- Animal & Veterinary
- Lewisburg Livestock Market, Inc
- 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
March 3, 2015
WARNING LETTER NO. 2015-NOL-07
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Michael Schklar, Owner
Lewisburg Livestock Market, Inc.
6106 Underwood Drive
Springfield, Tennessee 37172
Dear Mr. Schklar:
On January 7 and 15, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your auction facility, located at 1930 Finley Beech 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 may find the Act and its associated regulations through links on FDA’s Internet home 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 on or about October 11, 2014, a culled Black Angus beef cow identified with back tag number (b)(4) and ear tag (b)(4) was consigned for sale at your auction and sold to (b)(4). The cow was transported to (b)(4), where it was slaughtered for food on or about October 15, 2014. 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. Additionally, you lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow them to be withheld from slaughter for an appropriate period of time to deplete potentially hazard residues of drugs from edible tissues. 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 the new animal drug flunixin meglumine 50 mg/mL sterile injectable solution (Prevail™, ANADA 200-387). Specifically, our investigation revealed you did not use this drug as directed by its approved labeling. Use of this drug 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 Part 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 also found you administered Prevail™ to your cattle 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). Because your use of this drug was not in conformance with its approved labeling, you caused the drug 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 distributor of animals offered for use as food, you are responsible for ensuring your overall operation and the food 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 injunction. To avoid future residue violations you should take precautions such as:
1. Implementing a system to determine whether animals you receive for auction have been medicated, with what drug(s), and the date the withdrawal period (if any) terminates.
2. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal, then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
3. Only use prescription drugs under the lawful written or oral order from a licensed veterinarian.
4. If you medicate animals, implement a system to maintain treatment records, which include the drug used, the withdrawal period, the amount administered, and the route of administration.
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.
FDA acknowledges the written response dated January 28, 2015, which we received following our inspection. In your response, you indicated you will now require notification of whether animals have been medicated on your check-in forms. However, you did not provide evidence this practice has been implemented. Additionally, you did not address your practice of administering prescription drugs to animals without the lawful written or oral order of a licensed veterinarian, or your failure to maintain treatment records for animals you gave medication, which are observation items two and three listed on the Form FDA 483, issued to you on January 15, 2015. Therefore, the effectiveness of your corrective measures can only be determined over time.
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.
Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention: Kimberly A. Dutzek, Compliance Officer, 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