FDA WARNING_LETTER - Jerland Farm - January 25, 2013

On January 17 and 25, 2013, the FDA inspected Jerland Farms, a dairy operation in Barron, Wisconsin. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on October 3, 2012, Jerland Farms sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 3, 2013, showed 1.1 ppm of desfuroylceftiofur residue in the kidney and 0.303 ppm of flunixin in the liver. These levels exceed the FDA tolerances of 0.4 ppm for desfuroylceftiofur in kidney and 0.125 ppm for flunixin in liver, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Jerland Farms held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. An example cited was the failure to maintain complete treatment records.

Furthermore, Jerland Farms adulterated new animal drugs, specifically (b)(4) (ceftiofur sodium) Sterile Powder and (b)(4) (fl