Public Health Service Food and Drug Administration
Dallas District Office 4040 North Central Expressway Suite 300 Dallas, Texas 75204-3128
March 21, 2016
Derreck M. Maxey, Owner
877 County Road 118
Riesel, Texas 76682-2954
Dear Mr. Maxey:
On December 7-14, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dealer operation located at 378 County Road, 152, Riesel, Texas 76682. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection 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 September 11, 2015, you sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On September 11, 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 0.97 parts per million (ppm) of desfuroylceftiofur which is a marker residue of ceftiofur in the kidney and 26.02 ppm of oxytetracycline in the kidney. FDA has established a tolerance of 0.4 ppm for residues in the kidney tissue of cattle for Desfuroylceftiofur, as codified in Title 21, Code of Federal Regulations Part 556.113 (21 C.F.R. 556.113). FDA has established a tolerance of 12 ppm for the sum of residues of the tetracyclines including oxytetracycline for residues in the kidney tissue of cattle, as codified in 21 C.F.R. 556.500. The presence of these drugs in edible tissues from this animal in these amounts 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records; you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals; and you failed to maintain records regarding the identity of and to record the existing identification of the animal(s) that you purchased and transported and delivered for sale. 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).
Our investigations also revealed that on September 11, 2015, you provided (b)(4), a signed certification stating that the livestock you sell does not have illegal levels of drug residues. On September 11, 2015, you delivered the cow identified with ear tag (b)(4) and back tag (b)(4), which contained violative residues of desfuroylceftiofur and oxytetracycline, to (b)(4) for slaughter. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 Paul E. Frazier, 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 Mr. Frazier at 214-253-5340.