LAKE ZURICH, Ill., January 12, 2015 – Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, announced today it has been informed by the U.S. Food and Drug Administration that the company’s pharmaceutical manufacturing facility in Grand Island, N.Y., has achieved the upgraded status of voluntary action indicated (VAI) following an October 2014 inspection. The status change is an improvement from the “official action indicated” status the facility had been operating under.
The new VAI classification permits FDA approval of new Fresenius Kabi products at the plant.
The status change reflects the improvements that have been made at the plant since receiving a warning letter in 2012. Fresenius Kabi remains committed to continuous improvement and compliance in its operations worldwide.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in lifesaving medicines and medical devices for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.