Verona Veterinary Services, P. C. – FDA Warning Letter, Sep 25, 2013

On September 19, 20, and 25, 2013, the FDA inspected Verona Veterinary Services, P.C., regarding drug use. The investigation revealed that Dr. Steven C. Neth, DVM, caused the animal drug (b)(4) (ceftiofur crystalline free acid sterile suspension, (b)(4)) to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively. This was due to extralabel drug use not conforming to approved uses or 21 C.F.R. Part 530, Extralabel Drug Use in Animals.

Specifically, Dr. Neth administered (b)(4) to a dairy cow (farm tag # (b)(4)) for metritis without following the approved labeling's duration of treatment, which requires a second treatment within 72 hours. This extralabel use is prohibited by 21 C.F.R. 530.41(a)(13)(ii).

The FDA acknowledged a response dated October 24, 2013, but noted that this specific violation was not addressed during the inspection. Dr. Neth is responsible for complying with the FD&C Act and extralabel drug use regulations. Prompt corrective action and procedures to prevent recurrence are required. Failure to comply may result in regulatory action