Teva Receives FDA Warning Letter on Hungary Site
Teva Pharmaceutical Industries has received a Warning Letter on October 14, 2016, from the US Food and Drug Administration (FDA) regarding a cGMP inspection of the company’s Godollo, Budapest, Hungary manufacturing facility, which was conducted January 21, 2016 through January 29, 2016, according to an Octoberr 18, 2016 6-K filing with the US Securities and Exchange Commission. The letter cites deficiencies in manufacturing operations and laboratory controls, and in Teva’s data-integrity program. Teva said it 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 said it will respond to the Warning Letter on November 4, 2016.