Burren Smokehouse Ltd.

CLOSEOUT LETTER Burren Smokehouse Ltd. MARCS-CMS 584335 — April 06, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Ms. Birgitta Hedin Curtin Recipient Title Managing Director Burren Smokehouse Ltd. Kincora Road Lisdoonvarna Co. Clare V95 HD70 Ireland Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) 5001 Campus Drive College Park , MD 20740 United States Dear Ms. Curtin: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #584335 July 30, 2019. 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/ Robyn R. Jones Food Adulteration Assessment Branch Division of Enforcement Office of Compliance Content current as of: 04/13/2020