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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jones Brothers Dairy LLC 22-Feb-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

February 22, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 26

Wayne L. Jones

President

Jones Brothers Dairy, LLC

1762 Highway 78s

Mount Horeb, Wisconsin 53572

Dear Mr. Jones:

An investigation at your dairy farm located at Mount Horeb, WI, conducted by our

investigator on January 9, 2002, confirmed that you offered animals for sale for slaughter as food in violation of Sections 402(a)(2)( c ii and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), and that you may have caused animal drugs to become adulterated within the meaning of Section 50 l(a)(5).

On or about November 15, 2001, you sold a dairy cow identified with back tag

number 35DP7368 to [redacted]. This animal was subsequently sold for slaughter as human food at [redacted] U.S. Department of Agriculture (USDA) analysis of tissue samples collected from this cow identified the presence of sulfadimethoxine at 4.09 ppm in the liver and 5.53 ppm in muscle. A tolerance of 0.1 ppm has been established for

residues of sulfadimethoxine in the edible tissues of cattle (Title 2 1, Code of Federal

Regulations, Part 556.640). The presence of this drug in edible tissue from this

animal causes the food to be adulterated.

Our investigation also found that you hold animals under conditions which are so

inadequate that diseased animals and/or medicated animals bearing potentially

harmful drug residues are likely to enter the food supply. For example, you lack

an adequate system for assuring that drugs are used in a manner not contrary to

the directions contained in the labeling and for assuring 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 tissue. As noted in

the form FDA-483 issued to you on January 9, 2002, you did not maintain records

of the treatment of dairy cows to avoid sale of animals bearing residual drugs in

edible tissues. Foods from animals held under such conditions are adulterated.

You are adulterating [redacted] brand of sulfadimethoxine that your firm uses on

dairy cattle within the meaning of Section 501 (a)(5) when you fail to use the drug in

conformance with its approved labeling. Your use of sulfadimethoxine in 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 caused the

adulteration of an animal that was sold and subsequently offered for sale to a

slaughterhouse that ships in interstate commerce is sufficient to hold you

responsible for a violation of the Act.

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 reply should be directed to Compliance Officer Timothy G. Philips at the

address indicated on the letterhead.

Sincerely,

David R. Yost

Acting Director

Minneapolis District