CMS # 407505
VIA UPS Next Day Air
November 8, 2013
Kent Henderson, D.V.M., President and Partner
Peter A. Averill, D.V.M., Vice-President and Partner
Stephen T. Wadsworth, D.V.M., Vice-President and Partner
Jennifer Hull, D.V.M., Secretary and Partner
Allison F. Maslack, D.V.M., Treasurer and Partner
Blake T. Nguyen, D.V.M.
Northwest Veterinary Associates, Inc.
6 Fairfield Hill Road
Saint Albans, Vermont 05478
Dear Dr. Henderson:
On May 22 to June 19, 2013, 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 that you caused animal drugs to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (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 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 veterinary or human drugs in animals is permitted only if it complies with sections 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. Our investigation found that your firm failed to comply with 21 C.F.R. Part 530, in that your firm prescribed the human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP (b)(4) to be administered to calves after dissolving it in milk replacer for the treatment of scours at (b)(4), between September 2011, and our current investigation of June 2013. This is an extralabel use. Your firm’s prescription for the extralabel use of this drug did not meet the requirements of 21 C.F.R. 530.20(a)(2)(i)-(iv) which require that you:
(i) Make a careful diagnosis and evaluation of the conditions for which the drug is to be used;
(ii) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable;
(iii) Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
(iv) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment.
Your firm caused the aforementioned animal drug 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 prescribed and used in a manner that did not conform with their approved uses or the regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530.
The above is not intended to be an all-inclusive list of violations. As licensed veterinarians, 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.
FDA acknowledges the written response we received following our inspection. A letter dated July 8, 2013, was received addressing the observations made during the inspection conducted on May 22 to June 19, 2013. Although your letter indicates that you will take steps to address our observations, we find that it is inadequate to specifically address all of the violations noted above.
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 Act.
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 the Food and Drug Administration, Attention: Scott M. Loughan, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 109.
Amber G. Wardwell
Acting District Director
New England District