Universal Pure, LLC

CLOSEOUT LETTER Universal Pure, LLC MARCS-CMS 455150 — May 16, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Reference #: 2015-DAL-WL-28 Product: Food & Beverages Recipient: Recipient Name Jeffrey L. Barnard Recipient Title President Universal Pure, LLC Universal Pasteurization, LLC 1601 Pioneers Blvd. Lincoln , NE 68502 United States Issuing Office: Center for Food Safety and Applied Nutrition United States Dear Mr. Barnard, The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: 2015-DAL-WL-28) dated August 24, 2015, issued following inspection of your facility located at 777 Freeport Pkwy, Ste. 130, Coppell, TX 75019. 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. If you choose to reestablish or sell your operations, 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 Hensley Director of Compliance Office of Human and Animal Food, WD3 Content current as of: 05/28/2019 Regulated Product(s) Food & Beverages