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  5. Euro USA, Inc. - 666173 - 09/17/2024
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CLOSEOUT LETTER

Euro USA, Inc. MARCS-CMS 666173 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Joseph O’Donnell
Recipient Title
Chief Executive Officer
Euro USA, Inc.

4481 Johnston Parkway
Cleveland, OH 44128
United States

duff@eurousa.com
Issuing Office:
Division of Human and Animal Food Operations East V

United States

Secondary Issuing Offices

United States

Dear Mr. O’Donnell:

The Food and Drug Administration has completed an evaluation of Euro USA, Inc. corrective actions in response to our Warning Letter 666173, dated November 22, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Further 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/
Allison C. Hunter
Compliance Officer
Office of Human and Animal Food Operations
East 5 Division

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