Comments
An Indian drug manufacturer has been sentenced to pay $50 million in fines and forfeiture after pleading guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration (FDA) plant inspection, the Department of Justice said.
Fresenius Kabi Oncology Limited (FKOL) was previously criminally charged by the United States with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators.
FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drugs distributed to the United States.
As part of a criminal resolution with the Department of Justice, FKOL agreed to plead guilty to the misdemeanour offense.
US District Judge Jennifer A Dorsey accepted the company’s guilty plea and sentenced FKOL on Tuesday to pay a criminal fine of $30 million, forfeit an additional $20 million, and 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 concealing and destroying drug manufacturing records, FKOL undermined FDA’s regulatory authority and placed vulnerable consumers at risk,” said Acting Assistant Attorney General Brian M Boynton of the Justice Department’s Civil Division.
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. Employees at the Kalyani plant removed computers, hardcopy documents, and other materials from the plant and deleted spreadsheets that contained evidence of the plant’s non-compliant practices.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.