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CLOSEOUT LETTER

LaMarquise Inc. MARCS-CMS 558211 —

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