Inspections, Compliance, Enforcement, and Criminal Investigations
Brunner Farm 7/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
July 12, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 38
Clyde J. Brunner
4757 Algoma Road
New Franken, Wisconsin 54229
Dear Mr. Brunner:
On April 3 and 10, 2012, the Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at 4757 Algoma Road, New Franken, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation. 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.
Our investigation documented that you sold prescription veterinary drugs, such as dinoprost tromethamine, dexamethasone, ceftiofur hydrochloride, and flunixin meglumine, without a written prescription or oral order from a licensed veterinarian. Under section 503(f)(1)(C) of the FD&C Act, the dispensing of a prescription drug other than by or upon the lawful written or oral order of a licensed veterinarian results in the drug being misbranded.
In addition, the prescription drugs that you sold/dispensed are misbranded within the meaning of section 502(f)(1) of the FD&C Act because they lack adequate directions for use. Pursuant to Title 21, Code of Federal Regulations, section 201.5, “adequate directions for use” means adequate directions under which the layman can use a drug safely and for the purposes for which it was intended. Such adequate directions for use by laypersons cannot be written for prescription drugs because the drugs can only be used safely at the direction of, and under the supervision of, a licensed veterinarian.
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.
Our investigation also revealed that you are not keeping complete drug treatment records and that you lack an adequate drug inventory system. Our investigator provided examples of drug treatment and inventory forms to you. In your affidavit dated April 10, 2012, you stated that you would review the forms and try to implement them.
You should notify this office in writing of the steps you have taken to bring your operation 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
Michael Dutcher, D.V.M.
Robert Ehlenfeldt, D.V.M.
Wisconsin Department of Agriculture
Division of Animal Health
P.O. Box 8911
Madison, Wisconsin 53708-8911