September 15, 2009

 

 FDA shuts down manufacturer of generic animal drugs

posted September 1, 2009
 
 

Teva Animal Health halted manufacture of veterinary drugs in August in response to an injunction filed by the Food and Drug Administration, which says the company failed to adhere to current good manufacturing practices.

Teva is a major manufacturer of generic animal drugs and also makes products under the DVM Pharmaceuticals brand name. The FDA reported finding violations of good manufacturing practices at Teva's facilities in St. Joseph, Mo., during inspections between 2007 and 2009. On July 31, the agency filed a consent decree of permanent injunction to halt Teva's operations.

Under the terms of the consent decree, Teva cannot resume manufacturing veterinary drugs until the FDA deems that the company has established adequate facilities and procedures. As of press time, the company remained shut down.

According to an April report by FDA inspectors, Teva's quality control unit failed in its responsibility and authority to monitor and implement quality control systems. Among the findings were that Teva did not reject products that failed to meet standards, did not extend investigations of discrepancies to other lots of the same product, and did not train employees adequately in good manufacturing practices.

In the event of future violations, the consent decree subjects Teva to fines of $20,000 for each day the company fails to comply with the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.