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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

L & M Cattle Co. 09-Apr-07

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128


April 9. 2007

2007-DAL-WL-12

Certified Mail
Return Receipt Requested

WARNING LETTER

Leonard McDaniel, Owner
dba L & M Cattle Co.
Routs 3 Box 496
Idabel, Oklahoma 74745-9572

Dear Mr. McDaniel:

An investigation of your operation located in Idabel, Oklahoma, by a Food and Drug Administration investigator on December 19-20, 2006, confirmed you sold for slaughter three calves on or about November 5, 2006, to [redacted] who offered the calves for slaughter for human food at [redacted] that were adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act).

United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissues collected from these animals disclosed the presence of the drug gentamicin in the liver and kidney of two calves and in the kidney of the third calf. There is no tolerance established for residues of gentamicin in the edible tissues of bovine, Title 21, Code of Federal Regulation, Section 558.300. The presence of this drug in edible tissues from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii)[21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation found that you hold animals under conditions which are so inadequate that medicated animals bearing potentially harmful drug residues may enter the food supply. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act. You lack a system to ensure that animals you buy and sell have not been medicated or, if they have been medicated, that allows you or subsequent buyers to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.

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 assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated food. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as implementing a system to determine from the source of the animal whether the animal has been medicated, when the animal was medicated, and with what drug(s).

You should notify this office in writing within fifteen (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 fifteen (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 written reply should be directed to the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Sherrie L. Krolczyk, Compliance Officer.

Sincerely,

/S/

Michael A. Chappell
District Director
Dallas District

cc: Howard "Butch" Johnson, DVM
Texas Department of State Health Services
Environmental and Consumer Safety Section
Meat Safety Assurance Unit
1100 West 49th Street
Austin, Texas 78756

Julie Comett, DVM
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Famam Street
Omaha, Nebraska 68102