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
January 29, 2014
WARNING LETTER NO. 2014-NOL-10
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Robert L. Campbell, Owner
Campbell Dairy Farm
2334 Clear Springs Road
Limestone, Tennessee 37681-5136
Dear Mr. Campbell:
On December 3 and 4, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, located at 1015 Splatter Creek Road, Limestone, Tennessee. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) we found during our investigation of your operation. You can find the Act and its associated regulations through links on FDA’s Internet home page at www.fda.gov.
We found you adulterated the new animal drug Prevail (flunixin meglumine, ANADA 200-308). Specifically, our investigation revealed you did not use Prevail as directed by its approved labeling. Use of this drug in this manner is an extra-label use [See Title 21, Code of Federal Regulations (CFR), Section 530.3(a); (21 CFR 530.3(a)].
The extra-label use of approved animal or human drugs in animals is allowed under the Act only if the extra-label use complies with Sections 512(a)(4) and (5) of the Act [21 United States Code (USC) 360b(a)(4) and (5)] and 21 CFR 530,which includes 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 Prevail to your dairy cows without following the route of administration, as stated in the approved labeling. Your extra-label use of Prevail was not under the supervision of a licensed veterinarian, which is in violation of 21 CFR 530.11(a). Because your use of this drug was not in conformance with the approved label directions and did not comply with 21 CFR 530, 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 producer of animals offered for use as food, you are responsible for ensuring 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 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 the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, to the address above. If you have any questions regarding this letter, please contact Compliance Officer Asente via (504) 832-1290 extension 1104.