Pulmuone Foods USA, Inc.

CLOSEOUT LETTER Pulmuone Foods USA, Inc. MARCS-CMS 416366 — September 30, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Seafood/Seafood Product Recipient: Recipient Name Hyoyul Lee Recipient Title North American Business Unit CEO Pulmuone Foods USA, Inc. 2315 Moore Ave Fullerton , CA 92833 United States Issuing Office: Office of Human and Animal Food Operations – West Division 5 1201 Harbor Bay Parkway Alameda , CA 94502 United States Dear Hyoyul Lee: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated February 6, 2014. 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. Sincerely, /S/ For: Darla R. Bracy District Director | FDA San Francisco District Program Division Director Office of Human and Animal Food Operations – West Division 5 Content current as of: 10/04/2019 Regulated Product(s) Food & Beverages Seafood/Seafood Product