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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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J & V Dairy, LLC


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

October 14, 2009


In reply refer to Warning Letter SEA 10-03

Joe S. Lopez, President
J & V Dairy, LLC
602 West 620 North
Shoshone, Idaho 83352


Dear Mr. Lopes:

On August 20 and 24, 2009, the U.S. Food and Drug Administration (FDA) conducted an
investigation of your dairy operation located at 604 West 620 North, Shoshone, 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

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 10, 2009, you sold a dairy
cow, identified with Back Tag number (b)(4) and Ear Tag number (b)(4), for slaughter
as food to (b)(4), where they were subsequently slaughtered on that same day. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine at 26.52 parts per million (ppm) in the liver. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640). The presence of sulfadimethoxine in edible tissues 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 segregate treated animals, so as to preclude them
from being sent to slaughter before proper medication withdrawal times could be observed,
and 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 Act, 21 U.S.C.
§ 342(a)(4).

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 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) 483-4940.

Sincerely yours,
Charles M. Breen
District Director