German Drug Firm To Pay $50M In US Purity Case At India Site
LAS VEGAS (AP) — An international pharmaceutical company has agreed to plead guilty in a U.S. court and pay $50 million in a federal Food and Drug Administration drug purity investigation involving a site in India.
A federal prosecutor in Nevada says Fresenius Kabi Oncology Limited deleted and hid manufacturing records, putting "vulnerable patients at risk."
The company blamed employees it fired at a plant in Kalyani, West Bengal, India, for failing to provide records during an FDA inspection in 2013.
The company says patient safety is safeguarded, and the CEO in Germany expressed regret "that such events happened years ago."