German firm plea, USD50M payment settles US drug purity probe

LAS VEGAS (AP) — An international pharmaceutical company pleaded guilty as planned on Tuesday in a United States (US) court after agreeing to pay USD50 million for destroying manufacturing records during a federal Food and Drug Administration (FDA) 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 US. The company said patient safety was safeguarded.

The criminal case in Nevada came to light six weeks ago, when the agreement was unsealed in US District Court in Las Vegas. The company could have faced up to USD90 million in fines, plus restitution.

Fresenius Kabi is a subsidiary of Fresenius SE & Co KGaA healthcare group. The parent company is publicly traded in Europe.

Fresenius Kabi agreed to pay a USD30 million fine, forfeit USD20 million and implement a compliance programme with reports to the US Justice Department.