Taiyo Seafood New York, Inc.

CLOSEOUT LETTER Taiyo Seafood New York, Inc. MARCS-CMS 435696 — December 06, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Shou Xi Li Recipient Title President Taiyo Seafood New York, Inc. Taiyo Seafood New York, Inc. 38 Locust Street Brooklyn , NY 11206-4512 United States Issuing Office: Public Health Service 158-15 Liberty Avenue Jamaica , NY 11433 United States Dear Mr. Li: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2014-51 dated July 30, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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/ CDR Catherine M. Beer Director, Compliance Branch Office of Human and Animal Food Operations East – Division 1 Content current as of: 12/10/2018