Clinicon Corp

CLOSEOUT LETTER Clinicon Corp MARCS-CMS 582801 — April 30, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Fritz A. Brauer Recipient Title President / CEO Clinicon Corp 3025 Industry St. Ste. A Oceanside , CA 92054 United States ccfab7@clinicon.com Issuing Office: Division of Medical Device and Radiological Health Operations West United States Dear Mr. Brauer: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #582801 dated June 20, 2019]. 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: 05/11/2021 Regulated Product(s) Medical Devices