Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) revealed in a filing with the US Securities and Exchange Commission that, on April 10, it received a Warning Letter from the US Food and Drug Administration.
The Warning Letter is connected with a routine FDA current Good Manufacturing Practices (cGMP) inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in China, which was conducted in September 2016.
The letter cites concerns with manufacturing control and sampling processes. Teva is already in the process of undertaking 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 and Teva, the world’s biggest generic drugs producer, says it will respond to the Warning Letter by May 1, 2017.
Last October, a Teva manufacturing facility in Hungary was also issued with a Warning Letter, after an earlier inspection had found a range of deficiencies in the site’s laboratory and monitoring practices.