Dexter Dairy 07-Oct-05

Dear Mr. Villalpando, Sr. :

An investigation of your dairy operation located at 7361 Vineyard Road, Dexter, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on July 26 - August 2, 2005, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On January 5, 2005 you consigned for sale a dairy cow, identified with ear tag # 6706, for slaughter as food at [redacted]. On or about January 6, 2005, the animal identified with ear tar; # 6706 was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.298 parts per million (ppm) Flunixin in the liver tissue.

In addition, on February 21, 2005, you consigned for sale a dairy cow, identified with ear tag # 1824, for slaughter as food at [redacted]. On or about February 22, 2005, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.979 ppm Sulfadimethoxine in the liver, 0.55 ppm Sulfadimethoxine in the muscle tissue and 0.291 Flunixin in the liver tissue.

A tolerance of 0.125 ppm has been established for residues of Flunixin in edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 CFR 556.286). The presence of this drug in edible tissues from these animals in amounts exceeding the tolerance set out in 21 CFR 556.286 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)]. A tolerance of 0.1 ppm has been established for residues of Sulfadimethoxine in the edible tissues of cattle, as codified in 21 CFR 556.640. The presence of this drug in edible tissues from these animals in amounts exceeding the tolerance set out in 21 CFR 556.640 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 could allow medicated animals bearing potentially harmful drug residues to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records of the quantities of drugs used to medicate your dairy cows and the dates of administration of these drugs. 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 foods 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 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, state the reason for the delay and the timeframe within which the corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made.

Your written response should be sent to: William Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Mr. Sherer at (303) 236-3051 if you have any questions about this matter.

Sincerely,
/s/
Howard E. Manresa Acting for B. Belinda Collins
District Director