| Public Health Service Food and Drug Administration |
Cincinnati District Office Central Region 6751 Steger Drive |
Department of Health and Human ServicesFebruary 18, 2010
VIA FEDERAL EXPRESS
WARNING LETTER
CIN-10-91184-04
Franciscus X.J. Van Genugten, Owner
Stardust Dairy, LLC
14997 Charleston Chillicothe Road
South Solon, OR 43153-9768
Dear Mr. Van Genugten:
On October 16 - November 20, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 14997 Charleston Chillicothe Road, South Solon OH. 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 FDA's web page at www.fda.gov.
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 20, 2009, you offered a cow with ear tag number (b)(4) for slaughter as food. On or about April 21, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the following:
Drug Tissue Residue Amount Tolerance Regulation
Flunixin Liver 0.1689 ppm 0.125 ppm 21 CFR 556.286
The presence of Flunixin in edible tissues from this animal above the established tolerance 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.
You lack an adequate inventory system (accounting and reconciliation) for determining the quantities of drugs used to medicate cows and you keep incomplete drug treatment records for the animals that you medicate. 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 01' 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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 ext 163 or at the address listed above.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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