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