Fresenius Kabi pays $50 million to settle criminal charges

India-based Fresenius Kabi Oncology Limited (FKOL) has pleaded guilty to destroying and concealing records, and agreed to pay $50 million in fines and forfeitures, the Justice Department said Tuesday. The charges are linked to a 2013 inspection by FDA of KFOL’s factory in Kalyani, India. Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division said: “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.” FDA and the Justice Department said FKOL systematically removed records and equipment from its Kalyani facility ahead of a January 2013 FDA inspection. Following that inspection, FDA sent the firm a warning letter in July 2013, pointing to numerous irregularities found by inspectors. FDA cited such issues as FKOL’s practice of blending failed batches of active pharmaceutical ingredients with batches that had passed specifications, and the improper use of test and “demo” chromatogram data files.