Bee-Line Farm – FDA Warning Letter, Mar 28, 2014

On March 19-28, 2014, the FDA inspected Bee-Line Farms, a dairy operation. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to adulterated food.

Specifically, on July 1, 2013, Bee-Line Farms sold a bull calf for slaughter. Post-slaughter analysis on July 17, 2013, by USDA/FSIS found sulfamethazine residues of 41.80 ppm in the liver and 38.74 ppm in muscle tissue. The FDA's tolerance for sulfamethazine in uncooked edible cattle tissues is 0.1 ppm (21 C.F.R. 556.670). For bob veal calves (pre-ruminating calves), there is no acceptable residue level for sulfamethazine. This presence of sulfamethazine caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

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

Bee-Line Farms is required to take