The Royal Ice Cream Company Inc.

CLOSEOUT LETTER The Royal Ice Cream Company Inc. MARCS-CMS 630433 — April 07, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name James S Orfitelli Recipient Title President The Royal Ice Cream Company Inc. 27 Warren St Manchester , CT 06040-6534 United States Issuing Office: Human Foods Program United States DATE: April 7, 2025 CMS Case: 630433 Dear Mr. Orfitelli: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 630433) on July 28, 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 correction s. 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/ Robyn R. Jones, Branch Chief Conventional Foods Enforcement Branch 2 Office of Compliance and Enforcement Human Foods Program Content current as of: 04/10/2025 Regulated Product(s) Food & Beverages