FDA WARNING_LETTER - Emerald Dairy, LLC and Emerald Dairy II, LLC - October 01, 2014

On December 8, 2014, the FDA issued a Warning Letter to Emerald Dairy II, LLC, following an investigation conducted on September 17, 19, and October 1, 2014. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on June 3, 2014, was found to be adulterated. USDA/FSIS analysis identified 0.653 ppm of penicillin in kidney tissue and 0.199 ppm of flunixin in liver tissue. These levels exceed the FDA tolerances of 0.05 ppm for penicillin (21 CFR 556.510(a)) and 0.125 ppm for flunixin (21 CFR 556.286(b)(1)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the FDA found that animals were held under insanitary conditions, failing to prevent medicated animals with potentially harmful drug residues from entering the food supply, which constitutes adulteration under section 402(a)(4) of the FD&C Act. Deficiencies included the lack of a system to control drug administration and incomplete treatment records, as noted on FDA Form 483 issued on October 1,