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  5. Burren Smokehouse Ltd. - 584335 - 04/06/2020
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Burren Smokehouse Ltd. MARCS-CMS 584335 —

Recipient Name
Ms. Birgitta Hedin Curtin
Recipient Title
Managing Director
Burren Smokehouse Ltd.

Kincora Road
Co. Clare
V95 HD70

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.

Robyn R. Jones
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance

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