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news.Chiron Corporation has revealed that it expects the UK Medicines and Healthcare products Regulatory Agency, accompanied by FDA inspectors as observers, to conduct a series of inspections of Chiron's Liverpool manufacturing facility soon. The inspections will cover critical phases of the manufacture of Fluvirin influenza virus vaccine.
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In October 2004, the UK Medicines and Healthcare products Regulatory Agency (MHRA) suspended Chiron’s manufacturer’s license for the Fluvirin influenza vaccine at the Liverpool production site. Following the suspension, Chiron drastically slashed its guidance for future quarters, sending its shares plummeting down.
With this regulatory process, the remediation effort may advance toward the restoration of the facility’s license, if successive phases of manufacturing pass inspection by the MHRA. Chiron would receive sequential clearances to operate in certain areas as remediation continued in others.
Assuming successful completion of these inspections and restoration of the facility’s license, Chiron would expect a subsequent full cGMP (current good manufacturing practices) inspection by the FDA to close out the FDA warning letter issued December 9, 2004.