Onofrio's Fresh Cut, Inc.

CLOSEOUT LETTER Onofrio's Fresh Cut, Inc. MARCS-CMS 618502 — June 28, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED Product: Food & Beverages Recipient: Recipient Name Mr. Richard A. Onofrio Recipient Title Owner/President Onofrio's Fresh Cut, Inc. 222 Forbes Ave New Haven , CT 06512 United States Issuing Office: Office of Human and Animal Food Operations - East Division 1 United States Secondary Issuing Offices United States Dear Mr. Onofrio: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 618502, issued on January 10, 2022 for your facility located at 222 Forbes Ave, New Haven, CT 06512. 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 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/ Latoya Griffith Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 07/15/2024 Regulated Product(s) Food & Beverages