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  5. L. D. McFarlin - 06/05/2015
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WARNING LETTER

L. D. McFarlin Jun 05, 2015

L. D. McFarlin - 06/05/2015

Product:
Animal & Veterinary

Recipient:
L. D. McFarlin


United States

Issuing Office:
Dallas District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204 

 

June 5, 2015
 
2015-DAL-WL-20
 
            WARNING LETTER
 
 
UPS OVERNIGHT
 
Leslie D. McFarlin, Owner
McFarlin Cattle
1136 County Road 319
Terrell, Texas 75161-6157
 
Dear Mr. McFarlin:
 
From February 2, 2015 through February 4, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef stocker cattle operation located at 1136 County Road 319, Terrell, Texas. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about August 9, 2014, you sold a steer, identified with back tag (b)(4), for slaughter as food. On or about August 11, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 4.27 parts per million (ppm) of florfenicol in the liver and 0.39 ppm of florfenicol in the muscle. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the liver of cattle and a tolerance of 0.3 ppm for residues of florfenicol in the muscle of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.283 (21 C.F.R. 556.283).
 
The presence of this drug in this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
 
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
 
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days of receiving this letter, 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 response should be sent to John W. Diehl, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204.  If you have any questions about this letter, please contact Compliance Officer John W. Diehl at 214-253-5288.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
  
cc: 
 
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598
 
Texas Department of State Health Services
Attn: E. Gregory Hutchins
1100 W. 49th Street
Austin, Texas 78756