- Animal & Veterinary
- South Central Livestock, Corporation
- Issuing Office:
- New Orleans District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
||New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
February 26, 2015
WARNING LETTER NO. 2015-NOL-06
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Bert E. Smith, IV, Owner
South Central Livestock Corporation
2792 Gold Road
Lewisburg, Tennessee 37091-6117
Dear Mr. Smith:
On January 8, and 15, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation, located at 2792 Gold Road, Lewisburg, Tennessee. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations through links on FDA’s Internet 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 Act, [21 United States Code (USC) 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 Act, [21 USC 360b]. Further, under Section 402(a)(4) of the Act, [21 USC 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 October 11, 2014, you sold a cow, identified with back tag number (b)(4) and ear tag (b)(4) for slaughter as food. On or about October 15, 2014, (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 19.36 parts per million (ppm) of florfenicol in the liver tissue and 6.99 ppm in the muscle tissue. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the liver tissue and 0.3 ppm in the muscle tissue of cattle, as codified in Title 21, Code of Federal Regulations Part 556.283 (21 CFR 556.283). Additionally, USDA/FSIS analysis of the tissue sample collected from this animal identified the presence of 4.55 ppm of flunixin in the liver tissue and 0.27 ppm in the muscle tissue. FDA has established a tolerance of 125 parts per billion (ppb) (0.125 ppm) for residues of flunixin in the liver tissue and 25 ppb (0.025 ppm) in the muscle tissue of cattle, as codified in 21 CFR 556.286. 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 Act, [21 USC 342(a)(2)(C)(ii)].
Our investigation also found 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 USC 342(a)(4)].
We also found you adulterated new animal drugs florfenicol 300 mg/mL injectable antimicrobial (NuflorGold™, NADA # 141-265), and flunixin meglumine 50 mg/mL sterile injectable solution (Prevail™, ANADA# 200-387). Specifically, our investigation revealed you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with Sections 512(a)(4) and (5) of the Act, [21 USC 360b(a)(4) and (5)], and 21 CFR 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found you administered NuflorGold™ to a Black Angus beef cow with back tag number (b)(4) without following the route of administration, as stated in the approved labeling. Your extralabel use of NuflorGold™ was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Your extralabel use of NuflorGold™ resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
Our investigation also found you administered Prevail™ to a Black Angus beef cow with back tag number (b)(4) without following the route of administration as stated in the approved labeling. Your extralabel use of Prevail™ was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Your extralabel use of Prevail™ resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
Because your use of these drugs was not in conformance with their approved labeling, you caused the drugs to be unsafe under Section 512(a) of the Act, [21 USC 360b(a)], and adulterated within the meaning of Section 501(a)(5) of the Act, [21 USC 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 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 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 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 Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Mrs. Dutzek at (615) 366-7826.
Ruth P. Dixon
New Orleans District
Scott E. Seebohm, DVM, Deputy Director
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development
Policy Development Division
1616 Capitol Ave, Suite 260
Omaha, NE 68102
Jimmy Hopper, Director
Tennessee Department of Agriculture
440 Hogan Road
Nashville, TN 37204