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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Goodrich Famrs LLP 16-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 56401-1999

Telephone: 612-334-4100

January 16, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 21

David W. Goodrich

Owner

Goodrich Farms, LLP

1947 - 220th Avenue

Deer Park, Wisconsin 54007

Dear Mr. Goodrich:

An investigation at your dairy farm located at Deer Park, WI, conducted by our investigators on January 2, 2002, confirmed that you offered an animal 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 50l(a)(5).

On or about October 26, 2001, you sold a cow (identified as cow #485 in your

records) for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin at 1.11 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (Title 21, Code of Federal Regulations, Part 556.510). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that 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 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. As noted in form FDA-483 issued to you on January 2, 2002, you did not follow the labeled withdrawal time of 10 days after treating your cow #485 with penicillin. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.

You are adulterating the penicillin drug that your firm uses on cows within the meaning of Section 50 1 (a)(5) when you fail to use the drug in conformance with its approved labeling. Your use of the drug 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 day 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 addressed to Compliance Officer Timothy G. Philips at the address on the letterhead.

Sincerely,

David R. Yost

Acting Director

Minneapolis District