April 19, 2018

FDA Warns Malcore Livestock of Food Safety Violations

John Malcore Livestock, LLC of Luxemburg, Wisc. has committed a number of food safety violations, according to a June 27 warning letter from the U.S. Food and Drug Administration (FDA).

The FDA’s investigation of the livestock operation began after the discovery that, In late December, Malcore Livestock offered an adulterated animal for sale. “Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health,” the letter stated.

The animal cited was found to have drug residue in its tissue exceeding acceptable levels according to an analysis performed by the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).

As part of its investigation, the FDA visited Malcore Livestock three times: on February 28, March 17, and April 9, 2012. During these visits the FDA found other food safety violations including inadequate conditions for holding animals bearing potentially harmful drug residues, failure to maintain adequate treatment records, use of an animal drug in an unprescribed manner, illegal procurement of several prescription-only animal drugs and administering a drug without the supervision of a veterinarian.

Malcore Livestock was given 15 days to notify the FDA in writing of the steps it has taken to come into compliance with the law. Later this summer, FSIS will launch new testing methods for drug residue in meat, poultry and egg products designed to more efficiently and effectively enable USDA to identify illegal drug residues.

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