FDA WARNING_LETTER - Sudan Vet Services - November 03, 2014

On October 31 and November 3, 2014, the FDA investigated Sudan Veterinary Services, P.A., regarding drug prescribing practices. The investigation found that the practice caused new animal drugs, (b)(4) (sulfadimethoxine) and (b)(4) (penicillin G procaine), to be unsafe and adulterated under sections 512(a)(1) and 501(a)(5) of the FD&C Act, respectively, due to non-compliance with 21 C.F.R. Part 530, Extralabel Drug Use in Animals.

Specifically, the practice directed extralabel use of (b)(4) for metritis in a dairy cow at a higher dosage than labeled, failing to meet 21 C.F.R. 530.20(a)(2)(i), (ii), and (iv) requirements for careful diagnosis, establishing extended withdrawal periods, and ensuring no illegal drug residues. Additionally, (b)(4) was used extralabelly in a dairy cow without following approved dose, withdrawal time, and indications, which is prohibited by 21 C.F.R. 530.41(a)(9).

The FDA requires prompt corrective action and procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure or injunction. A written response detailing corrective steps and timelines is required