January 12, 2015
Fresenius Kabi Receives FDA Status Upgrade for US Grand Island Facility
Fresenius Kabi has been informed by the U.S. Food and Drug Administration that its 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.
Fresenius is a global health care group, providing products and services for dialysis, hospital and outpatient medical care. In 2013, Group sales were €20.3 billion. On September 30, 2014, the Fresenius Group had 214,401 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz,
Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick