Kronebusch Farms, Inc. 3/15/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
March 15, 2013
Via UPS OVERNIGHT
Refer to MIN 13 - 15
Daniel L. Kronebusch
President and Owner
Kronebusch Farms, Inc.
17803 Highway 248
Altura, Minnesota 55910
Dear Mr. Kronesbusch:
On January 15-16, 24-25, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17803 Highway 248, Altura, Minnesota. 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 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 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 August 7, 2012, you sold a dairy cow, identified with bangle tag (b)(4) and back tag (b)(4), for slaughter as food. On or about August 8, 2012, (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 0.47 parts per million (ppm) of penicillin in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), section 556.510 (21 CFR 556.510). 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 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 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 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.
Your written response should be sent to Pamela B. Schweikert, Director, Compliance Branch, Food and Drug Administration - Minneapolis District, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Ms. Schweikert at (612) 758-7112.
Michael Dutcher, DVM
xc: Doug Lueders
Minnesota Department of Agriculture
625 N. Robert Street
St. Paul, MN 55155-2538
USDA-FSIS District Office 25
Federal Building, Room 985
210 Walnut Street
Des Moines, Iowa 50309