Inspections, Compliance, Enforcement, and Criminal Investigations

Leon Varel 8/22/16

  

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

Public Health Service
Food and Drug Administration
 
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187

 

August 22, 2016
 
WARNING LETTER
 
CHI-12-16
 
VIA UPS NEXT DAY
SIGNATURE REQUIRED
           
Leon Varel, Owner
Varel Farms, LLC
12201 Oil Field Rd.
Bartelso, IL 62218
 
 
Dear Mr. Varel:
 
On June 23, 2016 through June 29, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12201 Oil Field Rd, Bartelso, IL 62218. 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 2/18/2016, you sold a cow, identified with back tag (b)(4) for slaughter as food. On or about 2/19/2016, (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 desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue at a level of 21.47 ppm. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the edible tissues of a cow as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (b)(3)(i), (21 C.F.R. 556.113 (b) (3) (i)). 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 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 Lauren Crivellone, Compliance Officer, U.S. Food and Drug Administration, 550 W. Jackson Blvd., Chicago, IL 60661.  Refer to the Unique Identification Number (CMS# 501271). If you have any questions about this letter, please contact Ms. Crivellone via email at lauren.crivellone@fda.hhs.gov or by phone at (312) 596-4157.
 
 
Sincerely,
/S/
William R. Weissinger
District Director 
 
 
e-copy:           
Gerald Kirbach, Bureau Chief
Illinois Department of Agriculture
 
Paul Wolseley, District Manager
United States Department of Agriculture
Food Safety and Inspection Service

Page Last Updated: 09/22/2016
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