Media Statement - CSL receive "Untitled Letter" from FDA

FDA - Untitled Letter

Melbourne, Australia — 29/06/2010

On 24 June 2010, CSL received an “Untitled Letter” from the United States Food and Drug Administration (FDA) relating to a routine inspection it conducted at our Parkville manufacturing facility in April 2010. The inspection related to CSL’s seasonal and pandemic influenza vaccines licensed for use in the United States.

The Untitled Letter can be found on the FDA's website.

While regulatory letters of this nature are not uncommon, CSL is taking the issues raised by the FDA very seriously. We place the utmost importance on the quality and safety of our therapies and are working actively to resolve the concerns as quickly as possible. We are currently preparing a detailed response and have made contact with the FDA to arrange a meeting

The FDA has stated that there is no direct connection between the increase in reports of fever and febrile convulsions reported in young children in Australia this season and the issues raised in the Untitled Letter. CSL’s investigations have also not identified a link between the FDA observations and the increase in side-effects.

The FDA has released a set of Questions and Answers in relation to above. The Q&A’s can be accessed on the FDA.s website.

CSL has a strong record of compliance and the Company will continue to be diligent in its efforts to meet all regulatory obligations.

Download the release:
Media Statement - CSL receive "Untitled Letter" from the FDA (0.2Mb)


Media Contact:
Sharon McHale
Senior Director Public Affairs
Phone: +61 3 9389 1506
Mobile: +61 409 978 314
Email: sharon.mchale@csl.com.au