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 drug products 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 USD30 million, forfeit an additional USD20 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. Kalyani plant employees removed computers, hardcopy documents, and other materials from the plant and deleted spreadsheets that contained evidence of the plant’s noncompliant practices