FDA WARNING_LETTER - Smith Dairy - July 26, 2013

On July 23-24 and 26, 2013, the FDA investigated Smith Dairy, operated by Craig D. Smith, in Flemingsburg, Kentucky. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on February 6, 2013, was found to have 0.64 ppm of desfuroylceftiofur (ceftiofur marker residue) in its kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113(b)(3)(i)). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the operation was found to hold animals under insanitary conditions, likely leading to drug residues in the food supply. Deficiencies included failure to maintain treatment records, identify and segregate treated animals, maintain an adequate drug inventory, and the presence of expired medications. These conditions caused food to be adulterated under section 402(a)(4) of the FD&C Act.

The drug Excede (ceftiofur crystalline free acid) was also adulterated. Smith administered Excede to a dairy cow without following approved labeling for indications and route of administration, constituting an extra-label use in violation of 21 C.F