Teva reports receipt of FDA warning letter related to plant inspection
In a regulatory filing, Teva Pharmaceutical disclosed that the company received a Warning Letter from the U.S. Food and Drug Administration connected with an FDA current Good Manufacturing Practices inspection of the company's Godollo manufacturing facility, which was conducted January 21, 2016 through January 29, 2016. The letter cites deficiencies in manufacturing operations and laboratory controls, and in the company's data integrity program. "Teva has undertaken corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing. Teva will respond to the Warning Letter on November 4, 2016," the company stated.