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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ward Thomas & Sons, Inc. 21-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Baltimore District Office

Central Region

6000 Metro Drive, Suite 101

Baltimore, MD 21215

Telephone: (410) 779-5454

FAX: (410) 779-5703

FE1 3003560585

02-BLT-14

February 21, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Lowell F. Thomas, President

Ward Thomas & Sons, Inc.

R.R. #5, Box 152

Bruceton Mills, West Virginia 26525

Dear Mr. Thomas:

The Food and Drug Administration (FDA) conducted an inspection of your dairy farm on January 23 and 24, 2002. The inspection revealed that you offered an animal for sale for slaughter as human food, in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Food, Drug and Cosmetic Act (FD&C Act).

On or about April 9, 2001 you sold a cow identified with back tag number [redacted] at the [redacted], where it was purchased by the [redacted] and slaughtered for use as human food. U.S. Department of Agriculture (USDA) analysis of tissue samples collected from that animal identified the presence the level of 18.47 ppm in the kidney tissues and 0.55 ppm in the liver tissues of the animal. A tolerance has not been established for residues o in the edible tissues of dairy cows as described in Title 21, Code of Federal Regulations (CFR), Part 556.300. 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 that may allow diseased animals and/or medicated animals bearing potentially harmful drug residues to enter the food supply. For example:

  • Your farm does not maintain medication/treatment records that identify the animal, the date of treatment, the drug used, the dosage administered, or the drug pre-slaughter withdrawal time.
  • Your farm does not segregate medicated animals to assure they are not sold for slaughter until the appropriate withdrawal time has been met.
  • You do not have a system for the review of treatment records prior to offering an animal for slaughter for human food that assures the drugs have been used only as directed, including following the labeled withdrawal time prior to slaughter.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the FD&C Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered to sale, to a slaughterhouse in interstate commerce is sufficient to hold you responsible for violations of the FD& C Act.

The above listed items are not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for assuring that your overall operations and the food you distribute are in compliance with the law. You should take prompt action to correct the 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.

Please 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 demonstrating that corrections have been made.

Your reply should be directed to Rosalie Bucey, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, telephone number (410) 779-5417.

Sincerely,

Lee Bowers

Director, Baltimore District