Middle East Bakery, Inc.

CLOSEOUT LETTER Middle East Bakery, Inc. MARCS-CMS 433344 — October 15, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Recipient: Recipient Name Joseph J. Boghos Recipient Title President Middle East Bakery, Inc. Middle East Bakery, Inc. 30 International Way Lawrence , MA 01843 United States Issuing Office: New England District Office One Montvale Avenue, 4th floor Stoneham , MA 02180 United States Dear Mr. Boghos: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 433344, September 18, 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 of Compliance Office of Human and Animal Food Operations East – Division 1 Content current as of: 10/30/2018