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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Drake Dairy, Inc. 3/28/11


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

Public Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142


March 28, 2011
RETURN RECEIPT REQUESTED                           Refer to MIN 11 - 18
James B. Drake
President and Co-owner
Drake Dairy, Inc.
N8870 Drake Court
Elkhart Lake, Wisconsin 53020
Dear Mr. Drake:
On January 25 and February 14, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N8870 Drake Court, Elkhart Lake, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation.  You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
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 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 September 17, 2010, you consigned (b)(4) to haul your dairy cow (ear tag# (b)(4) indentified with back tag # (b)(4) for slaughter as food. On or about September 17, 2010, (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 ampicillin at 0.33 parts per million (ppm) in kidney. The FDA has established a tolerance of 0.01 ppm for ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.40, 21 CFR 556.40.  The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 have an effective system to control administration of drug treatments to your animals. Herdsmen have been authorized to administer drugs; but they failed to relay treatment information to the herd manager. You also failed to maintain complete treatment records that include the drug, dosage, route of administration, and withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
In addition to the above violation, we are concerned that USDA/FSIS identified another recent tissue residue associated with your dairy operation. Illegal levels of ampicillin and flunixin were found on October 20, 2009, in your dairy cow with ear tag #(b)(4) (back tag (b)(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 are 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.
We received an unsigned letter dated October 26, 2010, from Drake Dairy. The letter was post-marked February 17, 2011, and received in our office on February 22, 2011. The letter states that you have taken steps to help ensure that drug residue violations will not happen in the future. You made changes in your treatment protocols and record keeping, established a new communication system between the Herdsman and the Herd Manager, and are now entering all treatments into the (b)(4) computer system. We consider these to be necessary and appropriate corrective actions. However, your letter did not provide documentation that corrections have been implemented. Within 15 working days of receiving this letter, please provide our office with further documentation to substantiate your corrections. For example, provide copies of a representative sample of treatment records and any other records demonstrating that corrections have been made.
Your written response should be sent to Timothy G. Philips, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
Gerald J. Berg
Minneapolis District