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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

James Schairer Farms, Inc. 12-Sep-01

DEPARTMENTOF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Minneapolis District
240 Hennepin Avenue
Minneapolis MN 55401-1999
Telephone: 612-334-4100

September 12, 2001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 01-74

James R. Schairer
President
James Schairer Farms, Inc.
N 1245 Evergreen Road
Birnamwood, WI 54414

Dear Mr. Schairer:

On June 13, 2001, investigators from the Food and Drug Administration (FDA) conducted an inspection at your dairy operation located in Birnamwood, WI. That inspection 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 501(a)(5).

On or about April 4, 2001, you sold a cow, identified with back tag number 35CS5079 for slaughter as human food to [redacted] United States Department of Agriculture (USDA) analysis of tissue samples collected from that animal identified the presence of 12.24 ppm gentamicin. No tolerance has been established for residues of gentamicin in the edible tissues of cows. 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 animals bearing potentially harmful drug residues are likely to enter the food supply. You admitted to treating dairy cattle with gentamicin in an extra-label manner for mastitis. As noted in form FDA-483 issued to you on June 13, 2001, you failed to maintain medication records to avoid unsafe residues. 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 chugs from edible tissues. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.

You caused the drug, gentamicin, to become adulterated within the meaning of Section 501 (a) (5) of the Act when you failed to use the drug in conformance with its labeling.

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 operations 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 occur. Failure to do so may result in regulatory action (such as seizure or injunction) without further notice to you.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be held responsible for a violation of the Act. The fact that you offered an animal 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 receipt of this letter of the steps you have taken to bring your dairy operation into compliance with the law. 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 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 that corrections have been made.

Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.

Sincerely,
James A. Rahto
Director
Minneapolis District