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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Koenen Dairy Inc 6/5/12


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
P.O. Box 15905
Lenexa, Kansas 66214
Telephone: (913) 752-2100


June 5, 2012
Ref: KAN 2012-09
Gregory J. Koenen, President
Koenen Dairy Inc.
2070 360th Street
Hawarden, IA 51023
Dear Mr. Koenen:
An investigation of your dairy operation located in Hawarden, IA, by a Food and Drug Administration investigator on May 11-14, 2012, confirmed a market dairy cow, identified with back tag (b)(4) and house tag (b)(4), sold by you on or about January 30, 2012, for slaughter for human food to (b)(4), was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act.  USDA/FSIS analyses of tissues collected from that animal disclosed the presence of 39.11 parts per million (ppm) of tetracycline in the kidney. A tolerance level of 12 ppm has been established for residues of tetracycline in the kidney of cattle Title 21 Code of Federal Regulations Section 556.500. The presence of this drug in the kidney from this animal causes the food to be adulterated under Section 402(a)(2)(C)(ii) of the Act.  
In addition to the above violation, we are concerned that USDA/FSIS identified another recent cattle tissue residue associated with your operation. According to USDA, a dairy cow, identified with tag 931, sold by you and offered for slaughter for human food was found to have illegal levels of flunixin on October 27, 2011. As found and reported by USDA, the flunixin level found in the liver was 0.135 ppm and the tolerance is 0.125 ppm. The USDA letter dated November 22, 2011, which was sent to you, is enclosed with this letter.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records, you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals, and you failed to have a system to control administration of drug treatments to your animals. 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 above violations and to establish procedures whereby such 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 within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, 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 directed to Patrick L. Wisor, Compliance Officer, Food and Drug Administration, 11630 W. 80th St., Lenexa, Kansas 66214.  If you have any questions about this letter, please contact Compliance Officer Wisor at (913) 752-2730 or E-mail at patrick.wisor@fda.hhs.gov.
John W. Thorsky
District Director
Kansas City District