Comercial Mares de Chiloe

CLOSEOUT LETTER Comercial Mares de Chiloe MARCS-CMS 587913 — January 31, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Seafood/Seafood Product Recipient: Recipient Name Ignacio Samacoitz Comercial Mares de Chiloe Cardonal Bajo 2, 7 Lote 1A 5500000 Puerto Montt Los Lagos Chile Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) 5001 Campus Drive College Park , MD 20740 United States Dear Mr. Samacoitz: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #587913, issued August 19, 2019. 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/ Robyn R. Jones, Team Lead Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 02/18/2020 Regulated Product(s) Food & Beverages Seafood/Seafood Product