John Malcore Livestock LLC – FDA Warning Letter, Apr 9, 2012

On February 28, March 17, and April 9, 2012, the FDA investigated John Malcore Livestock, LLC's cattle operation in Luxemburg, Wisconsin. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on December 27, 2011, a steer sold for slaughter by John Malcore Livestock, LLC, was found to have flunixin at 1.03 ppm in its liver, exceeding the tolerance of 0.125 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also failed to maintain complete treatment records, leading to conditions where medicated animals with potentially harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the firm illegally obtained and used by-prescription-only animal drugs, including (b)(4) (flunixin meglumine) Injectable Solution, without a valid veterinarian/client/patient relationship or licensed veterinarian's supervision. The extralabel use of (b)(4) (flunixin meglumine) Injectable Solution on a steer, not following the approved route of administration, resulted in an illegal drug residue, violating 21 CFR 530.11(a) and (