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  5. Magnus International Group - 482353 - 07/09/2019
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CLOSEOUT LETTER

Magnus International Group MARCS-CMS 482353 —

Product:
Animal & Veterinary
Recipient:
Recipient Name
Eric E. Lofquist
Recipient Title
President and CEO
Magnus International Group

679 Hardy Road
Painesville, OH 44077
United States

Issuing Office:
Center for Veterinary Medicine

6751 Steger Drive
Cincinnati, OH 45237
United States

(513) 679-2700

Dear Mr. Lofquist:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 482353 dated February 4, 2016. 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/
Stephen J. Rabe
Compliance Officer

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