Euro USA, Inc.

CLOSEOUT LETTER Euro USA, Inc. MARCS-CMS 666173 — September 17, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Mr. Joseph O’Donnell Recipient Title Chief Executive Officer Euro USA, Inc. 4481 Johnston Parkway Cleveland , OH 44128 United States duff@eurousa.com Issuing Office: Division of Human and Animal Food Operations East V United States Secondary Issuing Offices United States Dear Mr. O’Donnell: The Food and Drug Administration has completed an evaluation of Euro USA, Inc. corrective actions in response to our Warning Letter 666173, dated November 22, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Further 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/ Allison C. Hunter Compliance Officer Office of Human and Animal Food Operations East 5 Division Content current as of: 09/23/2024 Regulated Product(s) Food & Beverages