Indian drug manufacturer agrees to pay $50 million fine for concealing and deleting records before FDA inspection

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FKOL is a company primarily operating in the field of research, development and manufacturing of oncology drugs.

Indian drugmaker Fresenius Kabi Oncology Limited (FKOL) was charged for violating the Federal Food, Drug, and Cosmetic Act. 

The US Department of Justice (DOJ) announced that an Indian drug-making firm has agreed to plead guilty to concealing and destroying records before a 2013 US Food and Drug Administration’s (FDA) inspection of its plant and pay $50 million in fines and forfeiture.

A criminal information was filed in a federal court in the District of Nevada and unsealed on Tuesday that charged Fresenius Kabi Oncology Limited (FKOL) for violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA’s investigators. FKOL is a public company primarily operating in the field of Research & Development and manufacturing of oncology drugs.

As part of a criminal resolution, FKOL agreed to plead guilty to the offense, pay a criminal fine of $ 30 million, and another $20 million as forfeiture. The company has also agreed to implement a compliance and ethics program in order to prevent, detect, and correct violations of US law regarding the production of cancer drugs for terminally ill patients. 

Court documents indicate that FKOL owned and operated a production facility in Kalyani, West Bengal that produced active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States. The government claims that before the January 2013 FDA inspection of the facility, the company asked its employees to remove certain documents and records from the premise and computer, which revealed that it was violating FDA norms.

Acting Assistant Attorney General Brian Boynton from the Civil Division of the Justice Department said that FKOL by concealing and deleting manufacturing records “sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumers.” 

The DOJ statement said that “FKOL’s conduct put vulnerable patients at risk.”

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