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  5. Masa NY, LLC - 539271 - 11/30/2021
  1. Warning Letters

CLOSEOUT LETTER

Masa NY, LLC MARCS-CMS 539271 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Masayoshi Takayama/Ms. Catherine Takayama
Recipient Title
Partner
Masa NY, LLC

10 Columbus Circle, 401
New York, NY 10019-1158
United States

Issuing Office:
New York District Office

United States

Dear Mr. Takayama & Ms. Takayama:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 539271 dated October 16, 2017. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration

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