Magnus International Group

CLOSEOUT LETTER Magnus International Group MARCS-CMS 482353 — July 09, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 07/10/2019 Regulated Product(s) Animal & Veterinary