Fresenius Kabi pays $50M for destroying records ahead of FDA probe

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Fresenius Kabi Oncology pleaded guilty to concealing and destroying records before a 2013 FDA inspection of its manufacturing site in Kalyani, India, the U.S. Department of Justice announced Feb. 9.

The unit, the India-based oncology division of German drugmaker Fresenius Kabi, also agreed to pay the U.S. a $30 million fine and forfeit another $20 million.

The FDA investigation took place at an Indian manufacturing site that produces ingredients for oncology drugs used in U.S. patients. According to court documents, the plant's managers told employees to delete spreadsheets and remove computers, hardcopy documents and other materials that would have exposed manufacturing practices that did not meet FDA requirements.

Fresenius Kabi also promised to establish expanded compliance and ethics programs, which include regular reports to the Justice Department.

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