FDA Takes Action Against Teva

FDA has announced a consent decree of permanent injunction filed, that prohibits Teva Animal Health, from manufacturing and distributing adulterated veterinary drugs.

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. FDA 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, FDA may order the company to stop manufacturing and distributing veterinary drugs, recall the products, or take other corrective actions.

Michael Chappell, acting associate commissioner for regulatory affairs at FDA, said: “The FDA will not tolerate the manufacture and distribution of adulterated animal drugs. 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.