Page 35 - The Indian EYE 021221

NORTH AmERIcAN Newsline February 12, 2021 | The Indian Eye 35

Fresenius KaBi onCology ltd

drug firm agrees to pay $50

million fine in uS

he US Department of Justice (DOJ) announced that an In-
dian drug-making firm has agreed to plead guilty to con-
Tcealing 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 Dis-
trict 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 operat-
ing 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 move certain documents and records from the premise and com-
a compliance and ethics program in order to prevent, detect, and puter, which revealed that it was violating FDA norms.
correct violations of US law regarding the production of cancer Acting Assistant Attorney General Brian Boynton from the
drugs for terminally ill patients. Civil Division of the Justice Department said that FKOL by con-
Court documents indicate that FKOL owned and operated a cealing and deleting manufacturing records “sought to obstruct
production facility in Kalyani, West Bengal that produced active the FDA’s regulatory authority and prevent the FDA from doing
pharmaceutical ingredients (APIs) used in various cancer drug its job of ensuring the purity and potency of drugs intended for
products distributed to the United States. US consumers.”
The government claims that before the January 2013 FDA in- The DOJ statement said that “FKOL’s conduct put vulnerable
spection of the facility, the company asked its employees to re- patients at risk.”

www.TheIndianEYE .com