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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Millenkamp Cattle 12/14/09

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

December 14, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-07

William J. Millenkamp, Owner
Millenkamp Cattle
471 North 300 West
Jerome, Idaho, 83338

WARNING LETTER

Dear Mr. Millenkamp:

On September 2 and 4, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf-raising operation located at 471 North 300 West, Jerome, Idaho. 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 the 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 April 29, 2009, you sold a calf,  identified with complete back tag (b)(4), at (b)(4). The calf with back tag (b)(4) was sold and shipped directly to (b)(4). On or about April 30, 2009, (b)(4) slaughtered the calf with back tag (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the calf with back tag (b)(4) identified the presence of 0.28 parts per million (ppm) of penicillin residue in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues 9f penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510(a) (21 C.F.R. § 556.510(a)). 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 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 and adequate treatment records for the calf with back tag (b)(4). 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 drug PenOne Pro Penicillin G Procaine Injection (NADA 65-010). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 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 PenOne Pro Injection to the calf with back tag (b)(4) without following the indications, dosing instructions, and duration of treatment as stated in the drug's approved labeling. In addition, your extralabel use of PenOne Pro Injection was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a). Because your 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 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 or handler 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 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 Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Donovan at (425) 483-4946.

Sincerely yours,

/s/

Charles M. Breen
District Director