FDA Takes Action Against Dairy Farm And Owner

Main Category: Water - Air Quality / Agriculture
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Nov 2009 - 4:00 PDT

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On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.

Under the terms of the Decree, the defendants cannot introduce any adulterated food into commerce or use drugs in animals in which such drugs are expressly forbidden. The Decree also prohibits the defendants from using animal drugs in an "extralabel" manner without a valid veterinarian-client-patient relationship. The defendants must provide purchasers and consignees with written statements about the animals' drug treatment status at the time of sale. The FDA may order the defendants to cease operations if they fail to comply with any provision of the Decree, the Federal Food, Drug, and Cosmetic Act, or its regulations. Failure to obey the terms of the Decree could result in civil or criminal penalties.

Old Carolina Farm has a history of selling dairy cows and bob veal calves for slaughter for human food that contain illegal residues of new animal drugs. The presence of drug residues above the established tolerance levels for human food poses a serious health hazard to the public.

The FDA has inspected Old Carolina Farm several times during the past decade. During the most recent inspections, in October 2007 and May 2009, defendants admitted that they had sold animals for slaughter for use as human food before drug withdrawal times had expired, resulting in illegal drug residues. Defendants admitted that they did not maintain any animal medical treatment or drug inventory records.

The FDA issued a warning letter to Old Carolina Farm in January 2008, but the defendants failed to come into compliance with the law.

To read the 2008 Warning Letter.

Source
U.S. Food and Drug Administration

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