Indian drugmaker to pay $50 million fine for destroying records
Fresenius Kabi Oncology Limited agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration's inspection of its plant and pay $50 million in fines and forfeiture. In criminal information unsealed on Tuesday, FKOL was charged with violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to Food and Drug Administration investigators.
FKOL will implement a compliance and ethics program
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 US law relating to FKOL's manufacture of cancer drugs intended for terminally ill patients, a media release said.
FKOL's actions hindered FDA from doing its job
"By hiding and deleting manufacturing records, FKOL sought to obstruct FDA's regulatory authority and prevent it from doing its job of ensuring the purity and potency of drugs intended for US consumers," said Acting Assistant Attorney General Brian Boynton of the Justice Department's Civil Division.
Employees allegedly told to remove, delete certain records from premises
According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, that manufactured active pharmaceutical ingredients used in various cancer drug products distributed to the United States. The government alleged 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.
Such actions put patients at risk: Boynton
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, the Department of Justice alleged. "FKOL's conduct put vulnerable patients at risk. The Department of Justice will continue to work with FDA to prosecute drug manufacturers who obstruct these inspections," Acting Assistant Attorney General Boynton said.
