APP Pharmaceuticals receives FDA warning letter regarding Grand Island plant - no material financial impact expected
February 24, 2012
Bad Homburg v.d.H.
APP Pharmaceuticals ("APP"), a subsidiary of Fresenius Kabi, has received a warning letter dated 22 February 2012 from the New York District FDA office regarding the Company's Grand Island plant. The warning letter follows an inspection at the facility which concluded in July 2011. The Company responded on 27 July 2011 detailing the corrective and preventative actions planned to address the Agency's concerns, and since then has made significant progress in collaboration with the FDA in remedying these issues. In addition, the warning letter refers to the marketing status of five 'grandfathered' generic products with a total annual sales volume of approx. €15 million.
The Company has full confidence in the quality of the products it has distributed from the Grand Island facility and expects to continue production at the plant. We believe that the ongoing enhancement efforts can be successfully completed without disrupting output.
Both APP and Fresenius Kabi are committed to the highest standards of quality and compliance in manufacturing across its global operations. We regard our relationship with the FDA as critical to both our past and future success, and we will continue to work constructively and expeditiously with the Agency to resolve all the issues addressed in the warning letter.
APP will respond to the FDA within the required 15 working day time frame. No material sales and earnings impact on Fresenius Kabi's U.S. business is expected, and Fresenius Kabi fully confirms its 2012 guidance.
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Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2011, Group sales were €16.5 billion. On December 31, 2011, the Fresenius Group had 149,351 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), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick