| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7210 FAX: (612) 334-4142 |
Department of Health and Human Services
September 21, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11-57
Thomas J. Gianforte, DVM, Owner
Chippewa Valley Veterinary Clinic, Ltd.
N6294 State Road 25
Durand, Wisconsin 54736
Dear Dr. Gianforte:
On April 11, 2011, investigators from the Minnesota Department of Agriculture, acting on behalf of the Food and Drug Administration (FDA), conducted an investigation involving the use of drugs in your veterinary practice. On May 12 and 18, 2011, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. These investigations revealed that you caused the animal drug sulfadimethoxine to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (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), because the drug was used in a manner that did not conform with the approved uses or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (C.F.R.), Part 530 (21 C.F.R. Part 530).
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 section 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. 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 failed to comply with 21 C.F.R. Part 530 in that you prescribed the drug (b)(4) brand of oral sulfadimethoxine concentrated solution 12.5% in an extralabel manner by administering the drug intravenously to a lactating dairy cow from (b)(4) to treat metritis after surgery for a displaced abomasum. Additionally, you used the drug (b)(4) brand of sulfadimethoxine 15 gram tablets with directions “3 a day 4 days” for a dairy cow from (b)(4) that weighed 695 pounds.
The indicated dosage for a dairy cow weighing 695 pounds is 1 ¼ tablets for the first day and ¾ of a tablet for the following 3 to 4 days. In accordance with 21 C.F.R. 530.41(a)(9), sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle. In addition, even if sulfadimethoxine were not on the list of drugs prohibited from extralabel use in 21 C.F.R. 530.41, you did not comply with 21 C.F.R. 530.20(a)(2), which requires that you make a careful diagnosis and evaluation of the conditions for which the drug was to be used, and take appropriate measures to assure that the assigned timeframes for withdrawal are met and no illegal drug residues occur in any food producing animal subject to extralabel treatment. (b)(4) and (b)(4) offered those culled dairy cows for slaughter as food that were subsequently found to contain illegal residues in edible tissue.
You caused the aforementioned animal 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), because the drugs were used in a manner that did not conform with their approved uses or 21 C.F.R. Part 530.
The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian, you are responsible for complying with the requirements of the FD&C Act, including the extralabel use regulations promulgated under the FD&C Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
We have enclosed a copy of 21 C.F.R. Part 530 for your reference. We strongly suggest that you review 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the FD&C Act.
FDA acknowledges that during the FDA inspection conclusion on May 18, 2011, you pointed out the implementation of new policies to provide prescriptions with the proper information and the use of color code stickers indicating use for lactating animals and non-lactating animals. Although you indicated that you have taken steps to address our observations, your response did not contain enough detail for us to evaluate.
You should notify this office in writing of the steps you have taken to bring your firm 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 Demetria Lueneburg, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue Suite 600 Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Compliance Officer Lueneburg at 612/758-7210.
Sincerely,
/S/
Gerald Berg
District Director
Minneapolis District
xc: Robert Ehlenfeldt, DVM
State Veterinarian
WDA/Division of Animal Health
P.O. Box 8911
Madison, WI 53708-8911
Dennis Schuh
Administrator
Div. of Enforcement/State of Wisconsin
Department of Regulation & License
P.O. Box 8935
Madison, WI 53708-8935
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