3V Dairy 6/24/11

Department 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, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3100

June 24, 2011

WARNING LETTER

VIA UPS

Mr. Casey VanderDussen
Owner
3V Dairy
4205 South Graves Road
Roswell, NM 88203

Ref. #:  DEN-11-15-WL

Dear Mr. VanderDussen:

On May 10 – 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4205 South Graves Road, Roswell, New Mexico. 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 animals for sale for slaughter as food that were 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 May 25, 2010, you sold at auction, through (b)(4) , a dairy cow for slaughter as food to (b)(4). The dairy cow, identified with (b)(4), was slaughtered on or about May 26, 2010. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.55 parts per million (ppm) Penicillin in the kidney tissue, 0.26 ppm Penicillin in the Liver tissue, and 0.141 ppm Flunixin in the liver tissue.

FDA has established a tolerance of 0.05 ppm for residues of Penicillin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510, (21 CFR 556.510). FDA has established a tolerance of 0.125 ppm Flunixin in the liver tissue of cattle, as codified in 21 CFR 556.286. The presence of these drugs in the edible tissues of this animal in these amounts 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)].

In addition, our investigation revealed that on or about November 2, 2010, you sold at auction, through (b)(4), a dairy cow for slaughter as food to (b)(4). This dairy cow, identified with (b)(4), was slaughtered on or about November 3, 2010.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.08 parts per million (ppm) Penicillin in the kidney tissue. As noted above, the presence of this drug in the edible tissue of 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 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. In addition, you failed to maintain and review complete treatment records for medicated animals. 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 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, 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: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, CO  80225-0087.  If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at william.sherer@fda.hhs.gov  

Sincerely,

/s/

Paul J. Teitell
Acting District Director

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