Slate River Ranch LLC 9/17/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
September 17, 2013
Glade M. Knight, Managing Partner
Slate River Ranch, LLC.
814 E. Main Street
Richmond, VA 23219
Dear Mr. Knight:
On June 10-18, 2013 the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle ranch located at 1214 Price Chapel Rd, Perrin, Texas 76486. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we 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 December 17, 2012, you sold a heifer, identified with back tag (b)(4), for auction. On or about December 19, 2012, the heifer with back tag (b)(4) was slaughtered for food at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 6.46 parts per million (ppm) of florfenicol in the liver, 0.53 ppm of florfenicol in the muscle, and 6.90 ppm of sulfamethazine in the liver. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the liver tissues and 0.3 ppm for residues of florfenicol in the muscle of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.283 (21 C.F.R. 556.283). FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). The presence of these drugs in 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. For example, you failed to maintain complete treatment records prior to May 2013. 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).
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.
We acknowledge the June 28, 2013, response to the Form FDA 483, Inspectional Observations, sent by your Cattle Manager and have determined the corrective actions you have implemented are not adequate. Although your response states your firm has implemented a new record keeping system; you did not provide evidence to show the system has been implemented. Further, you did not show the appropriate personnel were trained on the new record keeping practices required by your facility.
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 Jeff R. Wooley, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions about this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251.
Reynaldo R. Rodriguez Jr.,
Dallas District Director
Texas Department of State Health Services
Food Program Manager
8407 Wall Street
Austin, TX 78754
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598