| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
April 19, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 20
Rolland E. Durst
Dairy Manager/Partner
Durst Brothers, Inc.
56541 245th Avenue
Mantorville, Minnesota 55955-6068
Dear Mr. Durst:
On December 6 - 7, 2010, the Minnesota Department of Agriculture conducted an investigation of your dairy operation located at 56541 245th Avenue, Mantorville, Minnesota 55955-6068. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were found during the investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
The investigation found that you adulterated the new animal drugs penicillin G procaine (b)(4) and tilmicosin injection (b)(4). Specifically, the investigation revealed that you did not use penicillin G procaine and tilmicosin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (21 CFR), section 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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.
The investigation found that you administered penicillin G procaine injectable suspension (b)(4) to one of your dairy cows identified with ear tag# (b)(4) without following the dose as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a). 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 Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. § 351(a)(5).
The investigation also found that you administered tilmicosin injection (b)(4) to a dairy cow identified with ear tag #(b)(4). Tilmicosin is not approved to be used in female dairy cattle 20 months of age or older in accordance with 21 CFR 522.2471. Your extralabel use of tilmicosin injection was not under the supervision of a licensed veterinarian in violation of 21 CFR 530.11 (a). 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 Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 Rebecca L. Caulfield, Compliance Officer, Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Ms. Caulfield at (612) 758-7194 or e-mail at rebecca.caulfield@fda.hhs.gov.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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