FDA WARNING_LETTER - Goyenetche Dairy, Albert - March 31, 2015

On April 27, 2015, the FDA issued a Warning Letter to Albert M. Goyenetche, owner of Goyenetche Dairy, following an investigation on March 24 and 31, 2015. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on December 15, 2014, was found to be adulterated. USDA/FSIS analysis revealed desfuroylceftiofur residues at 0.92 ppm in the kidney (tolerance 0.4 ppm) and flunixin residues at 0.502 ppm in the liver (tolerance 0.125 ppm) and 0.223 ppm in the muscle (tolerance 0.025 ppm). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also held animals under insanitary conditions, failing to maintain complete treatment records, which may lead to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4).

Furthermore, the new animal drugs (b)(4) (ceftiofur) and (b)(4) (flunixin meglumine) were adulterated under section 501(a)(5) due to extralabel use. The investigation found