Public Health Service
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
March 28, 2016
Via UPS Overnight Delivery
Refer to MIN 16 - 09
Shirley A. Baroun, Co-Owner
Mike Baroun, Co-Owner
Thomas Kostechka, Co-Owner
Kostechka Dairy, LLC
12031 West Hillcrest Road
Whitelaw, Wisconsin 54247-9741
Dear Mr. and Mrs. Baroun and Mr. Kostechka:
On December 3 and 29, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12031 West Hillcrest Road, Whitelaw, Wisconsin. 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 FD&C 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 adulterated the new animal drugs (b)(4) (ceftiofur hydrochloride, ANADA (b)(4)) and (b)(4) (Lincomycin-Spectinomycin, ANADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) and (b)(4) as directed by their approved labeling or prescription label. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulation, section 530.3(a), (21 CFR 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 U.S.C. § 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 found that you administered (b)(4) to your cows without following duration of treatment as stated in the approved labeling or prescription label. Certain uses of ceftiofur (e.g., unapproved duration or frequency of treatment) are prohibited for extralabel use in cattle by 21 CFR 530.41(a)(13)(ii).
Additionally, our investigation found that you administered (b)(4) to your lactating dairy cows without following the animal class as stated in the prescription label. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a).
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR 530, you caused these drugs 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 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 Dianna C. Sonnenburg, Compliance Officer, Food and Drug Administration, at the address in the letterhead. If you have any questions about this letter, please contact Ms. Sonnenburg at (612) 758-7125.