FDA WARNING_LETTER - B & E Dairy - November 19, 2013

On November 4 and 19, 2013, the FDA inspected B & E Dairy, identifying violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on August 5, 2013, had desfuroylceftiofur (ceftiofur marker residue) at 1.8 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain complete treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drugs (b)(4) and (b)(4) were adulterated. (b)(4) was administered without following the approved labeling or veterinary prescription duration, and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a). (b)(4) was administered without following the approved labeling or veterinary prescription frequency, and is prohibited for extralabel use in cattle by 21 C.F.R. 5