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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Hildebrandt Farms 9/12/11

  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

 

September 12, 2011
 
WARNING LETTER
 
CHI-17-11
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Mr. Kenneth W. Hildebrandt, Co-Owner             
Mr. Donald F. Hildebrandt, Co-Owner
Hildebrandt Farms                                     
2475 Stateline Road / 2587 Stateline Road
South Beloit, Illinois 61080   
 
Dear Messrs Hildebrandt:
 
On June 2 and July 19, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2587 Stateline Road, South Beloit, Illinois. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under Section 402(a)(4) of the FD&C 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 December 30, 2010, you sold a cull dairy cow identified with back tag #(b)(4) for slaughter as food. On or about December 31, 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 7.87 parts per million (ppm) of desfuroyceftiofur in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113). The presence of this drug 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 FD&C 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 FD&C 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 are 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 Richard Harrison, Director, Compliance Branch, at the address of the letterhead. If you have any questions about this letter, please contact Mr. Harrison at 312-596-4220 or via e-mail at Richard.Harrison@fda.hhs.gov.
 
Sincerely,
/S/ 
Scott J. MacIntire
District Director
 
cc:       
Illinois Department of Agriculture
Bureau of Animal Health
State Fairgrounds - P.O. Box 19281
Springfield, Illinois 62794-9281
 
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Program and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff