Coenzyme A, Inc.

CLOSEOUT LETTER Coenzyme A, Inc. MARCS-CMS 540210 — November 06, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Overnight Delivery Recipient: Recipient Name Nickolaos D. Skouras Recipient Title President Coenzyme A, Inc. Coenzyme A, Inc. 12512 Beverly Park Road Suite B1 Lynnwood , WA 98087 United States Issuing Office: 22215 25th Avenue SE Suite 210 Bothell , WA 98021 United States Dear Mr. Skouras: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 540210, dated January 5, 2018. 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/ Miriam R. Burbach District Director Program Division Director Content current as of: 11/13/2018