LaMarquise Inc.

CLOSEOUT LETTER LaMarquise Inc. MARCS-CMS 558211 — October 15, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Tadeusz J. Wielezynski Recipient Title Owner LaMarquise Inc. 1550 W. Lane Avenue Upper Arlington , OH 43221-3921 United States Issuing Office: Cincinnati District Office 6751 Steger Drive Cincinnati , OH 45237 United States 513) 679-2700 Dear Mr. Wielezynski: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 558211, issued February 5, 2019. Based on our evaluation, it appears that you have addressed the violations 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/ Kimberly Dutzek Compliance Officer, Division V Office of Human and Animal Foods Operations-East Content current as of: 10/21/2019 Regulated Product(s) Food & Beverages