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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Duescher Hilltop Jerseys 06-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 55401-1999

Telephone: 612-334-4100

March 6, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 28

Loren A. Duescher

Co-owner

Duescher Hilltop Jerseys

E3470 Highway F

Kewaunee, Wisconsin 54216

Dear Mr. Duescher:

An investigation at your dairy farm conducted by our investigator on January 23-

24, 30 and February 13, 2002, revealed that you have caused animal drugs to

become adulterated within the meaning of Section 501(a)(5) of the Federal Food,

Drug, and Cosmetic Act (the Act).

On or about December 10, 200 1, you sold a dairy cow identified with back tag

number 35DK3982 for slaughter as human food [redacted]. U.S. Department of Agriculture (USDA) analysis of tissue samples collected from this cow identified the presence of neomycin at 32.38 ppm in the kidney. A tolerance of 7.2 ppm has been established for residues in the edible tissue of cattle (Title 21, Code of Federal Regulations, Part 556.430).

You are adulterating w brand of neomycin sulfate that your firm administers to dairy cattle within the meaning of Section 50l(a)(5) when you fail to use the drug in conformance with its approved labeling. Your administration of neomycin sulfate to dairy cattle either at higher than labeled dosages or without following the labeled withdrawal period causes the drug to be unsafe to use.

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 foods 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.

It is not necessary for you to personally ship an adulterated animal in interstate

commerce to be responsible for a violation of the Act. The fact that you adulterated

a drug that had been shipped in interstate commerce is sufficient to hold you

responsible for a violation of the Act.

Please 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 reply should be directed to Compliance officer Timothy G. Philips at the above

address.

Sincerely,

James A. Rahto

Minneapolis District