Smith & Nephew, Inc. – FDA EIR, Aug 17, 2016

An FDA Premarket Approval (PMA P150030) inspection was conducted at Smith & Nephew, Inc. located in Memphis, TN, from August 15-17, 2016. This inspection focused on the company's Quality System responsibilities for the R3 Delta Ceramic Acetabular System, a medical device. A related inspection covering design control requirements for the same device took place on August 18, 2016, at their Cordova, TN facility. The inspection was performed under established FDA Compliance Programs for medical device pre-market approval and post-market inspections. Throughout the comprehensive review of management controls, manufacturing and design operations, purchasing controls, complaint handling, corrective and preventive actions, and recall procedures, FDA investigators identified no objectionable conditions. Consequently, an FDA-483, Inspectional Observations, was not issued to Smith & Nephew management at either facility, indicating full compliance with regulatory requirements during this assessment. No samples were collected, and no refusals were encountered. The Establishment Inspection Reports will be submitted to the Center for Devices and Radiological Health (CDRH) for review regarding the PMA application.