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Indian cancer drug manufacturer to pay $50 million for destroying records before FDA inspection

Asia   Fresenius Kabi Oncology

In a criminal information filed in federal court in the District of Nevada and unsealed today, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators.

Topics: India FDA

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 U.S. law relating to FKOL’s manufacture of cancer drugs intended for terminally ill patients.

According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States.

The government alleges that prior to a January 2013 FDA inspection of the Kalyani facility, FKOL plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements.

Kalyani plant employees removed computers, hardcopy documents, and other materials from the premises and deleted spreadsheets that contained evidence of the plant’s violative practices. ■

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