Company fails to adhere to current Good Manufacturing Practice regulations
The U.S. Food and Drug Administration announced a consent decree of permanent injunction filed today, that prohibits Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the defendants from manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain 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.
During inspections between 2007 and 2009, the FDA found significant cGMP violations at Teva Animal Health’s facilities, located in St. Joseph, Mo.
Under the terms of the consent decree, Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with cGMP. The FDA also will also inspect Teva Animal Health’s facilities as needed before authorizing the company to resume operations. If, after resuming operations, the defendants fail to comply with any provision of the consent decree, cGMP, or the Federal Food, Drug, and Cosmetic Act, the FDA may order the company to stop manufacturing and distributing veterinary drugs, recall the products, or take other corrective actions.
“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.”
In the event of future violations, the consent decree also subjects Teva Animal Health 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.