James G. Nesbitt
- Jimmy Nesbitt
2180 Piney Grove Loop Road
Olivehill, TN 38475
- Issuing Office:
- Cincinnati District Office
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Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
July 3, 2018
WARNING LETTER 554744
UNITED PARCEL SERVICE
Delivery Signature Requested
James G. Nesbitt, Owner
2180 Piney Grove Loop Road
Olivehill, Tennessee 38475
Dear Mr. Nesbitt:
On March 13 and 22, 2018, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation, located at 2108 Piney Grove Loop Road, Olivehill, Tennessee, as a follow up to a sulfamethazine residue that was found in a slaughtered bull. 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 Act and its associated regulations through links on FDA’s Internet web page at www.fda.gov
We 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 failed to maintain treatment records and you failed to identify animals transported and delivered for sale. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 USC 342(a)(4).
We also found that you adulterated the new animal drug Sustain III® Bolus (sulfamethazine, NADA 120-615). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations Part 530.3(a) (21 C.F.R. § 530.3(a)).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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.
During our investigation, you admitted to administering Sustain III®, an over the counter (OTC) product, to a black bull without following the indications for use and the route of administration, as stated in the approved labeling. Under your supervision, this black bull was treated with Sustain III® for “being old and slow” by crushing and mixing three (3) boluses of Sustain III® to feed. Sustain III® is not approved for these conditions. Additionally, the label states in part “…care should be taken not to crush the bolus”. Using OTC products in an extralabel manner requires a lawfully written order from a veterinarian. Your extralabel use of Sustain III® was not under the supervision of a licensed veterinarian, in violation of 21 CFR § 530.11(a) as illegal extralabel use of a drug.
Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 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 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 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.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
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