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.”

Fresenius Kabi is further expanding its Austrian facilities. The company will invest more than €60 million through 2023 to expand capacity and upgrade infrastructure at its production plant in Graz and packaging center in nearby Werndorf. The measures will be focused on the freeze-drying area and the lines for filling and packing glass bottles and ready-to-administer prefilled syringes.

“Prefilled syringes are a fast-growing market for us,” said Plant Manager Dr. Ruth Staubmann. “Many healthcare institutions and organizations recognize the clear advantages in terms of their rapid application and, above all, safety of use.” The expansion of the Graz plant will approximately double production capacity in this product category.

Fresenius Kabi produces liquid pharmaceuticals and clinical nutrition products for the Austrian and international markets in Graz. The site has special expertise in aseptic production and the manufacturing of complex products such as anesthetics, analgesics, anti-infectives and antibiotics. It also makes clinical nutrition products. In total, Fresenius Kabi currently has more than 900 employees in Graz. The number of additional jobs that will be created through the expansion cannot yet be determined.

In addition to the Graz plant and the packaging and logistics center in Werndorf, Fresenius Kabi’s Austrian operations include a research and development center in Grambach and a plant and distribution facility in Linz that specializes in the production of active ingredients and lactulose. The company employs a total of about 1,500 people in Austria.

Acetaminophen injection is now available in the United States in ready-to-administer freeflex^® bags, expanding the company’s anesthesia and analgesia portfolio. The drug is used in the hospital setting for pain management and fever reduction.

Icatibant injection, an FDA-approved and cost-effective alternative to treat acute attacks of hereditary angioedema in adults, expands the company’s generic drug portfolio. Icatibant Injection is supplied as a prefilled, single-use syringe that is self-administered subcutaneously at the patient’s home or doctor’s office. In conjunction with launching its first specialty IV drug in the U.S., Fresenius Kabi is also launching KabiCare in the U.S., a comprehensive patient support program with case managers, co-pay assistance programs, injection training, and a patient assistance program.

Diprivan® (Propofol) injection, an anesthetic, is the company’s first smart-labeled product with radio frequency identification (RFID) technology and the 20 mL vial is now available in this enhanced presentation in the U.S. The smart label enables hospitals to automatically identify, locate and manage their inventory. Fresenius Kabi expects to introduce numerous other products with RFID technology in the coming year.

Diprivan® (Propofol) injection, an anesthetic, is the company’s first smart-labeled product with radio frequency identification (RFID) technology and the 20 mL vial is now available in this enhanced presentation in the U.S. The smart label enables hospitals to automatically identify, locate and manage their inventory. Fresenius Kabi expects to introduce numerous other products with RFID technology in the coming year.

Beginning in Q4 2020, Fresenius Kabi will introduce smartlabels with radio frequency identification (RFID) technology for medications frequently used in the operating room in the U.S. The smart label enables hospitals to automatically identify, locate and manage their inventory. The first products in the smartlabel portfolio are anesthesia and analgesia products in prefilled syringes and vials.

Beginning in Q4 2020, Fresenius Kabi will introduce smartlabels with radio frequency identification (RFID) technology for medications frequently used in the operating room in the U.S. The smart label enables hospitals to automatically identify, locate and manage their inventory. The first products in the smartlabel portfolio are anesthesia and analgesia products in prefilled syringes and vials.