UMZU, LLC

CLOSEOUT LETTER UMZU, LLC MARCS-CMS 611501 — September 25, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Food & Beverages Recipient: Recipient Name Michael J. Dobson Recipient Title CEO UMZU, LLC 6325 Spine Rd Boulder , CO 80301-3321 United States quality@umzu.com Issuing Office: Division of Human and Animal Food Operations West IV United States Secondary Issuing Offices United States Dear Mr. Dobson: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 611501, dated October 14, 2022. 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/ E. Mark Harris Program Division Director Office of Human and Animal Food Operations – West Division 4 Content current as of: 10/01/2024 Regulated Product(s) Dietary Supplements Food & Beverages