FDA WARNING_LETTER - Pal-Nel Farms - October 17, 2007

On April 14, 2008, the FDA issued a Warning Letter to Pal-Nel Farms following an investigation on September 26 and October 17, 2007. The investigation confirmed the sale of adulterated animals for slaughter and unsafe use of the new animal drug neomycin sulfate.

Specifically, on April 18, 2007, Pal-Nel Farms consigned two bob veal calves for slaughter. USDA/FSIS analysis found neomycin in the kidney tissue of these animals at 272.43 ppm and 134.44 ppm, respectively. This significantly exceeds the 7.2 ppm tolerance for neomycin in cattle kidney tissue and is an illegal residue for veal calves, for which there is no acceptable level. This constitutes adulteration under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The investigation also revealed inadequate conditions, including a lack of an adequate system to ensure appropriate drug withdrawal times, leading to medicated animals with potentially harmful drug residues entering the food supply. Pal-Nel Farms failed to maintain treatment records for veal calves. Furthermore, the extralabel use of neomycin sulfate was not in conformance with approved labeling, specifically regarding the animal class and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.