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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Van Ess Dairy LLC 6/4/12

  

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

Public Health Service
Food and Drug Administration
 
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
 
Telephone:    (913) 752-2100 

 

                                                                                                                     
June 4, 2012
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
Ref: KAN 2012-08
 
Harvey W. VanEss, President
VanEss Dairy LLC
2996 Sorrel Avenue       
Sanborn, IA 51248-7477
 
Dear Mr. VanEss:
 
On May 7-10, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2996 Sorrel Ave. Sanborn, IA 51248. 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 December 1, 2011, you sold a cow, identified with bangle tag # (b)(4) for slaughter as food.  On or about December 7, 2011, (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 penicillin at 0.41 parts per million (PPM) in the kidney 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 (C.F.R.), 556.510 (21 C.F.R. § 556.510). The presence of these drugs 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.
 
Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 11630 W. 80th Street, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at (913) 752-2774.
 
 
Sincerely yours,
/S/
John W. Thorsky
District Director
Kansas City District Office
 
 
Enclosure
 
cc: 
Kevin E. Klommhaus, Bureau Chief
Feed & Fertilizer Bureau
Iowa Department of Agriculture & Land Stewardship
Wallace Building
502 East 9th Street
Des Moines, Iowa 50319