Fresenius Kabi Oncology Ltd. (FKOL), India, has reached an agreement with the U.S. Department of Justice (DOJ) that would conclude an investigation of events that took place in 2013.
In 2013, FKOL notified the FDA immediately upon discovering that certain employees at the company’s plant in Kalyani, India, had failed to provide relevant records during an FDA inspection. These individuals acted in violation of Fresenius Kabi’s compliance requirements, code of conduct and values. As a consequence, their employment was terminated immediately. Fresenius informed the public about these events in July 2013.
Patient safety was and has continued to be safeguarded at all times. Product supplied from this plant was within specifications. All necessary remediation actions were successfully implemented many years ago, and the plant has been fully operational ever since.
Under the agreement, which still must be reviewed and accepted by the United States District Court for the District of Nevada, FKOL will make a payment of USD 50 million. Given past accruals for this matter, the resolution will be net income neutral. The agreement includes a compliance addendum under which FKOL will build on its existing quality compliance management system to monitor compliance and provide the DOJ with regular reports on its effectiveness.
Mats Henriksson, CEO of Fresenius Kabi, said: “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. As a reliable partner of health care systems around the world, we continuously strive for the highest standards in pharmaceutical manufacturing.”