedures (21 CFR 820.50(a)); lack of adequate environmental control procedures for the facility (21 CFR 820.70(c)); deficiencies in identifying training needs and ensuring personnel competency (21 CFR 820.25(b)); and failure to maintain complete device history records (21 CFR 820.184). While the firm provided responses to most observations, the adequacy of cleaning and packaging process validations could not be determined as they were still in progress. Due to the serious nature of these violations, the firm's Active Total Knee Replacement Systems are subject to refusal of admission into the U.S. under Section 801(a). The FDA requires a written response within fifteen business days detailing specific corrective actions, prevention plans, and a timetable. Furthermore, the firm must submit certification from an outside expert consultant confirming an audit of their manufacturing and quality assurance systems, along with the consultant's report and CEO certification of implemented corrections, before a follow-up inspection will be scheduled. This is particularly critical given the firm's continued non-compliance since a 2010 inspection.