Thai Union Group PLC

CLOSEOUT LETTER Thai Union Group PLC MARCS-CMS 630100 — September 08, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Ms. Wachira Katueang-Ngan Recipient Title Quality Manager Thai Union Group PLC 72/1 Moo 7 Sethakit 1 Road Tambon Tarsrai Amphoe Mueang Samut Sakhon 74000 Thailand Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States Dear: Ms. Wachira Katueang-Ngan: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 630100, issued April 20, 2022. Based on our evaluation, it appears 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. We note, you’re implementing your HACCP plan Frozen Precooked Tuna Loin for USA as written, however the monitoring frequency identified in the plan for the cooking temperature is inadequate. Please ensure the monitoring frequency is in compliance with 21 CFR 123. 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 Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 10/18/2022 Regulated Product(s) Food & Beverages