FDA WARNING_LETTER - Van Erk Dairy LLC - July 19, 2013

On July 18-19, 2013, the FDA investigated Van Erk Dairy LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated culled dairy cow for slaughter on March 18, 2013. USDA/FSIS analysis of tissue samples from this animal, slaughtered on March 20, 2013, revealed desfuroylceftiofur (a ceftiofur marker) at 1.2 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that the dairy held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Specifically, the firm failed to systematically review treatment records to ensure proper drug use and adherence to withdrawal times before slaughter, violating section 402(a)(4) of the FD&C Act.

Furthermore, the firm adulterated the new animal drug Naxcel 4 grams Sterile Powder (Ceftiofur Sodium Sterile Powder, NADA #140-338) through extralabel use. The drug was administered to a dairy cow without observing the approved withdrawal period. This