During FDA inspections in January 2002, January 2006, September 2010, and October through November 2012, investigators determined that the defendants had violated several provisions of the Federal Food, Drug, and Cosmetic Act.

These violations included failure to keep adequate medication records to prevent unsafe drug residues in cattle offered for slaughter, failure to review treatment records prior to offering an animal for slaughter, and the use of medications for unapproved uses not specified on the drug label and in a manner that does not comply with FDA regulatory requirements.
The defendants offered for slaughter seven dairy cows with illegal levels of drug residues. These included cows with tissues that tested positive for elevated levels of penicillin and sulfadimethoxine.

Ingesting food containing excessive amounts of antibiotics and other drugs can cause severe adverse reactions among the general population even at very low levels and can harm consumers who are sensitive to antibiotics. To date, no illnesses have been reported.
 “The illegal use of drugs in food-producing animals may adversely impact public health, and the FDA will take enforcement action against companies such as this one that violate the Act and our animal drugs regulations,” says Melinda K. Plaisier, the FDA’s associate commissioner for Regulatory Affairs.
The decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record-keeping systems to identify and track animals that have been treated with drugs. These records must also note the drug used, dosage, time of administration and how long before slaughter the drug needs to be discontinued.


If the defendants offer any animals for sale or slaughter, they also must provide written information about the animals’ drug treatment status to the recipient of the animals.
The FDA may order the defendants to cease operations if they fail to comply with any provisions of the consent decree, the Act, or FDA regulations. Failure to obey the terms of the consent decree could result in civil or criminal penalties.  end mark
—From FDA news release