| Public Health Service Food and Drug Administration |
Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214-3340 Telephone: (913) 752-2100 |
Department of Health and Human Services
June 15, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2011-10
Mr. Algene Houtsma, Majority Owner
Syracuse Dairy LLP
751 SE County Road 36
Syracuse, KS 67878
Dear Mr. Houtsma:
On April 19-21, and April 28, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 751 SE County Road 36, Syracuse, Kansas. 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].
Specifically, our investigation revealed that on or about November 29, 2010, you sold a dairy cow, identified with ear tag number (b)(4) for slaughter as food. On or about November 29, 2010, (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 presence of 0.383 ppm of flunixin in the liver tissue and 0.0489 ppm in the muscle tissue. FDA has established a tolerance of 0.125 ppm in the liver and 0.025 ppm in the muscle for residues of flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. § 556.286). The presence of this drug in edible tissues from 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)].
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 or 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.
Please send your response to Danial S. Hutchison, Compliance Officer, at the above address.
Sincerely yours,
/S/
John W. Thorsky
District Director
Kansas City District
Enclosure
cc:
Ken Bowers, Technical Specialist-ACAP
Kansas Dept. of Agriculture
P.O. Box 19282, Bldg. 282-Forbes Field
Topeka, KS 66619-0282
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