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WARNING LETTER

Rindts Wolf River Dairy, LLC 21/04/2016

Rindts Wolf River Dairy, LLC - 04/21/2016


Recipient:
Rindts Wolf River 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

 

April 21, 2016
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                     
Refer to MIN 16 - 11
                                                                     
 
Reagan M. Rindt, Co-Owner
Michael Rindt, Co-Owner
Rindts Wolf River Dairy, LLC
N3322 County Road CC
Shawano, Wisconsin  54166-6719
 
Dear Messrs. Rindt:
 
On January 22 and February 9, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at N3322 County Road CC, Shawano, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection 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 23, 2015, you sold a lactating dairy cow with backtag #(b)(4) for slaughter as food. On or about September 24, 2015, (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 0.06 parts per million (ppm) of ampicillin and the presence of tulathromycin in the kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.40 (21 CFR 556.40). FDA has established a tolerance of 5.5 ppm for residues of tulathromycin in the edible liver tissue of cattle, as codified in 21 CFR 556.745(b)(1)(i). However, there is no approved use of tulathromycin in female dairy cattle 20 months of age or older. 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 treatment records and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 drugs (b)(4) (tulathromycin, NADA (b)(4), and (b)(4) (flunixin meglumine, ANADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or veterinary prescription. The use of these drugs in this manner is extralabel use. See 21 CFR 530.3(a). 
 
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel 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) to the lactating dairy cow identified with backtag # (b)(4), without following the animal class as stated in the approved labeling or the veterinary prescription. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). In addition, our investigation found that you administered (b)(4) to your heifer dairy calves without following the route of administration as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs 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.
 
We have received your response postmarked February 18, 2016, in response to the form FDA-483 issued on February 9, 2016.  This response is inadequate, as it does not provide any documentation of the new protocol. Your letter has been made a part of the Minneapolis District’s permanent file for your firm.
 
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 Dianna C. Sonnenburg, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Ms. Sonnenburg at (612) 758-7125.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District
 

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