FDA Cracks Down on Teva Animal Health Inc.

Teva Pharmaceuticals is to be barred from selling veterinary drugs until it fixes manufacturing practices, the Food and Drug Administration said on Friday. The FDA found evidence that Missouri-headquartered Teva violated manufacturing standards during inspections from 2007 to 2009. The FDA did not cite the safety violations specifically.

Teva is the largest U.S. manufacturer of generic drugs for the animal health market, according to its website. The FDA’s court order will prevent the president and two principals at the company from resuming production until an independent inspector finds that the plant meets industry standards. Additional violations by Teva could cost them $45,000 in fines per day, or $7.5 million per year. “The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said FDA Associate Commissioner Michael Chappell.

Teva spokesperson Denise Bradley said that consent decree and the halt to producing drugs would not have any “material impact” on the company. She added that Teva does not disclose sales for the animal health unit. “[Teva] regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements,” Bradley said.

Teva Animal Health sells medicines for dogs, cattle, horses, sheep, cattle and swine. They also market the DVM Pharmaceuticals dermatologic products for animals. The company will now analyze each product, retrain production employees and revalidate equipment and processes, according to Bradley.

AUTHOR: Annette Hulbert