FDAnews
www.fdanews.com/articles/67789-inspections-may-lead-to-getting-license-back-chiron-ceo-says

INSPECTIONS MAY LEAD TO GETTING LICENSE BACK, CHIRON CEO SAYS

January 20, 2005

Chiron President and CEO Howard Pien has confirmed that the fate of the company's Liverpool, England, manufacturing facility will hinge on a series of upcoming inspections to be performed by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Pien, speaking at the 23rd Annual JPMorgan Healthcare Conference, said each inspection will examine a different component of the plant's manufacturing process. Each successful inspection could give Chiron clearance to conduct certain operations at the plant, while the company continues with remediation in other parts of the facility, he said. The FDA is expected to join the MHRA inspections as observers, Pien added.

Pien did not disclose when the inspections will begin.