Cafe Valley Bakery, LLC

CLOSEOUT LETTER Cafe Valley Bakery, LLC MARCS-CMS 603875 — November 07, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Brian Owens Recipient Title CEO Cafe Valley Bakery, LLC 7000 W. Buckeye Road Phoenix , AZ 85043 United States bowens@cafevalley.com Issuing Office: Office of Human & Animal Food Operations East 6 United States Dear Mr. Owens: The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2020-HAFE6-02, issued on 03/18/2020. Based on our evaluation, it appears you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the continuing 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/ CDR Kelli L. Wilkinson Director of Compliance Office of Human and Food Operations Division East 6 Content current as of: 11/14/2023 Regulated Product(s) Food & Beverages