Terumo Medical Corporation

CLOSEOUT LETTER Terumo Medical Corporation MARCS-CMS 483231 — January 08, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Medical Devices Recipient: Recipient Name James Rushworth Recipient Title President/CEO Terumo Medical Corporation 2101 Cottontail Lane Somerset , NJ 08873 United States Issuing Office: Division of Medical Device and Radiological Health Operations East United States Dear Mr. Rushworth: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 483231, dated March 17, 2016 for your firm’s Elkton, MD location. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means Sincerely, /S/ Gina M. Brackett Director, Compliance Branch Office of Medical Devices & Radiological Health Division One - East Content current as of: 01/15/2020 Regulated Product(s) Medical Devices