November 26, 2013
WARNING LETTER NYK-2014-12
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
Dr. Steven C. Neth, DVM
Verona Veterinary Services, P.C.
5633 State Route 31
Verona, New York 13478
Dear Dr. Neth:
On September 19, 20, and 25 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation regarding the use of drugs in your veterinary practice. That investigation revealed that you caused the animal drug (b)(4) (ceftiofur crystalline free acid sterile suspension, (b)(4), 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 its approved uses or 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 512(a)(5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and § 360b(a)(5), and 21 C.F.R. Part 530:
- You used (b)(4) in an extralabel manner by administering the drug to a dairy cow identified with farm tag #(b)(4), without following the duration of treatment as stated in the approved labeling. For the treatment of metritis, the approved labeling calls for a second treatment within 72 (seventy two) hours. The extralabel use of this drug in this animal is prohibited by 21 C.F.R. 530.41(a)(13)(ii).
You 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 drug was used in a manner that did not conform with its 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 veterinarian, you are responsible for complying with the requirements of the FD&C Act, including the extralabel drug 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.
FDA acknowledges the written response we received following our inspection. A letter dated October 24, 2013, was received addressing the observations made during the inspection conducted on September 19, 20, and 25 2013. Although your letter indicates that you will take steps to address our observations, this violation was not addressed during the inspection.
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 LCDR Frank Verni, RPh, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Verni at (718)662-5702 or frank.verni@fda.hhs.gov.
Sincerely yours,
/S/
Ronald Pace
District Director
New York District
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