Mark Metherell
theage.com.au
July 3, 2010
AUSTRALIAN vaccine company CSL is again under scrutiny because of a failure to meet United States manufacturing standards.
However, the problems are not linked to the unexplained surge in convulsions among infants vaccinated with its product, regulators say.
The US Food and Drug Administration (FDA) has notified CSL of ”deviations” in good manufacturing practice in that CSL had failed to investigate thoroughly an ”unexplained discrepancy” in the formation of dark particles in its Alfuria flu vaccine, produced for the US market. The FDA report, based on a survey of the Melbourne plant undertaken in April, came just as the first of 100 cases of convulsions among infants vaccinated with CSL’s Fluvax flu product were occurring.
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