Fresenius gets US FDA warning over Indian plant; divests biotech unit
Germany-based Fresenius Kabi has received a warning letter from the US Food and Drug Administration in relation to an inspection of its oncolytic active pharmaceutical ingredients (API) plant in Kalyani, India, conducted in January.
As a precaution, production at the plant was put on hold in January. The letter, dated July 1, details observations related to Good Manufacturing Practice (GMP) non-conformities regarding manufacturing, documentation practices and data integrity. Many of the data integrity items cited in the warning letter were self-identified by Fresenius Kabi post-inspection and shared with the FDA.
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