FDA EIR - SMITH & NEPHEW ORTHOPAEDICS LTD. - May 15, 2014

An FDA postmarket and Quality System Inspectional Technique (QSIT) inspection was conducted at Smith & Nephew Orthopedics Ltd in Warwick, United Kingdom, from May 12-15, 2014. The primary focus of this re-announced inspection was the Birmingham Hip Resurfacing (BHR) System, specifically reviewing a recent packaging change (PMA Supplement #23) and key quality systems. The inspection comprehensively covered Management Control, Design Control, Corrective and Preventive Actions (CAPA), and Production and Process Control. It was performed under the regulatory framework of FDA's Medical Device Premarket Approval and Post Market Inspectional Guide (C.P. 7383.001) and QSIT Level II inspection guidelines (C.P. 7382.845B). Throughout the four-day inspection, no objectionable observations or significant deviations were identified across any of the reviewed quality systems. As a result, no Form FDA-483, which typically details regulatory violations, was issued to the company's management at the conclusion of the inspection. This favorable outcome indicates the facility's compliance with established quality and regulatory standards for the BHR system. While no specific regulatory actions were required due to the absence of deficiencies, management was professionally reminded of their ongoing responsibility to proactively identify and address any potential quality system weaknesses through their internal audit mechanisms. This inspection reaffirms the company's adherence to relevant medical device regulations.