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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Zeis, Fred J 08-Sep-06

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Department of Health and Human Services' logo

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142



September 8, 2006

WARNING LETTER

Refer to MIN 06 - 37

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Fred J. Zeis
Owner
16881 400th Street
Avon, MN 56310

Dear Mr. Zeis:

Food and Drug Administration

An investigation of your dairy operation located in Avon, Minnesota, was conducted on June 22, 2006, by investigators from the Minnesota Department of Agriculture, acting on behalf of the U.S. Food and Drug Administration (FDA). This investigation 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 oxytetracycline hydrochloride injection to become adulterated within the meaning of section 501(a) (5) [21 U.S.C. 351(a) (5)] and unsafe under section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.

On or about January 30, 2006, you sold a dairy cow, identified with back tag 6585, for slaughter as food to [redacted]. On or about January 30, 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 that animal identified the presence of 43.58 ppm oxytetracycline in kidney tissue and 8.86 ppm oxytetracycline in muscle tissue.

A tolerance of 12 ppm in kidney and 2 ppm in muscle has been established for residues of oxytetracycline in edible tissues of cattle as codified in Title 21, Code of Federal Regulations , section 556.500 (21 CFR 556.500). The presence of this drug in these amounts in tissues from this animal 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. 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. 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)].

In addition, you adulterated oxytetracycline hydrochloride injection within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] 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) and 512(a)(5) of the Act and 21 CFR 530. Our investigation found that your extralabel use of oxytetracycline hydrochloride injection failed to comply with these requirements.

For example, you administered the oxytetracycline hydrochloride injection without following the animal class set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your extralabel use of this drug was not in compliance with 21 CFR 530, your use caused the drug to be unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

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 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.

Your written response should be sent to Brian D. Garthwaite, Ph.D., Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District