FDA 483 - Abbott Vascular Inc - November 15, 2007

Abbott Vascular-Cardiac Therapies in Temecula, CA, was inspected regarding its medical device manufacturing, specifically the Xience V RX Everolimus Eluting Coronary Stent System. The inspection revealed significant deficiencies across design control, process validation, equipment control, and documentation practices. Issues included inadequate acceptance criteria, incomplete validation studies, lack of contamination prevention, and insufficient calibration and complaint handling procedures.