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CLOSEOUT LETTER

Allandale Dairy MARCS-CMS 582496 —

Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
Scott A. Stangl, Shane Stangl, Craig Stangl
Recipient Title
Co-owner
Allandale Dairy

27231 83rd Street
Pierz, MN 56364-7634
United States

Issuing Office:
Office of Human and Animal Food Operations

United States

(612) 334-4100

Dear Messers Stangl:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 582496 dated June 13, 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/

Dianna C. Sonnenburg

Compliance Officer, HAF-W1 CB

Office of Human and Animal Food Operations

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