Federal authorities have taken legal action against Teva Animal Health Inc. to bar the company from making or distributing adulterated veterinary drug, the U.S. Food and Drug Administration (FDA) announced.
The action comes after FDA inspections of the company's St. Joseph, Missouri, facilities -- between 2007 and 2009 -- uncovered what officials call "significant" Good Manufacturing Practice (cGMP) violations.
"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.
Under the terms of a consent decree reached Friday, Teva Animal Health cannot resume making and distributing veterinary drugs until it complies with current cGMP standards and obtains approval from the FDA. An independent expert will inspect the companys facilities and procedures and certifies they comply with those standards.
If Teva Animal Health fails in the future to comply with any provision of the consent decree, cGMP, or the Federal Food, Drug, and Cosmetic Act, the FDA can order the company to stop making 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."
Under the consent degree, Teva Animal Health also faces penalties of $20,000 for each day the company fails to comply -- in the future -- with any provision of the decree and an additional $25,000 payment for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.