Indian Cancer Drug Manufacturer to Plead Guilty to Concealing Records from FDA

According to a Department of Justice (DOJ) press release, Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to plead guilty to concealing and destroying records prior to a 2013 U.S. Food and Drug Administration (FDA) inspection. FKOL has agreed to pay $50 million in fines and forfeiture.

Acting Assistant Attorney General Brian Boynton said of the crime, “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 U.S. consumers. 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.”

FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, India that manufactured active pharmaceutical ingredients (APIs) used in cancer drugs distributed to the United States. Court document allege that FKOL directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients against FDA requirements.

Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs of the FDA, said of the crime, “FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality and purity of our medicines. Any attempt to obstruct or interfere with these inspections threatens the public health. We will continue to aggressively investigate and present any such obstruction for prosecution.”