FDA WARNING_LETTER - Edwin Brasil Dairy - March 31, 2014

On June 12, 2014, the FDA issued a Warning Letter to Edwin Brasil Dairy following an investigation conducted on March 12, 17, 25, and 31, 2014. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A heifer sold for slaughter on October 31, 2013, was found to be adulterated. Tissue samples from this animal contained desfuroylceftiofur at 2.24 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113), and flunixin at 0.2 ppm in liver tissue, exceeding the 0.125 ppm tolerance (21 C.F.R. 556.286). 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 could lead to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the FD&C Act.

Furthermore, the dairy adulterated new animal drugs, including flunixin meglumine, penicillin G procaine, oxytetracycline hydrochloride, and tylosin,