The U.S. Food and Drug Administration reported July 31 that it has taken action against Teva Animal Health Inc. because of the company’s failure to adhere to current Good Manufacturing Practice (cGMP) regulations.
The company said in a written statement: “Teva Animal Health regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements. These actions include conducting a complete analysis of each individual product, retraining of our employees, and revalidating our equipment, processes and methods.”
The decree of permanent injunction that was filed prohibits Teva Animal Health, 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 cGMP and obtain FDA approval, according to the statement released by the FDA.
The FDA reported that it found “significant cGMP violations” at the company’s facilities, located in St. Joseph, Mo., during inspections from 2007 to 2009.
The FDA said it will 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 said in a statement.
Teva Animal Health also may be subject to penalties in the event of future violations. For instance, it may be fined $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 a year.