Indian drug maker sentenced to pay $ 50 million in fines

An Indian drugmaker has been sentenced to pay $ 50 million in fines and seizure after pleading guilty to hiding and destroying records before a 2013 US Food and Drug Administration (FDA) plant inspection, the Justice Department said.

Fresenius Kabi Oncology Limited (FKOL) was previously criminally charged by the United States with violating the Federal Food, Drug and Cosmetic Act for failing to provide certain records to FDA investigators.

FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, manufacturing active pharmaceutical ingredients (APIs) used in various pharmaceutical pharmaceutical products distributed in the United States.

As part of a criminal resolution with the Department of Justice, FKOL agreed to plead guilty to the crime of misdemeanor.

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US District Judge Jennifer A. Dorsey accepted the company’s guilty plea and on Tuesday handed FKOL a criminal fine of $ 30 million, an additional $ 20 million fine, and implementing a compliance and ethics program created to prevent, detect and correct violations of the US Accepted for. A media release stated that FKOL’s law relating to the manufacture of cancer drugs, which is intended for sick patients.

Brian M., acting Assistant Attorney General of the Civil Division of the Department of Justice. “By concealing and destroying drug manufacturing records, FKOL undermined the FDA’s regulatory authority and put vulnerable consumers at risk,” Boynton said.

FDA inspection of the Kalyani facility prior to January 2013, FKOL plant management had instructed employees to remove certain records from the premises and other records from computers making drug paraphernalia in violation of FKOL requirements. Kalyani plant employees removed computers, hardcopy documents and other materials from the plant and removed the spreadsheet, which contained evidence of the plant’s non-complex practices.