Fresenius Kabi fined $50 million by DoJ for offenses in India

24 March 2021

Fresenius Kabi Oncology Limited (FKOL) has been sentenced to pay $50 million in fines and forfeiture after pleading guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration plant inspection in India.

In a criminal information previously filed in federal court in the District of Nevada, 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 with the Department of Justice, FKOL agreed to plead guilty to the misdemeanor offense.

US District Judge Jennifer Dorsey accepted the company’s guilty plea and sentenced FKOL to pay a criminal fine of $30 million, forfeit an additional $20 million, and 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.

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