German firm plea, US$50 million payment settles US drug purity probe
Signage is seen outside the United States Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on Aug 29, 2020. (File photo: Reuters/Andrew Kelly)
LAS VEGAS: An international pharmaceutical company pleaded guilty as planned on Tuesday (Mar 23) in a United States court after agreeing to pay US$50 million for destroying manufacturing records during a federal Food and Drug Administration (FDA) inspection in India.
Fresenius Kabi Oncology said in a statement that 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, 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 that 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 US$90 million in fines, plus restitution.
Fresenius Kabi is a subsidiary of healthcare group Fresenius SE & Co KGaA. The parent company is publicly traded in Europe.
Fresenius Kabi agreed to pay a US$30 million fine, forfeit US$20 million and implement a compliance program with reports to the US Justice Department.
