CLOSEOUT LETTER
4-Way Dairy, LLC
- Recipient:
- 4-Way Dairy, LLC
United States
- Issuing Office:
United States
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| Food and Drug Administration Denver District Office Building 20-Denver Federal Center P.O. Box 25087 Denver, Colorado 80225-0087 TELEPHONE: 303-236-3000 |
Department of Health and Human Services
May 6, 2014
Mr. Callen D. Mitchell, Co-Owner
4-Way Dairy, LLC
493 New Mexico 467
Portales, NM 88130
Dear Mr. Mitchell:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-13-12-WL, dated April 12, 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/
Sarah A. Della Fave
Compliance Officer
Denver District
cc: Ms. Demarys L. Mitchell
4-Way Dairy, LLC
493 New Mexico 467
Portales, NM 88130
Mr. Ronnie Mitchell
4-Way Dairy, LLC
493 New Mexico 467
Portales, NM 88130
Ms. Sybil Mitchell
4-Way Dairy, LLC
493 New Mexico 467
Portales, NM 88130