Double M Jerseys – FDA Warning Letter, May 24, 2011
On May 11 and 24, 2011, the FDA investigated Double M Jerseys' dairy operation in Tipton, California, identifying violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
A cow consigned for slaughter on February 17, 2011, was found to have flunixin at 0.569 ppm in liver tissue, exceeding the tolerance of 0.125 ppm (21 C.F.R. 556.286). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.
The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.
Furthermore, Double M Jerseys adulterated the new animal drug (b)(4) (flunixin meglumine) Injectable Solution by using it extralabelly without following the approved route of administration and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use also resulted in an illegal drug residue, violating 21 C.F.R. 530.11(
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