U.S. Dairy Unlimited, LLC

CLOSEOUT LETTER U.S. Dairy Unlimited, LLC MARCS-CMS 590413 — March 09, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Reference #: 20-HAFE4-WL-03 Recipient: Recipient Name Mr. Uri Zyman Recipient Title Owner U.S. Dairy Unlimited, LLC 3301 NW 168th Street Miami , FL 33056 United States Issuing Office: Office of Human and Animal Foods Division 4 East United States (787) 729-8500 Dear Mr. Zyman: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-03 dated November 19, 2019. 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. Kind regards, /S/ Edwin Ramos Director of Compliance Branch OHAFO, Division IV East Content current as of: 03/12/2020