FDA Upgrades Fresenius Kabi NY Plant

Fresenius Kabi has been informed by the US Food and Drug Administration that its pharmaceutical manufacturing in Grand Island, New York, has achieved the upgraded status of “voluntary action indicated” (VAI) based on an October 2014 inspection. The status change is an improvement over “official action indicated” in which the company has been operating under; the company had received a Warning Letter in 2012.

The new VAI status permits FDA approval of new Fresenius Kabi products produced at the plant.

Source: Fresenius Kabi


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