Balfego and Balfego, SL

CLOSEOUT LETTER Balfego and Balfego, SL February 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Balfego and Balfego, SL United States Issuing Office: United States College Park, MD 20740 February 9, 2018 Begonya Melich, Director of Technical Services Balfego and Balfego, S.L. Poligono Industrial Edificio Balfego Tarragona Provence L'ametlla De Mar, Spain 43860 Dear Begonya Melich: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 442297, issued November 14, 2014. 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. 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/ Maria G. Corpuz, Team Leader Food Adulteration and Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 02/12/2018