Indian drugmaker to pay $50mn in fine for destroying records before FDA inspection
Team Udayavani, Feb 10, 2021, 12:31 PM IST
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 Oncology 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 misdemeanour 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 programme 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 jeopardise 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.
Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.
Top News
Related Articles More
Internal divisions leave open question whether Gandhi’s vision will ever be fully realised in India: Bill Clinton
COP29: India rejects new USD 300 billion climate finance deal
Royal tour of India in offing for King Charles, Queen Camilla: Report
Indian-American leaders applaud PM Modi for inclusive growth in India
COP29: Civil society protests climate finance proposal, calls for ‘no deal’ over ‘bad deal’
MUST WATCH
Latest Additions
Boy chokes to death after eating more than three pooris together
Internal divisions leave open question whether Gandhi’s vision will ever be fully realised in India: Bill Clinton
PWD, Google Maps officials booked in Bareilly bridge death case
WhatsApp, Gmail banned from use for transmission of official documents in Jammu and Kashmir
At 13 years, Vaibhav Suryavanshi becomes IPL’s youngest-ever player
Thanks for visiting Udayavani
You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.