Inspections, Compliance, Enforcement, and Criminal Investigations
Fullmer Cattle Company New Mexico LLC 09-Oct-07
Department of Health and Human Services
Public Health Service
Denver District Office
October 09, 2007
RETURN RECEIPT REQUESTED
Mr. Que Fullmer
Fullmer Cattle Company New Mexico LLC
2507 American Boulevard
Muleshoe, Texas 79347
Dear Mr. Fullmer:
An investigation of your cattle raising operation, located at 724 East Shuswap, Dexter, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 20 through June 26, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii)[21 U.S.C.342(a)(2)(C)(ii)] and 402(a)(4)[ 21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). 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 March 05, 2007, you sold two bob veal calves, identified with ear tags [redacted] to [redacted] for slaughter as food [redacted] This animal was slaughtered by [redacted]
United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue sample #450047, collected from bob veal calf with ear tag [redacted] identified the presence of 337.12 ppm Neomycin in the kidney, 1.28 ppm Neomycin in the muscle, 0.49 ppm Sulfadimethoxine in the liver, and 0.38 ppm Sulfadimethoxine in the muscle.
USDA/FSIS analysis of tissue sample #450048, collected from bob veal calf ear tag [redacted] identified the presence of 78.10 ppm Neomycin in the kidney, 0.48 ppm Sulfadimethoxine in the liver, and 0.60 ppm Sulfadimethoxine in the muscle.
A tolerance of 7.2 ppm has been established for residues of Neomycin in uncooked edible kidney tissue of cattle and 1.2 ppm in the uncooked edible muscle tissues of cattle as codified in Title 21 Code of Federal Regulations (CFR), section 556.430 (21 CFR 556.430). A tolerance of 0.1 ppm has been established for residues of Sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21 Code of Federal Regulations (CFR), section 556.460 (21 CFR 556.640). The presence of these drugs in the edible tissues of these animals 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 inadequate such 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 drug from edible tissues. For example, you failed to maintain treatment records and failed to segregate treated animals to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed prior to offering an animal for slaughter for human food. 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)].
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 assuring that your overall operation and the foods you distribute are 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, within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct these violations and preclude 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 with your response copies of any documentation demonstrating that corrections have been made. Your response should be sent to Nancy G. Schmidt, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303)236-3046 if you have any questions about this matter.
B . Belinda Collins
Ms. Lorey Briney
Fullmer Cattle Company - New Mexico
724 East Shuswap
Dexter, NM 88230
Mr. Robert K. Jones, D.V.M
Boulder District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, New Mexico 88003-8005