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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Providence Dairy 31-Aug-05

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

Public Health Service
Food and Drug Administration
  Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


August 31, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. George E. Vander Dussen
Owner
Providence Dairy
353 County Road 19
Texico, NM 88135-9660

Ref. #: DEN-05-15

Dear Mr. Vander Dussen:

An investigation of your dairy operation located at 353. County Road 19, Texico, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on July 27 - 29, 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.

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act. Two dairy cows owned by your firm and sold at auction for slaughter for human food were found to contain illegal levels of drug residues by USDA testing.

On April 18, 2005, you consigned for sale a dairy cow, identified with ear tag [redacted] for slaughter as food at [redacted]. On or about April 19, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 4.80 parts per million (ppm) Sulfadimethoxine in the liver tissue and 2.03 ppm Sulfadimethoxine in the muscle tissue.

In addition, on June 8, 2005, you consigned for sale a dairy cow, identified with ear tag [redacted] for slaughter as food at [redacted]. On or about June 9, 2005, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 1.03 ppm Sulfadimethoxine in the liver tissue and 0.551 ppm Sulfadimethoxine in the muscle tissue.

A tolerance of 0.1 ppm has been established for residues of Sulfadimethoxine in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.640 (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 time frame 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 H. 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/

B. Belinda Collins
District Director