Milos Inc. dba Estiatorio Milos

CLOSEOUT LETTER Milos Inc. dba Estiatorio Milos MARCS-CMS 538563 — November 09, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Mr. Costas Spilliadis, Mr. George Spilliadis, Ms. Evridiki Spilliadis Recipient Title CEO and Co-owners Milos Inc. dba Estiatorio Milos 125 W. 55th Street New York , NY 10019 United States Issuing Office: New York District Office United States Dear Messrs. Spilliadis: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 538563 dated October 4, 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 Compliance Director Division of Northeast Imports-Compliance Branch U.S. Food and Drug Administration Content current as of: 11/29/2021 Regulated Product(s) Food & Beverages