Inspections, Compliance, Enforcement, and Criminal Investigations

Butterfield Dairy, LLC 7/8/15


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415


SIGNATURE REQUIRED                                                            
July 8, 2015
WL# 26-15
Mr. Thomas De Jong, Co-Owner
Mr. Andrew De Jong, Co-Owner
Mr. Jacob De Jong, Co-Owner
Mr. Thomas De Jong (Junior), Co-Owner
Butterfield Dairy, LLC
40001 West Old Highway 80
Buckeye, Arizona 85326-5105
Dear Messrs. De Jong:
On April 29, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 40001 West Old Highway 80, Buckeye, Arizona. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about January 29, 2015, you sold a (b)(4) cow, identified with ID (b)(4) and back tag # (b)(4) for slaughter as food.  On or about January 30, 2015, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.05 parts per million (ppm) of ampicillin in the kidney.  FDA has established a tolerance of 0.01 ppm for ampicillin in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.40 (21 C.F.R. § 556.40). The presence of this drug in edible tissue from this animal in this amount cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.                          
Please send your reply to the Food and Drug Administration, Attention: 
Daniel Cline, Acting Director
Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2506
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
Alonza E. Cruse, Director
Los Angeles District

Page Last Updated: 01/21/2016
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