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CSL Biotherapies Receives US FDA Warning for GMP Violations at Vaccine Plant


6/28/2011 8:39:34 AM

Australia’s CSL Biotherapies has received a warning letter from the US FDA for GMP deviations at its vaccine production plant in Parkville, Victoria. The letter details a number of ‘significant objectionable conditions’ observed during an inspection earlier this month, several of which related to the scope of CSL’s investigation of ‘black particles’ detected in vaccines produced at the plant. Specifically, the US regulator said CSL failed to evaluate an interaction between the vaccine and its packaging that was identified as a potential root cause of the problem by a supplier several years ago.


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