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.
Denise Bradley, a spokeswoman for the company, said Teva "regretted 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 those actions included a "complete analysis of each individual product, retraining all of our production employees and revalidating our equipment, processes and methods."
Among other violations, the government's suit alleged that 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.
The suit charged that Teva officials had taken part in five regulatory meetings with the FDA between June 2007 and June 2009 but had “shown that they are unwilling or unable to take the necessary steps to prevent recurrence” of Good Manufacturing Practice violations.
Besides naming Teva Animal Health, the suit names three Teva officials as defendants: David S. Cunningham, president of Teva Animal Health; Kenneth P. Lavin, senior director of regulatory compliance at Teva Pharmaceuticals USA, which owns Teva Animal Health; and Ronald A. Schultz, senior vice president of quality at Teva Pharmaceuticals USA.
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.
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