STAT+: Drug maker agrees to plead guilty to hiding and destroying records before FDA inspection
A unit of Fresenius Kabi, a major supplier of infused and intravenously administered drugs, has agreed to plead guilty to hiding and destroying records before a 2013 plant inspection by the Food and Drug Administration, and will also pay $50 million in fines and forfeiture.
At issue is a plant operated in West Bangal, India, by Fresenius Kabi Oncology, which makes active pharmaceutical ingredients for various cancer medicines distributed in the U.S. According to the U.S. Department of Justice, plant managers directed employees to remove computers and documents, and delete other records that indicated proper manufacturing procedures were not being followed.
