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  5. Kirk Farris - 481909 - 09/28/2015
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WARNING LETTER

Kirk Farris MARCS-CMS 481909 —

Product:
Animal & Veterinary

Recipient:
Kirk Farris


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 

 

September 28, 2015
 
2015-DAL-WL-33
WARNING LETTER
 
UPS OVERNIGHT
 
Billy Kirk Farris, Owner
Kirk and Sandy Farris
2549 Highway 86
Nazareth, Texas 79063-4045
 
Dear Mr. Farris:
 
From August 20 - 25, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at Country Road 520, Dimmitt, Texas 79027. 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 an animal for slaughter as food that was 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 February 6, 2015, you sold a bull, identified with ear tag (b)(4), for slaughter as food. On or about February 6, 2015, (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 ciprofloxacin and 0.084 part per million (ppm) of penicillin in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). FDA has not established a tolerance for residues of ciprofloxacin, a metabolite of enrofloxacin administration, in the kidney of cattle.
 
The presence of these drugs in edible tissue from 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 Jaw.
 
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 Thao Ta, 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 Thao Ta at 214-253-5217
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
cc:
USDA/FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, OM
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598
 
Texas Department of State Health Services
Attn: Lewis Ressler
Food Program Manager
Exchange Building
8407 Wall Street
Austin, Texas 78754