FDA WARNING_LETTER - Nickels, Joseph E., Farm - August 29, 2013

On August 26 and 29, 2013, the FDA investigated Joseph E. Nickels' dairy operation in Argyle, Wisconsin, finding multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A dairy cow sold for slaughter on March 25, 2013, was found to be adulterated. USDA/FSIS analysis of liver tissue from this animal revealed 0.337 ppm of flunixin, exceeding the FDA tolerance of 0.125 ppm (21 CFR 556.286(b)(1)(i)), rendering 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 treatment records and a lack of a reliable system to identify medicated animals for slaughter, leading to the likelihood of harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug (b)(4) (penicillin G procaine) was adulterated. The dairy cow was administered (b)(4) extralabelly, not following approved labeling dosage and without the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). This extralabel use caused the drug to