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  5. Holdgrafer Dairy Inc. - 518298 - 02/22/2019
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CLOSEOUT LETTER

Holdgrafer Dairy Inc. MARCS-CMS 518298 —

Delivery Method:
UPS

Recipient:
Recipient Name
Scott L. Holdgrafer
Recipient Title
President and Owner
Holdgrafer Dairy Inc.
Holdgrafer Dairy Inc.

20070 328th Avenue
Bellevue, IA 52031
United States

Issuing Office:
Center for Veterinary Medicine

8050 Marshall Drive
Suite 205
Lenexa, KS 66214-1524
United States

913-495-5100

Dear Mr. Holdgrafer:

The Food and Drug Administration has completed an evaluation of Holdgrafer Dairy, Inc. corrective actions in response to our Warning Letter (CMS Case #: 518298) on March 11, 2017. 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West