FDA WARNING_LETTER - Azevedo and Sons Dairy, Inc. - January 13, 2011

On January 5 and 13, 2011, the FDA investigated a dairy operation at 10034 Hendricks Road, Othello, Washington, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The operation offered for sale animals for slaughter as food that were adulterated. Specifically, a cow sold on July 23, 2010, contained 0.801 ppm flunixin in liver tissue, exceeding the 0.125 ppm tolerance (21 C.F.R. § 556.286). Another cow delivered on May 6, 2010, contained 0.755 ppm sulfadimethoxine in liver tissue, exceeding the 0.1 ppm tolerance (21 C.F.R. § 556.640). These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drugs Banamine (flunixin meglumine) and Albon (sulf