Inspections, Compliance, Enforcement, and Criminal Investigations
Hide A Way Dairy 8/10/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Denver District Office
6th Avenue & Kipling Street
August 10, 2011
Mr. Robert J. Vander Dussen
Hide A Way Dairy
563 Roosevelt Road 3
Portales, NM 88130
Dear Mr. Vander Dussen:
On April 11- 15, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 563 Roosevelt Road 3, Portales, 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 January 24, 2011, you consigned to (b)(4) a dairy cow for sale at auction for slaughter as food. The dairy cow, identified with ear tag (b)(4) was purchased by (b)(4) and slaughtered on January 25, 2011. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.311 parts per million (ppm) Sulfadimethoxine in the liver tissue, and 0.384 ppm Sulfadimethoxine in the muscle 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, Section 556.640, (21 CFR 556.640). The presence of this 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)].
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)].
We acknowledge receipt of your undated letter we received on April 26, 2011, responding to our form FDA 483, Inspectional Observations dated April 15, 2011. Your letter will be included in your permanent FDA file. Your response was inadequate in that you did not provide documentation of corrective actions you have taken.
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 be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
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.
Additionally, USDA/FSIS previously notified you by letters dated April 19, 2010, November 12, 2008 and September 22, 2004 of illegal Flunixin, Neomycin and Penicillin residues found in a bob veal calf and dairy cows you sold for slaughter for food.
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 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 email@example.com
Paul J. Teitell
Acting District Director