Rupert Veterinary Clinic – FDA Warning Letter, May 29, 2015

On May 29, 2015, the FDA inspected Rupert Veterinary Clinic, LLC, finding violations related to extralabel drug use. Dr. Robert Ceglowski, DVM, caused the new animal drug sulfadimethoxine (ANADA (b)(4)) to be unsafe and adulterated under sections 512(a)(1) and 501(a)(5) of the FD&C Act, respectively, by failing to comply with 21 CFR Part 530, Extralabel Drug Use in Animals.

Specifically, Dr. Ceglowski prescribed sulfadimethoxine to calves for pneumonia at (b)(4) without ensuring the drug's extralabel use would not result in violative drug residues. This violated 21 CFR 530.20(a)(2)(iv), as a bob veal calf from (b)(4) was later found to contain illegal residues after slaughter.

Furthermore, adding sulfadimethoxine to wasted milk for calves caused the animal feed to be unsafe and adulterated under sections 512(a)(2) and 501(a)(6) of the FD&C Act, respectively. This constituted extralabel use of a medicated feed, which is prohibited by 21 CFR 530.11(b).

The FDA deemed the clinic's June 14, 2015, response inadequate,