| 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 |
Department of Health and Human ServicesSeptember 15, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 -53
Dear Mssrs. Rausch:
On May 25 and 27, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 920 E. Townline Road, Athens, WI. 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 animals 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 March 14,2011, you sold a dairy cow identified with your farm tag (b)(4) for slaughter as food. On or about March 14, 2011, (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 desfuroylceftiofur at 16.68 parts per million (ppm) in the kidney and 0.152 ppm of flunixin in the liver.
Furthermore, our investigation revealed that on or about December 6, 2010, you sold a dairy cow identified with your farm tag (b)(4) for slaughter as food. On or about December 6, 2010, (b)(4) slaughtered this animal. The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 17.58 ppm in the kidney.
FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.113(b)(3)(i), 21 CFR 556.113(b)(3)(i) and a: tolerance of 0.125 ppm for residues of flunixin in the uncooked edible liver tissue of cattle, 21 CFR 556.286(b)(1)(i). The presence of these drugs in these tissues from these animals in these concentrations 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, and you failed to systematically review treatment records to assure that withdrawal times were observed prior to offering an animal for slaughter for human food. 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 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.
The investigator discussed with you during the inspection your use of (b)(4) (brand of lincomycin-spectinomycin soluble powder) in a foot spray to treat hairy hoof warts. You committed to discussing with your veterinarian your use of this drug by prescription and under the supervision of your veterinarian.
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.
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
Sincerely,
/S/
Gerald J. Berg
Director Minneapolis District
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