Inspections, Compliance, Enforcement, and Criminal Investigations
Templeton Dairy LLC 3-27-2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
Telephone: (612) 758-7132
March 27, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09-15
Richard L. Templeton
Donald P. Templeton
Templeton Dairy, LLC
9743 N. Evansville Brooklyn Road
Evansville, Wisconsin 53536-9244
Dear Mssrs. Templeton:
On January 15 and 30, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9808 N. Evansville Brooklyn Road, Evansville, Wisconsin. This letter notifies you of the 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 25, 2008, you consigned a dairy cow identified with your farm tag (b)(4) for sale for slaughter as food. On or about September 25, 2008, (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 0.23 parts per million(ppm) in kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of 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)(u)]
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 that include the dosage amount, route of administration, and the withholding period for drugs administered to the cattle 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)).
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.
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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. 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.
W. Charles Becoat
xc: Dr. Craig White
2810 Crossroads Drive, Suite 3500
Madison, WI 53718-7969