Cook Inc.

CLOSEOUT LETTER Cook Inc. MARCS-CMS 438190 — September 04, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Product: Medical Devices Recipient: Recipient Name Derek Voskuil Recipient Title Vice President and General Manager Cook Inc. 750 N Daniels Way Bloomington , IN 47404-9120 United States Issuing Office: Center for Devices and Radiological Health One Montvale Avenue Stoneham , ME 04231 United States Dear Mr. Voskuil: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2014-DET-16 (CMS Case 438190), issued on September 16, 2014. Based on our evaluation, it appears that you have addressed the violations 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 yours, /S/ Gina M. Brackett Director, Compliance Branch Office of Medical Device & Radiological Health Division-1 East Office of Regulatory Affairs U.S. Food and Drug Administration Content current as of: 09/13/2018 Regulated Product(s) Medical Devices