FDA EIR - SMITH & NEPHEW ORTHOPAEDICS LTD. - January 21, 2010

An FDA inspection of Smith & Nephew Orthopaedics Ltd., located in Warwick, United Kingdom, occurred from January 18-21, 2010. This post-market approval inspection, conducted under medical device quality system regulations (specifically 21 CFR 820), identified four key areas requiring corrective action. The inspection revealed issues including an absence of comprehensive validation for supplier processes, specifically concerning the stability of BHR cup coatings post-cleaning and ensuring the consistency of casting beads to meet specified requirements. Additionally, the company's procedures for accepting or rejecting incoming products were found to be inadequately defined. This involved unclear visual inspection criteria for bead attributes on BHR cups and a lack of documentation verifying bead density compliance. Furthermore, the firm's internal audit procedures were incomplete, as a risk-based approach to scheduling audits was not formally documented, and not all areas of the quality system were consistently audited annually. Lastly, there was a noted lack of documented rationale supporting the adequacy of sampling methods used for incoming BHR instrumentation. Smith & Nephew management expressed cooperation and committed to addressing all observations and implementing necessary corrections to ensure full compliance with regulatory standards.