Cenorin, LLC

CLOSEOUT LETTER Cenorin, LLC MARCS-CMS 434408 — May 20, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: WL SEA 15-09 Product: Medical Devices Recipient: Recipient Name Mr. Fredric R. Radford Recipient Title CEO Cenorin, LLC 6324 South 199th Place Suite 107 Kent , WA 98032 United States rradford@cenorin.com Issuing Office: Office of Medical Device and Radiological Health Operations (Division 3W) United States Dear Mr. Radford: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL SEA 15-09 dated February 12, 2015]. 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, /S/ Jessica Mu Director of Compliance Branch Office of Medical Device and Radiological Health Division 3/West Content current as of: 05/26/2020 Regulated Product(s) Medical Devices