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WARNING LETTER

Wild Rose Dairy, LLC

Product:
Animal & Veterinary

Recipient:
Wild Rose Dairy, LLC


United States

Issuing Office:
Minneapolis District Office

United States


   

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 

 

January 13, 2014
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                           
Refer to MIN 14 – 06
 
 
Arthur P. Thelen
Co‑Owner/President
Wild Rose Dairy, LLC
E11310 Buckeye Ridge Road
La Farge, Wisconsin 54639
 
Dear Mr. Thelen:
 
On November 19 and 20, 2013, the United States Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at E11310 Buckeye Ridge Road, La Farge, Wisconsin. 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 April 1, 2013, you sold a dairy cow identified with back tag # (b)(4) and farm bangle tag # (b)(4)) for slaughter as food. On or about April 1, 2013, (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 0.629 parts per million (ppm) of penicillin in kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked, edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, section 556.510(a), 21 CFR 556.510(a).  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 and to review complete treatment records to verify applicable withdrawal periods prior to offering the animal for slaughter as 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).
 
We also found that you adulterated the new animal drug (b)(4)® (Sterile Penicillin G procaine Injectable Suspension, NADA # (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. The use of this drug in this manner is an extralabel use as defined in 21 CFR 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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)® to the dairy cow identified with your farm bangle tag # (b)(4) without following the dose and amount per injection site as stated in the approved labeling. Your extralabel use of this drug was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and the extralabel 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 and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 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/
Michael Dutcher, DVM
Director
Minneapolis District
 
 
xc: David Abt
      Co‑Owner/Chief Financial Officer
      Wild Rose Dairy, LLC
      E11310 Buckeye Ridge Road
      La Farge, WI 54639
 
      Dustin Harris
      General Manager
      Wild Rose Dairy, LLC
      E11310 Buckeye Ridge Road
      La Farge, WI 54639

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