http://www.theaustralian.com.au/national-affairs/csls-us-licence-at-risk-over-flu-vaccine-failings/story-fn59niix-1226080246767
THE US medicines watchdog has threatened to revoke the licence of Australian drug giant CSL, citing manufacturing deficiencies and an inadequate investigation into why its flu vaccine caused fits in children.
The US Food and Drug Administration also questions CSL's quality control in an official warning letter released yesterday - a year after the regulator demanded that CSL rectify problems identified in a previous audit of the company's Parkville laboratory in Melbourne.
Australia's drugs regulator, the Therapeutic Goods Administration, yesterday revealed that it, too, had sent letters to CSL after five audits flagged problems ranging from "inadequate investigations" to "poor management of corrective and preventative actions", and "inadequate" cleaning and testing regimes.
csl's us licence at risk over flu vaccine
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