CLOSEOUT LETTER

Double W. Dairy September 29, 2014

Recipient:: Double W. Dairy; United States

Issuing Office:: United States


Department of Health and Human Services
	Food and Drug Administration Denver District Office Building 20 - Denver Federal Center P.O. Box 25087 Denver, Colorado 80225-0087 TELEPHONE: 303-236-3000

September 29, 2014

Mr. Marc A. Wailes, Co-Owner
Double W. Dairy, LP
416 S. Campbell
Holyoke, Colorado 80734-9313

Dear Mr. Wailes:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-13-22-WL, dated September 26, 2013. 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/

LaTonya M. Mitchel
District Director
Denver District

cc: Mr. Greg K. Wailes, Co-Owner
      Double W Dairy, LLC
      416 S. Campbell
      Holyoke, Colorado 80734-9313

      Mr. Glenn D. Huwa, Co-Owner
      Double W. Dairy, LP
      416 S. Campbell
      Holyoke, Colorado 80734-9313

Department of Health and Human Services