Teva Pharmaceutical Industries has acknowledged receiving an FDA Warning Letter citing problems at its active pharmaceutical ingredients (API) manufacturing facility in China.
The company said it received the letter on Monday following a routine current Good Manufacturing Practices (cGMP) inspection of the API facility, conducted by the agency on September 26–29, 2016.
“The letter cites concerns with manufacturing control and sampling processes,” Teva said yesterday in a regulatory filing. The company did not detail the concerns raised by the FDA, which at deadline had not posted the letter on its website.
“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,” the company also said, adding: “Teva will respond to the Warning Letter by May 1, 2017.”
Teva offered a similar reassurance tucked inside its Form 20-F annual report for 2016, filed February 15, saying it was “in the process of addressing quality issues raised in connection with an FDA audit of our active ingredient production facility in China.”
Teva’s website lists an API production plant and laboratories facility in Hangzhou, China, that opened in 2006.
According to the annual filing, Teva produces approximately 300 APIs for its own use as well as for sale to third-party companies, all made at the company’s 20 API production facilities, including one acquired as part of Teva’s $38.8 billion acquisition of Actavis Generics, completed last year.
Last year, Teva generated $776 million in API sales to third parties in 2016, up 4% from 2015. Accounting for currency fluctuations, sales increased 3%, mainly due to increases in sales in the U.S. and Europe, the company added.