News

Posted On: 06/22/2006

Feds Fault Chiron for Lax Cleanup of Flu Shot Plant

PharmaManufacturing.com

Editor's Note: Following are the first two paragraphs of a San Francisco Chronicle article analyzing a new report on FDA's exhaustive inspection last summer of Chiron Corp.'s Liverpool, England, vaccine manufacturing facility. A link to the full article, as well as links to additional articles on PharmaManufacturing.com, are provided below.

Chiron Corp.'s troubled flu shot factory in England earned poor marks from federal regulators last summer, just weeks before it expected to resume shipments to the United States — and despite a 10-month effort to turn the plant around, according to a newly released report.

The report by the U.S. Food and Drug Administration, obtained by The [San Francisco] Chronicle under a Freedom of Information Act request, details the results of a nine-day inspection the FDA conducted in July. Today, the same Liverpool plant is in full production for this fall's flu shot season, and the company expects to produce up to 40 million doses for the U.S. market. It also has been tapped to fill a $62.5 million federal contract to make an experimental human vaccine against the H5N1 strain of bird flu.

Click here to read the entire article from The San Francisco Chronicle.

Pharmaceutical Manufacturing magazine and PharmaManufacturing.com have extensively covered the history of Chiron and its Liverpool facility. Key articles include:

• "Chiron's Curse," Jan. 2005



• "Chiron Flu Vaccine Plant Shut Down by UK Regulators," Oct. 2004



• "Risk Management Still Eludes Vaccine Manufacturers," Dec. 2004.