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  5. Garnett Livestock - 07/13/2015
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WARNING LETTER

Garnett Livestock Jul 13, 2015

Garnett Livestock - 07/13/2015

Product:
Animal & Veterinary

Recipient:
Garnett Livestock


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 75204-3128 

 

July 13, 2015
 
2015-DAL-WL-23
 
WARNING LETTER
 
UPS Overnight
                                                                                                     
 
John B. Garnett, President
Garnett Livestock, Inc.
3258 FM 2943
Hereford, Texas 79045
 
 
Dear Mr. Garnett:
 
On March 17 – 18, 2015 the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 3258 FM 2943, Hereford, Texas 79045. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 December 7, 2014, you sold eight head of cattle, including the animal identified with ear tag (b)(4), for slaughter as food. On or about December 7, 2014, (b)(4) slaughtered the animal with ear tag (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.46 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 21 C.F.R 556.113. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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, your firm failed to inquire about the medication status of animals you purchase with intent to sell for slaughter for human food. Specifically, on or about December 3, 2014 you purchased (b)(4) animals, including the steer with ear tag (b)(4), from (b)(4). You did not inquire about the medication status of these animals.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
We received your written response dated March 18, 2015. Your response does not identify how often you will have your suppliers sign the agreement or how you will verify an agreement is in place prior to purchasing cattle from an individual supplier. You should evaluate how often suppliers will be required to sign your medication status statement and how you will confirm each supplier has a signed statement in place.
 
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 Jeff R. Wooley, 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 Jeff R. Wooley at 214-253-5251.
 
 
Sincerely,
/S/              
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
  
cc:      
Texas Department of State Health Services
Lewis Ressler
Food Program Manager
Exchange Building
8407 Wall Street
Austin, TX 78754
 
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598