Masa NY, LLC

CLOSEOUT LETTER Masa NY, LLC MARCS-CMS 539271 — November 30, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 12/14/2021 Regulated Product(s) Food & Beverages