Fresenius Kabi Oncology pleaded guilty to concealing and destroying records before a 2013 FDA inspection of its API manufacturing site in Kalyani, India, according to the the U.S. Department of Justice.
Fresenius Kabi Oncology (FKOL), the India-based oncology division of German drugmaker Fresenius Kabi, agreed to plead guilty to the misdemeanor offense, pay a criminal fine of $30 million, and forfeit an additional $20 million. FKOL also agreed to 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.
The government alleges that prior to a January 2013 FDA inspection of the Kalyani facility, which manufactures APIs used in various cancer drug products distributed to the U.S., 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 premises and deleted spreadsheets that contained evidence of the plant’s violative practices.
Fresenius informed the public about these events in July 2013. “While we are pleased to have reached this resolution, we regret that such events happened years ago in one of our plants. In line with our commitment to highest ethical and quality standards, we immediately and consequently took all necessary measures to remedy the situation in full cooperation with the authorities," stated Mats Henriksson, CEO of Fresenius Kabi in a press release.
Read the DOJ press release
