
An Indian drugmaker has agreed to plead guilty and pay a criminal fine of $30 million, and forfeit an additional $20 million for concealing and destroying records prior to a 2013 US Food and Drug Administration’s inspection of its plant, the Department of Justice has announced In a criminal information filed in federal court in the District of Nevada and unsealed on Tuesday, Fresenius Kabi Oncology Limited (FKOL) was charged with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to Food and Drug Administration’s (FDA) investigators.
“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 US consumers,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division.
“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,” the statement said.
“Pharmaceutical companies that obstruct FDA inspections jeopardise patient safety,” said US Attorney Nicholas A. Trutanich for the District of Nevada.
According to court documents, 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.
The government alleges that 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.