Inspections, Compliance, Enforcement, and Criminal Investigations
Lodi Veterinary Hospital, S.C. 1/30/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
January 30, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 06
Michael S. Etter, DVM, President
K.C. Brooks, DVM, Vice-President
Scott T. Pertzborn, DVM, Secretary-Treasurer
Lodi Veterinary Hospital
705 N. Main Street
Lodi, Wisconsin 53555
Dear Drs: Etter, Brooks and Pertzborn:
On September 5 and 10, 2008, an investigator from the U.S. Food and Drug Administration (FDA), conducted an investigation regarding the use of drugs in your veterinary practice located in Lodi, Wisconsin. Our investigation revealed that veterinarians from your firm caused the new animal drug sulfadimethoxine to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360b(a)(1), 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 with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 CFR 530). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
The extralabel use of approved veterinary or human drugs 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) and (5), and the implementing regulations at 21 CFR 530. Our investigation found that your firm failed to comply with these requirements. For example, your firm prescribed and sold sulfadimethoxine to be mixed with oxytetracycline for extralabel use in lactating dairy cows. Your firm used sulfadimethoxine oral 12.5% solution, which is not approved for use in lactating dairy cows, and labeled it for intravenous injection after mixing with oxytetracycline. Extralabel use of any sulfonamide drugs in lactating dairy cows is prohibited under 21 CFR 530.41(a)(9).
Because your firm's extralabel use of the new animal drug sulfadimethoxine was not in compliance with 21 CFR 530, your firm 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. You are responsible for complying with the requirements of the Act, and 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 this document and become familiar with all of, the requirements concerning extralabel use of new animal and human drugs so that you can prevent future violations of the Act.
You should notify this office in writing of the specific 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. We are particularly concerned that your clients may continue to use sulfadunethoxine oral solution and/or a compounded mixture of sulfadimethoxine oral solution/oxytetracycline to treat lactating dairy cattle. Please include information on how you intend to ensure such practice does not occur, and to educate your clients that such extralabel use would be illegal. Please include copies of any available documentation demonstrating that corrections have been made.
Your, written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat
Enclosure: 21 CFR 530