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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Daniel W. Siegert 12/17/12

  

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

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, Kansas  66214-1524
 
Telephone:    (913) 495-5100

 

December 17, 2012
 
 
 
WARNING LETTER
UNITED PARCEL SERVICE
 
Ref. KAN 2013-03
 
Daniel W. Siegert, Operations Manager
Siegert Swiss
17417 North Cascade Road
Peosta, IA 52068
 
Dear Mr. Siegert:
 
On November 14 through November 16, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17417 North Cascade Road, Peosta, Iowa. 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 animals 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 August 28, 2012 you sold a dairy cow, identified as (b)(4) for slaughter as food. On or about August 29, 2012, (b)(4) located in (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 5.5 ppm of Desfuroylceftiofur in the kidney. Desfuroylceftiofur is a marker residue of the drug Ceftiofur. FDA has established a tolerance of 0.4 ppm for the marker residue Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. § 556.113). The presence of Desfuroylceftiofur in edible tissue from 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).
 
Additionally, our investigation revealed that on or about September 6, 2012, you sold a second dairy cow, identified a(b)(4) for slaughter as food. On or about September 8, 2012, (b)(4) located in (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this anima lidentified the presence of 2.42 ppm of Desfuroylceftiofur in the kidney. Desfuroylceftiofur is a marker residue of the drug Ceftiofur. FDA has established a tolerance of 0.4 ppm for the marker residue Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.P.R.), 556.113 (21 C.P.R. §  556.113).The presence of Desfuroylceftiofur in edible tissue from 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 complete treatment records.  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 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.
 
Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Lenexa, KS 66214.  If you have any questions about this letter, please contact Compliance Officer Hutchison at (913) 495-5154.
 
Sincerely yours,
/S/
John W. Thorsky
District Director
Kansas City District 
 
 
cc:    
Steve Moline, Bureau Chief
IDALS
Wallace State Office Building
502 E. 9th Street
Des Moines, IA 50319
 
Judd D. Grover, DVM
TriVet Associates
902 1st st NW.
Farley, IA 52046