Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) was sentenced to pay $50 million in fines and forfeiture after pleading guilty to concealing and destroying records prior to a 2013 U.S. Food and Drug Administration (FDA) plant inspection.
In a criminal information previously filed in federal court in the District of Nevada, the United States charged FKOL with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators. As part of a criminal resolution with the Department of Justice, FKOL agreed to plead guilty to the misdemeanor offense. U.S. District Judge Jennifer A. Dorsey accepted the company’s guilty plea and sentenced FKOL to pay a criminal fine of $30 million, forfeit an additional $20 million, and implement a compliance and ethics program designed to prevent, detect, and correct violations of U.S. law relating to FKOL’s manufacture of cancer drugs intended for terminally ill patients.
“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. “Today’s sentence holds the company accountable for its past conduct and seeks to ensure it will fully comply with its obligations to the FDA going forward.”
According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, India, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States. 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.
“Today’s sentencing reflects our office’s and the department’s commitment to holding accountable companies that disregard FDA regulations, at the risk of consumers’ health and safety,” said Acting U.S. Attorney Christopher Chiou for the District of Nevada. “Together with our agency partners, we will continue to ensure that drug manufacturers fully comply with their obligations to maintain the integrity of records and data.”
“FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality and purity of our medicines,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs of the FDA. “Today’s sentencing proves that we will continue to aggressively investigate and bring to justice those who attempt to subvert requirements that protect the public health.”
The FDA Office of Criminal Investigations, Los Angeles Field Office, investigated the case. The Central Bureau of Investigation in India provided invaluable assistance to U.S. authorities in the investigation of this matter. The Justice Department’s Office of International Affairs provided investigative assistance.
This case was prosecuted by Assistant Director Clint Narver and Trial Attorney Natalie Sanders of the Civil Division’s Consumer Protection Branch, with assistance from Assistant U.S. Attorney Nicholas D. Dickinson of the U.S. Attorney’s Office for the District of Nevada.