Fresenius Kabi Indian unit to pay $50 million fine for actions ahead of FDA inspection

Fresenius Kabi Oncology Limited (FKOL), the Indian unit of Germany-headquartered Fresenius Kabi, has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced yesterday.

In a criminal information filed in federal court in the District of Nevada and unsealed yesterday, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators. As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanor offense, pay a criminal fine of $30 million, and forfeit an additional $20 million. FKOL also agreed to implement a compliance and ethics program designed to prevent, detect, and correct violations of US law relating to FKOL’s manufacture of cancer drugs intended for terminally ill patients.

Sought to obstruct the FDA’s regulatory authority