Gate Gourmet Inc.

CLOSEOUT LETTER Gate Gourmet Inc. MARCS-CMS 543440 — May 14, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Gate Gourmet Inc. United States Issuing Office: United States Cincinnati District Office 6751 Steger Drive Cincinnati, OH 45237 Telephone: (513) 679-2700 FAX: (513) 679-2772 May 14, 2018 Dawn M. Sanchez, General Manager Gate Gourmet, Inc. 3298 Lincoln Road Unit 117 Erlanger, Kentucky 41018 Dear Ms. Sanchez: The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 543440, where a "Provisional" status was given to your firm. Based on our re-inspection of your facility on April 24 and 26, 2018, it appears you have addressed the violations contained in this warning letter. Therefore, the classification is being changed to "Approved." We acknowledge your response dated April 11, 2018, addressing corrective actions to the violations cited on the Form FDA 483, issued to you on April 26, 2018. Your corrective actions to the cited violations appear adequate. 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/ Kimberly A. Dutzek Compliance Officer, Division V Office of Human and Animal Foods Operations-East Content current as of: 06/25/2018