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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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J.B. Timmermann Farms Limited 02-Jun-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: 312-353-5863


 

June 2, 2006

WARNING LETTER
CHI-3-06

CERTIFIED MAIL
RETURN RECEIPT REOUESTE
D

Mr. David C. Timmermann, President
J.B . Timmermann Farms Limited
11601 S. Germantown Road
Breese, IL 62230

Dear Mr. Timmermann:

An investigation of your dairy operation located at 11601 S. Germantown Road, Breese, Illinois, conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 13 and 22, 2005, confirmed that you offered a dairy cow for sale for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs Terra-Vet 100 (Oxytetracyline hydrochloride Injection) and Sulfadimethoxine Injection 40% to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. 360b). You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.

On or about November 14, 2005, you consigned a dairy cow identified with ear tag 502 to [redacted] who assigned back tag number, [redacted] to this cow, so he could deliver the dairy cow to [redacted] for slaughter as food. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from that animal identified the presence of 0.59 parts per million (ppm) sulfadimethoxine in the liver tissue and 0.43 ppm sulfadimethoxine in the muscle tissue . A tolerance of 0.1 ppm has been established for negligible residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, subsection 556.640 (21 CFR 556.640). The presence of this drug in this amount in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)].

In addition, you adulterated the Terra-Vet 100 (Oxytetracyline hydrochloride Injection) and Sulfadimethoxine Injection 40% within the meaning of section 501(a)(5) [21U.S.C. 351(a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. "Extra label use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extra-label use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. 360b(a)] and 512(a)(5) [21 U.S.C. 360b(a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extra-label use of Terra-Vet 100 and Sulfadimethoxine Injection 40% failed to comply with these requirements.

For example, you administered a mixture of oxytetracycline and sulfadimethoxine to a dairy cow without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, your extra-label use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extra-label use of these drugs was not in compliance with 21 CFR Part 530, the drugs are unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act.

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 above violations and to establish procedures whereby such 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, state the reason for the delay and the timeframe 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. Richard Harrison, Director, Compliance Branch, at the above address. If you have any questions about this letter, please contact Mr. Harrison at the above address or by telephone at 312-596-4220.

Sincerely,

/S/

Scott J. MacIntire
District Director