Indian pharma firm told to pay Rs 363 crore fine for destroying records before USFDA inspection
As a part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanour offense, pay a criminal fine of USD 30 million, and forfeit an additional USD 20 million.
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Washington: An Indian drug manufacturer has 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 USD 50 million in fines and forfeiture, the Department of Justice has announced.
In a criminal information filed in federal court in the District of Nevada and unsealed on Tuesday, Fresenius Kabi OncPTIology Limited (FKOL) was charged with violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to Food and Drug Administration's (FDA) investigators.
As part of a criminal resolution, FKOL agreed to plead guilty to the misdemeanor offense, pay a criminal fine of USD 30 million, and forfeit an additional USD 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.
"By hiding and deleting manufacturing records, FKOL 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," said Acting Assistant Attorney General Brian Boynton of the Justice Department's Civil Division.
"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," the statement said.
"Pharmaceutical companies that obstruct FDA inspections jeopardize patient safety," said US Attorney Nicholas A. Trutanich for the District of Nevada.
According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, 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, the Department of Justice alleged.
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