FDA WARNING_LETTER - Trout Brothers Dairy - June 04, 2010

On May 27 and June 4, 2010, the FDA inspected Trout Brothers Farm, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm sold adulterated animals for slaughter. Specifically, on September 16, 2009, two veal calves sold for slaughter contained neomycin residues in kidney tissues at (b)(4) ppm and (b)(4) ppm, exceeding the 7.2 ppm tolerance. On October 8, 2009, a dairy cow sold for slaughter had flunixin in liver tissue at (b)(4), exceeding the 0.125 ppm tolerance. These drug residues caused the food to be adulterated under section 402(a)(2) of the Act.

The investigation also found insanitary conditions, including failure to maintain treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). Furthermore, the farm engaged in extralabel use of flunixin by not following the approved withdrawal time and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and (d), and rendering the drug unsafe and adulterated under sections 512(a) and 501(a)(5).

Trout Brothers Farm must take prompt action to correct these violations and prevent