FDA EIR - SMITH & NEPHEW (SUZHOU) LIMITED - July 09, 2014

An FDA cGMP inspection of Smith & Nephew Medical (Suzhou) Limited, a Class I sterile medical device manufacturer, was conducted from July 7-9, 2014, in Suzhou, China. This was the first FDA inspection for the facility. The inspection was a comprehensive evaluation of the company's quality systems, including Management Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls, in accordance with the Guide to Inspections of Quality Systems and CPGM 7382.845. Although no formal FDA 483 inspectional observations were issued, the investigator identified several areas for improvement during the close-out meeting. These included strengthening document control practices, particularly ensuring complete data entry on production documents, enhancing the rigor of complaint investigations, and advising against consolidating multiple CAPA issues. The firm was also encouraged to define all acronyms within their Standard Operating Procedures. Management committed to addressing these issues, retraining employees, and continuously improving their processes to ensure full compliance with the FD&C Act.