FDA WARNING_LETTER - De Saegher Cattle LLC - March 28, 2012

On March 20, 21, and 28, 2012, the FDA investigated De Saegher Cattle LLC's dairy operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on July 22, 2011, De Saegher Cattle LLC sold a cow for slaughter that was found to be adulterated. USDA/FSIS analysis of the cow's liver tissue identified sulfadimethoxine at 0.287 ppm, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.640). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. A specific deficiency noted was the failure to maintain complete treatment records. This is deemed adulteration under section 402(a)(4) of the FD&C Act.

The FDA acknowledged a written response from De Saegher Cattle LLC dated March 28, 2012, which stated that the sulfadimethoxine dosing was accidental, the drug was removed from the farm, and a new system for recording diagnoses, drug administration, dosages, routes, and controlling expired drugs