Inspections, Compliance, Enforcement, and Criminal Investigations
Perry Veterinary Clinic 10/28/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
October 28, 2009
WARNING LETTER NYK-2010-04
VIA FEDERAL EXPRESS
Leslie Scott DeGroff, D.V.M.
Perry Veterinary Clinic
3180 Center Road
Perry, New York 14530
Dear Dr. DeGroff:
On June 30, July 2, 6, August 4 and 6, 2009, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That investigation revealed you caused the animal drug sulfadimethoxine to be unsafe within the meaning of section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 360b] 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 the approved uses or the regulations for Extra Label Drug Use in Animals, Title 21, Code of Federal Regulations (21 CFR), Part 530 (21 C.F.R. Part 530).
The extra label use of approved veterinary or human drugs in animals is permitted only if it complies with section 512(a)(4) and (5) of the Act [21 U.S.C. § 360b(a)(4) and (5)], and 21 CFR Part 530. Our investigation found you failed to comply with 21 C.F.R. Part 530 because you prescribed sulfadimethoxine to treat lactating dairy cattle for pneumonia (b)(4) at located in (b)(4) at a dosage greater than that provided on the drug label. This is an extra label use. 21 C.F.R. § 530.4I(a)(9) prohibits sulfadimethoxine from extra label use in lactating dairy cattle.In addition, even if sulfadimethoxine were not on the list of drugs prohibited from extra label 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 extra label treatment. (b)(4) offered two dairy cows for slaughter as food that were subsequently found to contain illegal residues in edible tissue.
This occurrence is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the Act, including the extra label 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 C.F.R. Part 530 for your reference. We strongly suggest you review 21 C.F.R. Part 530 and become familiar with all of its requirements so you can prevent future violations of the Act. In addition, we are enclosing a copy of 21 C.F.R. § 520.2220b, which lists approved uses of sulfadimethoxine boluses.
You should notify this office in writing within fifteen (15) working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, 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, 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 response should be sent to Dean Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl St, Suite 100, Buffalo, NY 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at 716-541-0324.
Laurence D. Daurio
Acting District Director
New York District
Enclosures: 21 C.F.R. § 520.2220b
21 C.F.R. Part 530