FDA WARNING_LETTER - Chippewa Valley Veterinary Clinic, Ltd. - May 18, 2011

On April 11, 2011, and May 12 and 18, 2011, investigations by the Minnesota Department of Agriculture and FDA revealed that Chippewa Valley Veterinary Clinic, Ltd. caused the animal drug sulfadimethoxine to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively. The clinic failed to comply with 21 C.F.R. Part 530 regarding extralabel drug use in animals.

Specifically, the clinic administered an oral sulfadimethoxine concentrated solution intravenously to a lactating dairy cow, an extralabel use. Additionally, sulfadimethoxine 15 gram tablets were used for a 695-pound dairy cow with directions "3 a day 4 days," exceeding the indicated dosage of 1 ¼ tablets for the first day and ¾ of a tablet for subsequent days. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle per 21 C.F.R. 530.41(a)(9). Furthermore, the clinic did not comply with 21 C.F.R. 530.20(a)(2), which requires careful diagnosis, evaluation, and measures to ensure withdrawal times are met and no illegal drug residues occur. Culled dairy cows treated by the clinic were subsequently found to contain