There’s a reason they’re known as the “Indian Mafia”.
An Indian pharmaceutical company has been forced to pay $50 million after pleading guilty to concealing and destroying records prior to a FDA plant inspection, the DOJ announced on 3/23.
“Prosecutors charged Fresenius Kabi Oncology Ltd (FKOL) with violating the Food, Drug and Cosmetic Act by failing to provide its records to FDA investigators.
The company settled with the US Department of Justice by pleading guilty to a lesser misdemeanour charge plea and sentenced FKOL to pay a criminal fine of $30 million, forfeit an additional $20 million, and implement a compliance and ethics programme.
The charges were related to FKOL’s manufacture of cancer drugs intended for terminally ill patients. FKOL is the Indian unit of German company Fresenius Kabi. The US was investigating the unit over drug purity“.