Blue Pacifico S.A.C.

CLOSEOUT LETTER Blue Pacifico S.A.C. MARCS-CMS 501228 — June 05, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Seafood/Seafood Product Recipient: Recipient Name Byeong Joon Nam Recipient Title President Blue Pacifico S.A.C. Av. General Garzon 1283 Oficina 609, Jesus Maria Lima 23001 Tacna Peru tacnaof@bluepacifico-peru.com Issuing Office: Center for Food Safety and Applied Nutrition United States Dear Mr. Nam: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 501228, issued August 26, 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 Corpuz, Team Lead Food Adulteration and Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 06/10/2019 Regulated Product(s) Food & Beverages Seafood/Seafood Product