Inspections, Compliance, Enforcement, and Criminal Investigations
Mathis Ranch, LLC dba Texas Legend Ranch 23-Jun-08
Department of Health and Human Services
Public Health Service
June 23, 2008
RETURN RECEIPT REQUESTED
Wayne R. Mathis. Managing Partner
Mathis Ranch, LLC dba Texas Legend Ranch
2803 Highway 473
Kendalia, Texas 78027-2016
Dear Mr, Mathis:
An inspection of your livestock operation located at 2803 Highway 743, Kendalia, Texas, conducted by a representative of the U.S. Food and Drug Administration (FDA) on February 25 and 29, and March 25, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 342(a)(2)(C)(ii) & 342(a)(4)]. The inspection also revealed that you caused the new animal drug Cydectin (moxidectin) 0.5% Pour-On for Beef and Dairy Cattle (NADA 141-099) to become unsafe within the meaning of section 512 of the Act [21 U.S.C. § 360b] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. Our inspection was based upon a violative level of residue in tissues collected from a goat identified as originating from your operation which was reported to us by the United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) on or about July 3, 2007 You can find the act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about May 28, 2007, you sold a goat, identified by back tag number [redacted] through [redacted] to [redacted] for slaughter as food. [redacted] purchased the animal on order for [redacted]. On or about June 6, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of moxidectin in the liver at 0.0577 parts per million (ppm) and in the muscle at 0.0161 ppm. No tolerance has been established for residue of moxidectin in the edible tissues of goats. The presence of this drug in edible tissues from this animal 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. 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 complete 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)]
In addition, you adulterated the new animal drug Cydectin (moxidectin) 0.5% Pour-on for Beef and Dairy Cattle (NADA 141-099) within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the extralabel use complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. §§ 360b(a)(4) & 350b(a)(5)], and 21 C.F.R. Part 530, including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Our investigation found that your extralabel use of Cydectin (moxidectin) 0.5 % Pour-On for Beef and Dairy Cattle (NADA 141-099) failed to comply with these requirements.
For example, you administered the drug Cydectin (moxidectin) 0.5% Pour-On for Beef and Dairy Cattle (NADA 141-099) without following the approved animal species set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the 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 above violations and to establish procedures whereby such 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, 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 Mr. Sean M. Cheney, Recall and Emergency Coordinator, 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 Mr. Cheney at 214-253-5222.
Reynaldo R. Rodriguez, Jr.
Dr. Howard "Butch" Johnson, DVM
Texas Department of State Health Services
Meat Safety Assurance Unit
1100 West 49th Street
Austin, Texas 78756
James A. Brownlee, M.P.H.
Department of Health and Senior Services
Consumer and Environmental Health Services
P.O. BOX 360
Trenton, New Jersey 08625-0360