Old Europe Cheese, Inc.

CLOSEOUT LETTER Old Europe Cheese, Inc. MARCS-CMS 644539 — April 05, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Gilbert Bourgouin Recipient Title General Manager Old Europe Cheese, Inc. 1330 E. Empire Avenue Benton Harbor , MI 49022-2018 United States gilbert@oldeuropecheese.com Issuing Office: Division of Human and Animal Food Operations East VI United States Secondary Issuing Offices United States Dear Mr. Bourgouin: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on March 17, 2023. Based on our evaluation, it appears that you have addressed the violations contained in the 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. If you have questions concerning this letter, please contact me at Lauren.Sexton@fda.hhs.gov. Sincerely, /S/ Lauren E. Sexton Compliance Officer Office of Human and Animal Food Operations Division East 6 Detroit District Office Content current as of: 04/08/2024 Regulated Product(s) Food & Beverages