FDA WARNING_LETTER - Double Aught Dairy, LLC - January 12, 2012

On January 10-12, 2012, the FDA inspected Double Aught Dairy, LLC, in Dexter, NM, and found violations of the Federal Food, Drug, and Cosmetic Act. A Holstein dairy cow sold for slaughter on September 6, 2011, by Double Aught Dairy, LLC, was found to have 0.17 ppm Penicillin in kidney tissue, exceeding the 0.05 ppm tolerance (21 CFR 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, specifically the failure to maintain an adequate system for withholding medicated animals from slaughter for appropriate drug depletion periods and the failure to maintain and review complete treatment records for medicated animals sold for food. These conditions cause food to be adulterated under section 402(a)(4) of the Act.

The FDA previously issued a Warning Letter on October 19, 2007, to Dan Dee Dairy, LLC, also owned by Mr. Flores, for illegal Flunixin residues in a dairy cow, citing sections 402(a)(2)(C)(ii), 402(a)(4), and 501(a)(5) of the Act. Double Aught Dairy, LLC, must take prompt action at all dairies