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New 88 Japanese Food Trading Inc MARCS-CMS 592644 —

Food & Beverages

Recipient Name
Mr. Shao Song (Kevin) Chen and Mr. David Chen
Recipient Title
President and Co-Owner/Vice-President and Co-Owner
New 88 Japanese Food Trading Inc

3305 Farrington Street
Flushing, NY 11354-2820
United States

Issuing Office:
Division of Human and Animal Food Operations East I

United States

Dear Messrs. Chen:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 592644 dated November 22, 2019. 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 subsequent inspection or through other means.

CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1

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