The FDA has filed for a consent decree of permanent injunction that prohibits Teva Animal Health Inc., from manufacturing and distributing adulterated veterinary drugs. The injunction will prevent the defendants from manufacturing and distributing veterinary drugs until they meet the current Good Manufacturing Practice (cGMP) standards and receive FDA approval.

“Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

From 2007 and 2009, FDA inspections revealed significant cGMP violations at Teva Animal Health's facilities in St. Joseph, Mo.

Under the terms of the consent decree, Teva Animal Health will not be able to begin manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established. In addition, an independent expert must inspect the facilities and procedures and certify that they comply with cGMP. Finally, the FDA will inspect Teva Animal Health's facilities as needed before authorizing the company to resume operations.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

If Teva Animal Health further violates the consent decree, they are subject to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174880.htm

Labels: drugs, FDA, good manufacturing, MO, St. Joseph, Teva Animal Health, veterinary