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CSL Biotherapies: 'Warning Letter' issued by the United States' Food and Drug Administration

Behind the news

24 June 2011

This TGA behind-the-news article was published on 24 June 2011. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

The United States' Food and Drug Administration (FDA) has issued a 'Warning Letter' to CSL Biotherapies (CSL) following their audit of CSL's manufacturing facility. This is one of 160 similar letters issued to therapeutic goods manufacturers by the FDA this year. Broadly, the issues identified by the FDA are about inadequate documentation and investigation procedures at CSL in relation to CSL's handling of concerns about the quality of its influenza vaccine, Fluvax.

The Therapeutic Goods Administration (TGA) routinely audits CSL as part of its role in regulating therapeutic goods manufacturers and is aware of the issues raised by the FDA. The TGA audits CSL annually and, in addition, has undertaken five separate audits of CSL in the last 12 months following a higher than average rate of adverse reactions in children immunised with CSL's flu vaccine 'Fluvax' in 2010. The most recent audit occurred on 15 and 16 June 2011.

These audits revealed similar issues to those found by the FDA and confirmed that the findings do not relate directly to safety concerns.

Neither the TGA nor the FDA have identified manufacturing deficiencies that would warrant product recall or a change to the vaccine production process.

The TGA is working with CSL and the FDA to resolve the identified deficiencies and to ensure CSL remains fully compliant with manufacturing standards.

The TGA and FDA are collaborating to investigate the possible causes of the adverse reactions in children following immunisation with Fluvax in 2010.

Fluvax is not approved for use in children under the age of 5 years for the 2011 influenza season.

The Australian Technical Advisory Group on Immunisation (ATAGI) has advised that there is a strong preference for the use of either Vaxigrip or Influvac in children aged 5 years to less than 10 years. ATAGI advises that Fluvax may be used in children aged 5 years to less than 10 years when no timely alternative vaccine is available.

Further information about regulatory actions taken by TGA in relation to CSL's vaccine Fluvax can be found at: Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children.