LAS VEGAS (AP) — An international pharmaceutical company pleaded guilty as planned Tuesday in a U.S. court after agreeing to pay $50 million for destroying manufacturing records during a federal Food and Drug Administration inspection in India.
Fresenius Kabi Oncology Ltd. said in a statement it was pleased to conclude the drug purity investigation after eight years and regretted that “such events happened years ago at one of its plants.”
The company said it informed the public in July 2013 that employees at a company plant in Kalyani, West Bengal, India, had been fired for failing to provide records during an FDA inspection earlier that year.
The plant makes cancer drugs distributed in the U.S. The company said patient safety was safeguarded.