Drug maker Fresenius Kabi Oncology pays $50 million after guilty plea to destroying records before FDA plant inspection

Drugmaker 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. 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 settlement with the Department of Justice, FKOL agreed to plead guilty to the misdemeanor offense and 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.

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.

“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.”