Meadowlark Dairy L.L.C. 2/13/12
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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
February 13, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 – 23
Virgil and Sandy Vande Hey
Dean Vande Hey
Todd Vande Hey
Terry Vande Hey
Meadowlark Dairy LLC
1074 Meadowlark Road
De Pere, Wisconsin 54115-9648
Dear Mssrs. and Mrs. Vande Hey:
On December 6 and 7, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1074 Meadowlark Road, De Pere, 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 August 10, 2011, you sold a dairy cow identified with your farm tags (b)(4) for slaughter as food. On or about August 11, 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 0.81 parts per million (ppm) and 5.9 ppm dihydrostreptomycin in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in 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 2.0 ppm for residues of dihydrostreptomycin in the uncooked edible kidney tissue of cattle as codified in 21 CFR 556.200. The presence of these drugs in edible tissue from this animal in these amounts 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 maintain complete treatment records and you failed 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 Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug (b)(4) brand of penicillin‑dihydrostreptomycin in oil. Specifically, our investigation revealed that you did not use (b)(4) brand of penicillin‑dihydrostreptomycin in oil as directed by its approved labeling. Use of this drug in this manner is an extra-label use. See 21 CFR 530.3(a).
The extra-label use of approved animal or human drugs in animals is allowed under the Act only if the extra-label use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) brand of penicillin‑dihydrostreptomycin in oil to your dairy cow identified with farm tags (b)(4) without following the dosage amount as stated in the approved labeling. Your extra-label use of (b)(4) brand of penicillin‑dihydrostreptomycin in oil was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extra-label use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
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 Brian D. Garthwaite, PhD, 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.
Joann M. Givens
Acting District Director
Minneapolis District Office