FDA WARNING_LETTER - Dale Schmitmeyer Farm - December 07, 2012

On December 3-7, 2012, the FDA inspected a dairy operation at 5193 Siegrist-Jutte Road, Coldwater, Ohio, and found violations of the Federal Food, Drug, and Cosmetic Act. A Holstein dairy cow sold for slaughter on October 9, 2012, was found to have flunixin at 0.173 ppm in liver tissue (tolerance 0.125 ppm) and gentamicin in the kidney (no established tolerance). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, as it contained unsafe new animal drugs.

The investigation also revealed insanitary conditions, including failure to maintain treatment records, segregate treated animals, and properly store and dispose of drug products. These conditions make it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, on June 21, 2011, a false guaranty was provided, stating that livestock sold did not have illegal drug residues, which is prohibited by section 301(h) of the FD&C Act. The firm must take prompt action to correct these violations and prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to Allison C. Hunter,