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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Stoney Acres Calves 12/24/08

  

Department of Health and Human Services' logoDepartment 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

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
2009-DT-06

December 24, 2008

Mr. Shem P. Miller, Owner
Stoney Acres Calves
10500 West State Road 120
Shipshewana, Indiana 46565-9660

Dear Mr. Miller,

On October 6 and 8, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf growing operation located at 10500 West State Road, Shipshewana, Indiana 46565-9660. 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 three animals for slaughter that were 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 December 26, 2007, you sold a calf for slaughter as food. On December 28, 2007, (b)(4) slaughtered this animal. United Sates Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis (final analysis February 06, 2008) of tissue samples collected from this animal identified the presence of 0.152 parts per million (ppm) of flunixin in the liver. In addition, on or about January 9, 2008, you sold two calves for slaughter as food. On January 11, 2008, (b)(4) slaughtered these animals. USDA/FSIS analysis of tissue samples collected from the first calf identified the presence of 0.213 ppm of flunixin in the liver. USDA/FSIS analysis of tissue samples collected from the second calf identified the presence of 0.07 ppm of penicillin in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). FDA has established a tolerance of 0.0125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286. FDA has not established a tolerance for residues of flunixin in the edible tissues of non-formula fed veal calves. The presence of penicillin and flunixin in edible tissues from these animals 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, current treatment records for calves medicated by you do not reflect the route of administration, dosage used, and withdrawal periods. 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, penicillin and flunixin. Specifically, our investigation revealed that you did not use penicillin and flunixin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, 21 C.F.R. 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 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 penicillin to a calf without following the route of administration, as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered flunixin to calves without following the route of administration, as directed by your veterinarian. Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. 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 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.

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 had 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 directed to Judith A. Jankowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Jankowski at 313-393-8125 ; fax 313-393-8139; email judith.jankowski@fda.hhs.gov.

Sincerely,

/s/

Joann M. Givens
District Director
Detroit District