Atum Do Brasil Captura Industria e Comercio

CLOSEOUT LETTER Atum Do Brasil Captura Industria e Comercio MARCS-CMS 491504 — October 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 491504 Product: Food & Beverages Seafood/Seafood Product Recipient: Recipient Name Mr. Mauro Lucio Pecanha de Almeida Recipient Title President Atum Do Brasil Captura Industria e Comercio Atum Do Brasil Captura Industria e Comercio Rua Sebastiao Alves de Almeida, No. 469 Praia de Itaoca Itapemirim - Brazil Issuing Office: Public Health Service United States 5001 Campus Drive College Park, MD 20740 October 17, 2018 Mr. Mauro Lucio Pecanha de Almeida President Atum Do Brasil Captura Industria e Comercio Rua Sebastiao Alves de Almeida, No. 469 Praia de Itaoca Itapemirim, Brazil Dear Mr. Pecanha de Almeida: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 491504, issued March 18, 2016. 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: 10/17/2018 Regulated Product(s) Food & Beverages Seafood/Seafood Product