FDA WARNING_LETTER - Silva Dairy, Jesse P. - February 25, 2015

On April 2, 2015, the FDA issued a Warning Letter to Jesse P. and Helen M. Silva of Silva Dairy following an investigation on February 10 and 25, 2015. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on October 16, 2014, was found to have 0.891 ppm of sulfadimethoxine in its liver, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.640), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also failed to maintain complete treatment records, indicating insanitary 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 drugs (b)(4) (sulfadimethoxine) and (b)(4) (penicillin G procaine) Injectable Suspension were adulterated under section 501(a)(5) of the FD&C Act due to extralabel use. (b)(4) (sulfadimethoxine) was administered to lactating dairy cows without following approved labeling for dosage, duration, and indications, and