Dallas District Office 4040 North Central Expressway Suite 300 Dallas, Texas 75204
December 08, 2016
UPS OVERNIGHT MAIL
R. Renee Davis, President
JCO Livestock, L.P.
770 ACR 2303
Montalba, Texas 75853
Dear Ms. Davis:
On May 17-19, 2016 the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle operation located at 770 ACR County Road 2303, Montalba, Texas. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 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 February 9, 2016, you sold a bull, identified with back tag (b)(4) for slaughter as food. On or about February 12, 2016 (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 Florfenicol in the liver (target tissue) at 8.16 parts per million (ppm) and Sulfamethazine at 5.31 ppm. FDA has established a tolerance of 3.7 ppm for residues of Florfenicol and 0.1 ppm for Sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Sections 556.283(b)(1)(i) (21 C.F.R. § 556.283(b)(1)(i)) and 556.670 (21 C.F.R. § 556.670). 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, 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).
We acknowledge we received your response to the FDA 483, Inspectional Observations, dated June 09, 2016 and we found this response to be inadequate. You did not supply any evidence of your corrective actions. You did not supply any of the following records or documents with your response: employee training records, new policies and procedures, treatment records, animal identification records, inventory records or procedures to exclude the use of expired drugs. Therefore, we found your response to the FDA 483, Inspectional Observations to be incomplete and inadequate.
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.