Hite's Livestock, Inc. – FDA Warning Letter, Dec 3, 2010

On November 29 and December 3, 2010, the FDA investigated Hite's Livestock, Inc. and found violations of the Federal Food, Drug, and Cosmetic Act. An unidentified goat sold for slaughter around August 22, 2010, was found to have moxidectin residues (0.0383 ppm in liver, 0.0543 ppm in muscle) by USDA/FSIS analysis. FDA has not established a tolerance for moxidectin in goat tissues, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically a lack of a system to ensure animals sold for slaughter are free of harmful drug residues or are withheld for appropriate withdrawal periods. Additionally, the firm failed to keep accurate records for animal traceability, leading to adulteration under section 402(a)(4) of the FD&C Act.

To correct these violations and prevent recurrence, Hite's Livestock, Inc. must implement systems for animal identification and traceability, determine medication history from animal sources, and establish a system to withhold medicated animals from slaughter or clearly identify them as medicated. The firm must respond in writing within fifteen working days, detailing corrective actions taken or planned, with documentation. Failure to comply may result in regulatory actions like seizure or injunction.