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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Walker Farms 29-Jun-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771


VIA FEDERAL EXPRESS

June 29, 2004

Duaine E. Walker, Owner
Kenneth D. Walker, Owner
Walker Farms
3093 Anderson Avenue NE
Minerva, OH 44657

WARNING LETTER CIN-04-22024

Dear Mr. Walker:

An inspection of your dairy farm located in Minerva, Ohio by Food and Drug Administration (FDA) Investigator Mishelle L. Harriger from 4/30/2004 - 5/6/2004 confirmed that you offered an animal for sale as human food in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animal (a bob veal calf) was adulterated food within the meaning of sections 402(a)(2)(C)(ii) and 402(a)(4) of the ACT.

The United States Department of Agriculture (USDA)/Food Safety Inspection Service (FSIS) analyses of tissues collected from the animal disclosed the presence of the following drugs:

Animal ID Drug Tissue Level Tolerance
         
Back Tag 262 Neomycin Muscle detected None Established
  Neomycin Kidney 88.24ppm None Established
  Penicillin Kidney 0.06ppm None Established

Tolerance levels for residues of new animal drugs are found in Title 21, Code of Federal Regulations (CFR), Part 556. There are no established tolerances for either Neomycin or Penicillin in bob veal calves. As such, the presence of these drugs in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

The investigation also found that you hold animals under conditions that could allow medicated animals, bearing potentially harmful drug residues, to enter the food supply. For example:

  • You do not maintain written records demonstrating that animals that have received medications have been withheld from milk production or withheld from slaughter for the number of days indicated on the drug’s label.
  • You do not segregate animals that have been treated with medications from the rest of the herd.
  • You do not have a record of the medications that you purchase or use.

Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act.

We also note that the [redacted] Auction has on file a certificate (or guarantee ) from your firm stating that the animals that you sell there do not contain any illegal drug residues. If you continue to medicate animals without maintaining the records and procedures listed above, you may be giving a false guarantee. Giving a false guarantee is prohibited by section 301(h) of the Act.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to correct the violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.

The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law.

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 caused the adulteration of an animal that was 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 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 Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097, Attention: Stephen J. Rabe, Compliance Officer.

Sincerely,

/s/

Carol A. Heppe
District Director
Cincinnati District Office