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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Box Canyon Dairy 3/6/12

  

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

March 6, 2012
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply, refer to Warning Letter, SEA 12-16

Thomas Heida, Partner
Box Canyon Dairy
P.O. Box 140
Wendell, Idaho 83355

WARNING LETTER

Dear Mr. Heida:
 

On November 1-2, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1600 East 3490 South, Wendell, Idaho. 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 April 30, 2011 , you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4) for slaughter as food. On or about May 4, 2011 (b)(4), located at (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 0.25 parts per million (ppm) of sulfadimethoxine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Part 556.640 (21 C.F.R. 556.640). 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 drug Di-Methox Injection ANADA 200-038 (sulfadimethoxine). Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug 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 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 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 sulfadimethoxine to a dairy cow with back tag (b)(4) and ear tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41 (a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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 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.

FDA acknowledges your firm's written response we received following our inspection. A letter dated November 4, 2011, was received addressing the observations made during the inspection we conducted at your firm. Although your letter indicates that your firm has taken steps to address our observations, your response is not completely adequate. Your response does not address how your firm will monitor the individual in charge of the hospital in order to prevent future violations from occurring. Although you revised your protocols, your response failed to address how the new protocol will be implemented, how employees administering the medications will be retrained, or how your firm will insure that the correct version of the protocol is used in your hospital pen.

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 Jessica L. Kocian, Acting Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021. If you have any questions about this letter, please contact Acting Compliance Officer Jessica Kocian at 425-302-0315.

Sincerely,

/s/

Charles M. Breen
District Director
Seattle District

 

cc: Jerimy Craig, Partner
     P.O. Box 140
     Wendell, ID 83355

     Jeannie Wolverton, Partner
     P.O. Box 140
     Wendell, ID 83355

     Frans Aardema, Partner
     P.O. Box 140
     Wendell, ID 83355 

     Dawna Ciocca, Partner
     P.O. Box 140
     Wendell, ID 83355 

     (b)(4)

    Debra M. Lawrence, DVM
    Idaho State Department of Agriculture
    Division of Animal Industries
    P .0. Box 7249
   Boise, ID 83707