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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Thiele Dairy 29-Mar-07

Department 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

March 29, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref: KAN 2007-05

William L. Thiele, Co-owner
Thomas J. Thiele, Co-owner
Ronald J. Thiele, Co-owner
Thiele Dairy
84925 515th Ave
Clearwater, Nebraska 68726-5287

Dear Messrs. Thiele:

An inspection of your dairy operation located at 84925 515th Ave, Clearwater, Nebraska conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 10, 2007 and January 17, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug gentamicin to be unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about October 18, 2006, you consigned a cow identified with Thiele Dairy ear tag #4093 for slaughter as food to [redacted] On or about October 18, 2006, this animal was slaughtered at [redacted] The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney tissue of this animal, amount not quantified. No tolerance has been established for gentamicin in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.300 (21 C.F.R. 556.300). The presence of this drug in the kidney tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

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 complete treatment records that contain the amount of the drug you used, the route it was administered, and the withdrawal time for meat and milk. You also lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.

In addition, you adulterated gentamicin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use this drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Actand 21 C.F.R. Part 530. Our investigation found that your extralabel use of gentamicin failed to comply with these requirements.

For example, you administered gentamicin without following your veterinarian's written instructions for type of animal and for withdrawal time and you did so without consulting your veterinarian, i.e., without the supervision of a licensed veterinaian, in violation of 21 C.F.R.530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with the approved labeling or 21 CFR Part 530, your use caused the drug to be unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

We note that this is not the first time an illegal drug residue has been found in a cow owned by you. On February 27, 2006, USDA/FSIS collected a sample (477408) which tested positive for the presence of gentamicin residues (amount not quantified) in the kidney and liver tissues collected from a cow identified [redacted] back tag number 3557.

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 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, 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. Please direct your reply to Amy E. Devine, Acting Compliance Officer, at the address listed above.

Sincerely,

/S/

John W. Thorsky
District Director
Kansas City District

cc: Dr. Dennis Hughes, State Veterinarian
Nebraska Department of Agriculture
Bureau of Animal Industry
P.O. Box 94787
Lincoln, NE 68509-4787

Isabel Arrington, Ph.D., VMO
Director, Technical Assistance/Correlation
USDA Technical Service Center
1299 Farnam St., Suite 300
Omaha, NE 68102

Mr. Dennis Greening, District Manager
USDA/FSIS District Office
Room 985 Federal Building
210 Walnut St.
Des Moines, IA 50309

Dr. Gregg A. Hanzlicek
Bovine Production Services, LLC
47502 853rd Road
Amelia, Nebraska 68711