1ViZN LLC

CLOSEOUT LETTER 1ViZN LLC MARCS-CMS 522724 — February 06, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Recipient: Recipient Name M. Bruce Davis Recipient Title Founder and President 1ViZN LLC 1ViZN LLC 1180 N Mountains Springs Parkway Springville , UT 84663 United States Issuing Office: Center for Food Safety and Applied Nutrition United States The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Amended Warning Letter DEN-17-16-WL, dated August 23, 2017. 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/ LaTonya M. Mitchell Program Division Director Office of Human and Animal Food Operations - Division IV West Content current as of: 03/21/2019