George Boere Dairy – FDA Warning Letter, Apr 10, 2013

On February 28, March 26, and April 10, 2013, the FDA inspected George Boere Dairy in Menifee, California, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on December 19, 2012, a cow sold for slaughter (ear tag # (b)(4)) had desfuroylceftiofur in its kidney at 4.6 ppm, 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 failed to maintain treatment records, indicating unsanitary conditions where medicated animals with harmful drug residues could enter the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Excenel RTU NADA 140-890 (ceftiofur) was adulterated. The dairy administered Excenel RTU to a cow (ear tag # (b)(4)) without following approved labeling or veterinary prescription regarding treatment duration. This extralabel use is prohibited in cattle by 21 C.F.R. 530.41(a)(13