ROCKVILLE, Md.—The U.S. Food and Drug Administration (FDA) announced that the District Court for the District of New Mexico has enjoined Clovis, N.M-based Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce.
FDA cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008. During these inspections the FDA investigator noted that the defendants were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter; that they failed to review treatment records prior to offering an animal for slaughter; and they were using medications for unapproved indications not specified on the drug label.
FDA previously inspected Do-Rene Dairy on Feb. 1-5, 2005, and subsequently sent the owners a Warning Letter summarizing the deviations, which were similar to those found in the 2008 inspection. The letter informed the owners that a failure to correct all violations may result in enforcement action, including seizure or injunction.
Tissue samples collected by FDA since 2003 found that the dairies offered 12 animals for slaughter with illegal drug residues. The animals included dairy cows that tested positive for illegal levels of the drugs flunixin, penicillin, neomycin and sulfadimethoxine, a drug expressly forbidden for use in lactating cows. In addition, four bob veal calves tested positive for sulfamethoxazole. These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.
Under the terms of the consent decree, the defendants and their employees cannot introduce any adulterated food into commerce, use animal drugs in an "extralabel" manner without a valid veterinarian-client-patient relationship or use drugs in animals in which such drugs are expressly forbidden. Failure to obey the terms of the consent decree could result in civil or criminal penalties.