FDA WARNING_LETTER - Hart Dairy II - June 17, 2008

On June 13-17, 2008, the FDA investigated Hart Dairy II, owned by Laurens and Ilona Schilderink, at their Friona, Texas, dairy operation. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on March 27, 2008, a dairy cow sold for slaughter was found to have sulfadimethoxine residues in muscle (0.41 ppm) and liver (0.11 ppm), exceeding the FDA tolerance of 0.1 ppm. This rendered the animal's tissues adulterated under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the operation failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4).

The new animal drug sulfadimethoxine was also found to be adulterated under section 501(a)(5) because it was used extralabelly without complying with 21 C.F.R. Part 530. The drug was administered to a dairy cow without following the approved labeling for route of administration, withdrawal period, and indication for use. This extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited by 21 C.F.R. 530.