U.S. sues Teva Animal Health for alleged drug act violations
Posted: July 31st, 2009 - 5:30pm
Source: Kansas City Star
The federal government today sued Teva Animal Health Inc., saying government inspections had uncovered adulterated animal drugs at the company’s main facilities in St. Joseph.
The lawsuit, filed in the U.S. District Court for the Western District of Missouri, charged that three inspections by the Food and Drug Administration between 2007 and 2009 “documented numerous” Good Manufacturing Practice violations at the facilities.
Among other violations, the suit alleged Teva had failed to:
Reject drug products that did not meet established specifications;
Assure that products had the “identity, strength, quality and purity” they are represented to have;
Conduct adequate equipment maintenance;
Provide adequate training for employees; and
Establish a quality control unit.
A unit of Israeli pharmaceutical giant Teva Pharmaceutical Industries, Teva Animal Health is the largest manufacturer of generic drugs for animals in the United States. Formerly IVX Animal Health, the company was acquired by Teva in 2006.