APP Pharmaceuticals receives FDA warning letter regarding Grand Island plant - no material financial impact expected

(PresseBox) ( Bad Homburg, )
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.

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.
The publisher indicated in each case is solely responsible for the press releases above, the event or job offer displayed, and the image and sound material used (see company info when clicking on image/message title or company info right column). As a rule, the publisher is also the author of the press releases and the attached image, sound and information material.
The use of information published here for personal information and editorial processing is generally free of charge. Please clarify any copyright issues with the stated publisher before further use. In the event of publication, please send a specimen copy to