On March 15 and March 30, 2017, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 4106 Ihm-Harris Road, Barneveld, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) revealed by our investigation of your operation. You can find the Act and its associated regulations on the internet through links on the FDA’s web page at www.fda.gov.
Our investigation 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. For example, you failed to maintain complete treatment records that include the dose, route of administration, estimated withholding time, diagnosis of the condition of the cow being treated, and person administering the drug. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
Our investigation also found that you adulterated the new animal drug (b)(4) (ceftiofur hydrochloride, NADA (b)(4)) when you treated your dairy cow identified with back tag (b)(4) (farm identification #(b)(4)).
Specifically, you administered (b)(4) to cow #(b)(4) in an extralabel manner. You did not follow the dosage per injection site, duration of treatment, and route of administration as stated in the approved labeling. You stated that you routinely administer the drug intramuscularly (IM), whereas the veterinary prescription states to administer the medication under the skin; your treatment records indicate that you administered (b)(4) for a duration of two days rather than three days per the veterinary prescription label; and you admit that you administer 25-27 ml (b)(4) IM per site whereas the approved labeling states not to inject more than 15 ml per injection site. Ceftiofur hydrochloride is prohibited for extralabel use in food producing animals by 21 CFR 530.41(a)(13)(ii).
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 complies 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 Boun M. Xiong, Compliance Officer, U.S. Food and Drug Administration at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVM
Director, Division 1 West
Office of Human and Animal Food Operations