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CLOSEOUT LETTER

Lakeview Dairy, LLC MARCS-CMS 565303 —

Product:
Animal & Veterinary

Recipient:
Recipient Name
Michael D. Roecker, Bruce G. Walker
Recipient Title
Co-owners
Lakeview Dairy, LLC
Mayville Animal Clinic S.C., White Diamond Dairy, LLC

N8783 Basswood Road
Beaver Dam, WI 53916-9352
United States

Issuing Office:
Center for Veterinary Medicine

250 Marquette Avenue
Suite 600
Minneapolis, MN 55401
United States

612) 334-4100

Dear Messrs. Roecker and Walker:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 565303 dated October 19, 2018. 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/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations