Desserts by Helen, Inc.

CLOSEOUT LETTER Desserts by Helen, Inc. MARCS-CMS 659181 — March 15, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Mr. Craig A. Friedman Recipient Title Vice President Desserts by Helen, Inc. 283 Thompson Avenue Louisville , KY 40206-1071 United States craig@dessertsbyhelen.com Issuing Office: Division of Human and Animal Food Operations East V United States Secondary Issuing Offices United States Dear Mr. Friedman: The Food and Drug Administration has completed evaluation of Dessert by Helen Inc. corrective actions in response to our Warning Letter 659181, dated September 11, 2023. Based on our evaluation, it appeared 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/ Allison C. Hunter Compliance Officer Office of Human & Animal Foods Operations East 5 Division Content current as of: 03/18/2024 Regulated Product(s) Food & Beverages