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Fresenius Kabi’s NY Facility Gets FDA Status Upgrade

New VAI classification permits FDA approval of new products

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By: Kristin Brooks

Managing Editor, Contract Pharma

Fresenius Kabi’s pharmaceutical manufacturing facility in Grand Island, NY, has achieved the upgraded status of voluntary action indicated (VAI) from the U.S. FDA following an October 2014 inspection. The facility previously operated under “official action indicated” status. The new VAI classification permits FDA approval of new Fresenius Kabi products at the plant.
 
The status change reflects improvements made at the plant since receiving a warning letter in 2012.

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