Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
August 30, 2017
Jared R. Hettinga, Owner
Bovina Dairy, LLC
1120 FM 3333
Farwell, Texas 79325
On May 16, 2017 through May 17, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1120 FM 3333, Farwell, Texas 79325. 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 January 26, 2017, you sold a culled dairy cow, identified with ear tag (b)(4) to (b)(4) for slaughter as food. On or about January 27, 2017, (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 Sulfamethazine in the liver at 0.123 ppm, the tolerance Sulfamethazine is 0.1 ppm for residues of Sulfamethazine in the edible tissues of beef cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. § 556.670).
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. For example your animal treatment record system, (b)(4), did not include the route of administration, dose, person that administered medication and withdraw dates for the first day of treatment. In addition, you did not include the route of administration or the person who administered the medication for subsequent days of treatment in your (b)(4) system. 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)].
Your response to the FDA 483, Inspectional Observations, is not adequate. You do not include an example process to maintain accurate records for future reference that includes all required information for medication records. Also, you did not include an example of your updated treatment protocols for sulfamethazine, penicillin G procaine, Ceftiofur and florfenicol.
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 S. Alexander Hamblin, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer S. Alexander Hamblin at email@example.com or 214-253-5240.