FDA WARNING_LETTER - Skogen, John L. - February 18, 2010

On February 2, 10, and 18, 2010, the FDA investigated John L. Skogen's dairy operation in Elmwood, Wisconsin, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on September 8, 2009, was found to have gentamicin in kidney tissue by USDA/FSIS analysis. Since FDA has not established a tolerance for gentamicin in cattle edible tissues, this rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment and drug inventory records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the Act.

Furthermore, Skogen adulterated new animal drugs by using them extralabelly without veterinary supervision, violating 21 CFR 530.11(a) and 21 CFR 530.41(a)(9). Specific instances included: * Gentamicin sulfate solution administered to replacement heifers without following approved labeling or veterinary supervision, resulting in illegal residues. * Sulfadimethoxine injection administered to lactating dairy cattle, which is prohibited for extralabel use. * Flunixin meglumine administered to lactating cows without following