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news.APP Pharmaceuticals, a subsidiary of Fresenius Kabi, has received a FDA warning letter regarding the company's Grand Island plant.
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FDA concluded an inspection at the facility in July 2011, to which the company responded detailing the corrective and preventative actions planned to address the Agency’s concerns.
In addition, the warning letter refers to the marketing status of five grandfathered generic products with a total annual sales volume of approximately €15m, the company said.
APP is expected to respond to the FDA within the required 15 working day time frame.
No material sales and earnings impact on Fresenius Kabi’s US business is expected, and Fresenius Kabi fully confirms its 2012 guidance.