FDA EIR - Abbott Medical - February 08, 2021

An FDA preapproval inspection of St. Jude Medical, operating as Abbott Medical, Woodridge, located in Saint Paul, MN, was conducted from February 2 to February 8, 2021. This comprehensive inspection focused on the firm's quality system for the Portico FlexNav Delivery System, a component of the Class III Portico Transcatheter Aortic Valve Implantation (TAVI) system, which was under review for Pre-Market Approval (PMA P190023). The inspection adhered to regulatory guidelines outlined in FDA Compliance Programs for Medical Device PMA Preapproval and Postmarket inspections. The scope of the inspection extensively covered management controls, corrective and preventive actions, design controls, and production and process control subsystems. St. Jude Medical (Woodridge) is responsible for manufacturing the FlexNav Delivery System and Loading System, and also prepares tissue components for the Portico Valve. Significantly, the inspection concluded without identifying any main violations or issues. The FDA did not issue a Form 483, "Inspectional Observations," nor were any concerns verbally communicated to the company's management. Consequently, no specific regulatory deficiencies were found, and no mandatory actions were required from St. Jude Medical following this inspection, indicating that the facility was in full compliance with the evaluated quality system regulations.