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U.S. Department of Health and Human Services

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Enforcement Actions

Buffalo Equine & Large Animal Clinic, LLP 31-Oct-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone : (612) 758-7133
FAX: (612) 334-4142


 

October 31, 2005

WARNING LETTER

CERTIFIED MAIL
REUTRN RECEIPT REQUESTED

Refer to MIN 06-11

David J. Wright, DVM
Partner
Buffalo Equine & Large Animal Clinic, LLP
1215 Highway 25 N., Suite 2
Buffalo, Minnesota 55313

Dear Dr. Wright:

On July 8, 2005, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs iii your veterinary practice. That investigation revealed that you caused an animal drug to be unsafe under section 512(a) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act j21 U.S.C. 351(a)(5)] because the drug was used in a manner that did not conform with its approved uses or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (21 CFR), Part 530.

Our investigation found that you administered [redacted] brand of sulfadimethoxine injection - 40% to treat peritonitis and mastitis in lactating dairy cattle, which is not an approved use of this drug. The extralabel use of an approved animal or human drug in animals is permitted only if it complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a) (4), (5)] and 21 CFR 530.21 CFR § 530.41(a)(9) prohibits the extralabel use of sulfadimethoxine in lactating dairy cattle, except approved uses. Your use was not one of the approved uses of Sulfadimethoxine injection, which are listed in 21 CFR § 522.2220. We enclose a copy of 21 CFR § 522.2220 for your reference.

You caused the aforementioned animal 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)] because the drug was used in a manner that did not conform with its approved uses or the regulations for Extralabel Drug Use in Animals, 21 CFR 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 Act, including the extralabel use regulations promulgated under the 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 CFR 530 for your reference. We strongly suggest that you review 21 CFR 530 and become familiar with all of its requirements so that you can prevent future violations of the Act.

You should notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Also include copies of any available documentation demonstrating that your corrections have been made.

Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.

Sincerely,

/s/
Cheryl A. Bigham for W. Charles Becoat
Minneapolis District