- Animal & Veterinary
- Hart of Texas Cattle Feeders, LLC
- Issuing Office:
- Dallas District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
July 3, 2014
William D. Burnett, General Manager
Hart of Texas Cattle Feeders, LLC
2635 CR 521
Hart, Texas 79043
Dear Mr. Burnett:
On April 8 through April 10, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your feed yard operations located at 2635 CR 521, Hart, Texas 79043. 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 November 6, 2013, you sold a total of seven culled cattle, identified with ear tags (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4), for slaughter as food. On or about November 7, 2013, (b)(4), (b)(4), slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from one of these animals identified the presence of desfuroylceftiofur, marker residue for ceftiofur, at 11.55 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113. The presence of this drug in edible tissues 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, you failed to maintain complete treatment records. Specifically, our investigation found your treatment records did not contain accurate withdrawal times. 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 also found that you adulterated the new animal drug (b)(4) Sterile Suspension ((b)(4), NADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by the approved labeling or by the servicing veterinarian’s prescription. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) Sterile Suspension ((b)(4), NADA (b)(4)) to one of your culled animals without following the withdrawal periods as stated on the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 C.F.R. Part 530, you caused this drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
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.
We have reviewed your written response dated April 21, 2014 and have determined it is inadequate. Specifically, although you state you have corrected the withdrawal times for (b)(4) and (b)(4), you did not identify if a full review of the programmed withdrawal times for all your drugs are correct. In addition, although the response states you will print and maintain the treatment records for each animal, you did not identify how your firm will review the treatment records prior to the shipment to ensure they are accurate and the animal has met the appropriate withdrawal times. Further, we acknowledge you have committed to adding route of administration and name of the individual treating the animal to your medication records. Please provide an example of your current treatment record for our review.
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 Jeffrey 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 or email at Jeffrey.Wooley@fda.hhs.gov.
Reynaldo R. Rodriguez Jr.,
Close Out Letter