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.
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The company says patient safety is safeguarded, and the CEO in Germany expressed regret "that such events happened years ago."
