FDA WARNING_LETTER - mathis ranch, llc - March 25, 2008

An FDA inspection of Mathis Ranch, LLC dba Texas Legend Ranch, conducted February-March 2008, revealed significant violations. The inspection was prompted by a USDA/FSIS report from July 2007, indicating violative drug residues in a goat originating from the ranch.

On May 28, 2007, the ranch sold a goat for slaughter that, when processed on June 6, 2007, showed moxidectin residues of 0.0577 ppm in the liver and 0.0161 ppm in muscle. No tolerance for moxidectin in goat tissues exists, rendering the food adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection found the ranch lacked an adequate system to ensure appropriate drug withdrawal times, leading to a likelihood of medicated animals with harmful residues entering the food supply. Specifically, incomplete treatment records were noted.

Furthermore, the new animal drug Cydectin (moxidectin) 0.5% Pour-On for Beef and Dairy Cattle (NADA 141-099) was adulterated under section 501(a)(5) of the Act due to extralabel use not conforming to approved labeling. The drug was administered to a species not specified on the label