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  5. Zunker, Andrew G. - 01/30/2015
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WARNING LETTER

Zunker, Andrew G. Jan 30, 2015

Zunker, Andrew G. - 01/30/2015

Product:
Animal & Veterinary

Recipient:
Zunker, Andrew G.


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 30, 2015
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                           
Refer to MIN 15 – 07
                           
 
Andrew G. Zunker, President
Valerie J. Zunker, Secretary
R & Z Farms, Inc.
N3011 Cloverland Road
Conrath, Wisconsin 54731
 
Dear Mr. and Ms. Zunker:
 
On December 3 and 4, 2014, the United States Food and Drug Administration (FDA), conducted an investigation of your dairy operation located at N3011 Cloverland Road, Conrath, 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 September 22, 2014, you sold a dairy cow, identified with back tag (b)(4) and bangle tag (b)(4), for slaughter as food. On or about September 23, 2014, (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 penicillin at 1.548 parts per million (ppm) in the kidney and detected the presence of oxyphenylbutazone, a metabolite of phenylbutazone, in the kidney.  FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), section 556.510(a), 21 CFR 556.510(a).  FDA has not established a tolerance for residues of oxyphenylbutazone, a metabolite of phenylbutazone, in the edible tissues of cattle. As such, there is no acceptable level of residue associated with the use of this drug in cattle. The presence of these drugs in edible tissues from this animal in these amounts 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 treatment records. 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 drugs (b)(4)™ (sterile penicillin G procaine injectable suspension, NADA (b)(4)) and Phenylbutazone (phenylbutazone tablets, USP, NADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. The use of these drugs 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)™ (sterile penicillin G procaine injectable suspension) to your dairy cow, identified with back tag (b)(4) and farm bangle tag (b)(4), without following the dosage amount, dosage amount per injection site, and slaughter withhold period as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of penicillin G procaine resulted in an illegal drug residue in violation of 21 CFR 530.11(d).
 
Our investigation also found that you administered Phenylbutazone (phenylbutazone tablets) to your dairy cow, identified with back tag (b)(4) and farm bangle tag (b)(4), without following the animal class as stated in the approved labeling.  Your extralabel use of phenylbutazone was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of phenylbutazone resulted in an illegal drug residue in violation of 21 CFR 530.11(c). Furthermore, phenylbutazone is prohibited for extralabel use in female dairy cattle 20 months of age or older by 21 CFR 530.41(a)(12).
 
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 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.
 
Our investigation also revealed that on or about September 22, 2014, you signed a (b)(4) “delivery ticket” certifying that the cow identified with farm bangle tag (b)(4) and found to have residues of penicillin and oxyphenylbutazone was “drug and bonemeal free.” Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h).
 
Please 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

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