FDA WARNING_LETTER - Advanced Surgical Design & Manufacture, Ltd. - July 01, 2010

On December 1, 2010, the FDA issued a Warning Letter to Advanced Surgical Design & Manufacture, Ltd. following an inspection from June 28 to July 1, 2010, in St. Leonards, Australia. The inspection revealed that the firm's cemented Active Total Knee System and associated surgical tools were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Nine violations were identified: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), specifically regarding data analysis from various quality sources. The firm's response was inadequate, lacking implementation evidence and cause discussion. 2. Failure to adequately establish and maintain design change procedures (21 CFR 820.30(i)), with no documented design validation for the (b)(4) Active Knee Femoral Implant. The response was inadequate, contradicting inspection statements and lacking evidence. 3. Failure to validate processes not fully verifiable by inspection (21 CFR 820.75(a)), such as cleaning and packaging for Meniscal Insert Products. The response was inadequate, lacking implementation evidence. 4. Failure to ensure suitability of inspection, measuring, and test equipment (21 CFR 820.