FDA WARNING_LETTER - Johann Dairy - October 18, 2012

On October 9, 11, and 18, 2012, the FDA inspected Johann Dairy and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale animals for slaughter as food that were adulterated.

Specifically, a lactating dairy cow sold on March 30, 2012, contained penicillin at 0.08 ppm (tolerance 0.05 ppm) and sulfamethazine at 0.122 ppm in liver and 0.109 ppm in muscle. Sulfamethazine has no acceptable tolerance in lactating dairy cows. Two lactating dairy cows sold on May 29 and June 29, 2012, contained gentamicin, for which no tolerance exists in dairy cows. Two bob veal calves sold on May 2 and June 4, 2012, contained neomycin at 30.83 ppm and 56.14 ppm in kidney (tolerance 7.2 ppm), with no acceptable tolerance for veal calves. These residues caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The dairy also held animals under insanitary conditions, failing to maintain complete treatment records, which adulterated food under section 402(a)(4). Furthermore, the dairy adulterated new animal drugs (penicillin G