The injunction, filed in U.S. District Court in Kansas City, prevents the defendants from manufacturing and distributing any veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain FDA approval.
Teva Animal Health, a unit of the Israeli pharmaceutical firm Teva Pharmaceutical Industries, sells medicines for dogs, cattle, horses, sheep, swine and cattle, including flea and tick shampoos, ear washes and antibiotics.
Teva "regrets the deficiencies in our manufacturing practices, and we already have initiated corrective actions to ensure that we will swiftly meet all regulatory requirements," says Teva spokeswoman Denise Bradley. The firm is now analyzing each product, retraining production employees and revalidating equipment, processes and methods of production, she said. The FDA closed the firm’s plant in St. Joseph, Mo., last Friday for failure to comply with cGMP and for other violations, based on inspections over the last two years.
The FDA’s consent decree says Teva failed to reject drugs that didn’t meet established FDA specifications, did not conduct adequate equipment maintenance, failed to train employees adequately and failed to establish a quality-control unit, among other violations.
During five regulatory meetings with the FDA between June 2007 and June 2009, company officials had “shown they are unwilling or unable to take the necessary steps to prevent recurrence” of cGMP violations, the FDA said.
“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,” says Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine.
The FDA will inspect Teva’s facilities as needed before authorizing it 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 firm to stop manufacturing and distributing veterinary drugs, recall the products or take other corrective actions, the FDA statement says.
"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," says Michael Chappell, FDA acting associate commissioner for regulatory affairs.
In the event of future violations, the consent decree subjects Teva Animal Health to payments of $20,000 per day for each day it fails to comply with any provision in the decree and an additional $25,000 for each shipment of veterinary drugs in violation, up to $7.5 million per year.