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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Double J Livestock 26-Jul-04

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 7711~5454


 

FEI:3004372058

04-BLT-26

July 26, 2004

WARNING LETTER

CERTIFIED MAIL
RETURNRECEIPT REQUESTED

Mr. James V. Housden D.B.A.
Double J Livestock
P.O. Box 57
MountCrawford, Virginia 22841

Dear Mr. Housden:

An inspection of your dairy operation located in Mount Crawford, Virginia, by the Food and Drug Administration on February 4, 20, and 25, 2004, confirmed that a dairy cow you offered for sale for slaughter as food was adulterated within the meaning of Section 402(a)(2)(C)(ii) and Section 402(a)(4 of the Federal Food, Drug, and Cosmetic Act (the Act). Introducing adulterated food into interstate commerce is a prohibited act under Section 301(a) of the Act.

The inspection confirmed that you offered a dairy cow identified with backtag [redacted] for sale for slaughter as food [redacted] on 8128103. USDA/FSIS analysis of tissues collected from that animal disclosed 1.14 ppm of flunixin in the animal's kidneys. There is no established tolerance for flunixin in the kidney tissues of cattle. [21 CFR 556.286] This deficiency causes the drug to be adulterated within the meaning of Section 501(a)(5) of the Act.

Our investigation also found that you hold animals under conditions which 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 fail to have a system in place to identify drug used, dates of treatment, dosages administered, route of administration, and drug withdrawal times when treating 'animals or purchasing medicated animals; you lack a system for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues; and you lack a system to properly identify and/or segregate medicated livestock. Food from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.

In addition, you used a human prescription drug, Sulfamethoxazole and Trimethoprim Tablets, (USP, 800mg/160 mg) for the treatment of scours in feeder calves without a lawful order from a licensed veterinarian and without benefit of a valid veterinary client-patient relationship. This drug also lacked directions for extra label, animal use. This causes these animals to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act and misbranded within the meaning of 502(f) of the Act.

The above is not an all inclusive list of the violations found during your inspection. You should take prompt action to correct these violations, and you should established procedures whereby such violations do not recur. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice to you Regulatory action may include injunction and/or prosecution.

Please notify this office within 15 working days of receipt of this letter, of the steps you have taken to correct the noted violations and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating correction.

You should direct your response to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, to the attention of Elizabeth A. Laudig, Compliance Officer. If you have questions regarding this letter, you may contact Elizabeth A. Laudig at 410-779-5441.

Sincerely,

/S/

Lee Bowers
Director, Baltimore District

Dr. Mohamed Ibraheim, District Manager
USDA/FSIS
5601 Sunnyside Ave.
Suite 1-2288 B
Beltsville, MD20705-5200

Ms. Susan Skelton
Virginia Department of Agriculture and Consumer Safety
Meat and Poultry Division
1100 Bank Street
Richmond, VA 23219