Amting Dairy Farm 3/4/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

WARNING LETTER
2011-DET-07

March 4, 2011
VIA UNITED PARCEL SERVICE
Mr. Bernardus H. Amting, Owner
Amting Dairy Farm
17451 N Drive N
Marshall, Michigan  49068

Dear Mr. Amting:

On December 16 and 29, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17451 N Drive N, Marshall, Michigan. 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 August 31, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about September 1, 2010, (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 sulfamethazine in the liver tissue at 0.268 parts per million (ppm). FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670). 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 complete 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 flunixin and oxytetracycline. Specifically, our investigation revealed that you did not use Suppressor (flunixin meglumine), ANADA 200-308, and Oxytet 100 (oxytetracycline hydrochloride), ANADA 200-452, as directed by their approved labeling. Use of these drugs in this manner is an extra label use, 21 C.F.R. 530.3(a).

The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra label 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 C.F.R. 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 flunixin to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the route of administration and the withdrawal period as indicated in its approved labeling. Your extra label use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 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).

In addition, our investigation found that you administered oxytetracycline to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the withdrawal period as indicated in its approved labeling. Your extra label use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 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 is 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 remind you that FDA has issued you a prior Warning Letter on August 29, 2003. A copy of this Warning Letter is provided for your review and information.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (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 fifteen (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 Mr. Michael V. Owens, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, Michigan 48207.  If you have any questions about this letter, please contact Compliance Officer Michael Owens at 313-393-8167 or E-mail at michael.owens@fda.hhs.gov.

Sincerely yours,
/s/
Joann M. Givens
District Director
Detroit District Office

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