MHRA and FDA to inspect Chiron's Liverpool manufacturing facility

Jan 13 2005

Chiron Corporation announced at a presentation at the 23rd Annual JPMorgan Healthcare Conference that the company anticipates that the UK Medicines and Healthcare products Regulatory Agency (MHRA), accompanied by U.S. Food and Drug Administration (FDA) inspectors as observers, will conduct a series of inspections of Chiron's Liverpool manufacturing facility.

The inspections will cover critical phases of the manufacture of Fluvirin influenza virus vaccine.

With this regulatory process, the remediation effort may advance toward the restoration of the facility's license, as 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.