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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Paskewitz Cattle Company 28-Aug-01

DEPARTMENTOF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
Minneapolis District
240 Hennepin Avenue
Minneapolis MN S5401-1999
Telephone: 612-334-4100

August 28, 2001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 01-71

Thomas Paskewitz
Co-owner
Paskewitz Cattle Company
Redwood Counly Road 30, P.O. Box 202
Vesta, Minnesota 56292

Dear Mr. Paskewitz:

On July 13, 2001, an investigator from the Minnesota Department of Agriculture, acting on behalf of the Food and Drug Administration (FDA), inspected your cattle operation in Vesta, MN. That inspection found that two animals sold by you, for slaughter for human food, were in violation of Sections 402(a)(2)(c) (ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).

USDA/FSIS analysis of tissues collected from a dairy cow sold by you on or about November 24, 2000, to [redacted] disclosed the presence of penicillin at 0.07 ppm in the kidney and 0.10 in the kidney. USDA/FSIS analysis of tissues collected from a steer sold by you on or about January 4, 2001 to [redacted] disclosed the presence of penicillin at 0.41 ppm in the kidney and 0.22 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.

Our investigation 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, as noted in the form FDA-483 issued to you on July 13, 2001, your firm does not keep complete treatment records, you do not maintain treatment records for an appropriate period of time, and you do not record positive identification of treated animals. Foods from animals held under such conditions are adulterated.

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.

The violations listed above are not intended to be an all-inclusive list. It is your responsibility to ensure that your operations are in compliance with the law. To avoid future residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;

2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and

3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offer 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 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,

Director

Minneapolis District