FDA WARNING_LETTER - Country Morning Farms - March 26, 2008

An FDA inspection of a dairy operation at 650 North Fox Road, Warden, Washington, from March 18-26, 2008, revealed violations related to the new animal drug sulfadimethoxine. The inspection found that the dairy caused sulfadimethoxine to become unsafe and adulterated under sections 512(a) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 1, 2008, a dairy cow consigned for slaughter had sulfadimethoxine in its liver tissue at 14.45 ppm. On February 19, 2008, another dairy cow had sulfadimethoxine in its liver tissue at 5.81 ppm. Both levels exceed the established tolerance of 0.1 ppm for sulfadimethoxine in cattle edible tissues (21 C.F.R. 556.640(b)).

The investigation determined that the dairy engaged in extralabel use of sulfadimethoxine without complying with regulatory requirements. Violations included administering a higher dosage than indicated on the approved label, failing to observe the pre-slaughter withdrawal period, and using sulfadimethoxine extralabelly in lactating dairy cows, which is prohibited (21 C.F.R. 530.41(g)). This extralabel use resulted in illegal drug residues