Arthrex, Inc. – FDA EIR, Aug 25, 2016

An FDA inspection of Arthrex, Inc. was conducted from August 8 to August 25, 2016, to assess compliance with the Quality System Regulation (QSR) for medical devices. The inspection focused on management, design, manufacturing, corrective and preventive actions (CAPA), complaint handling, and medical device reporting (MDR). Key deficiencies identified included the firm's failure to establish adequate CAPA procedures, specifically regarding comprehensive root cause analysis and verification of corrective action effectiveness. Furthermore, Arthrex failed to update its device registration to include devices acquired through 510(k) purchases. Previous inspections had also noted issues with supplier controls, the absence of shelf-life studies to support expiration dating, and an ineffective corrective action process and water system validation. The inspection also followed up on a customer complaint regarding an incompatibility between an Arthrex endoscopic instrument and scope. Arthrex management cooperated fully, confirming their commitment to comply with all FDA regulations and promising a written response detailing corrective actions within fifteen working days.