CSL Biotherapies receive close-out letter from US FDA

On August 10th, the US Food and Drug Administration (FDA) issued a statement that signalled the completion of their evaluation of CSL’s corrective actions in response to the Warning Letter received in June 2011.

CSL’s site at Parkville received the FDA warning letter due to “a number of significant objectionable conditions relating to the facility’s compliance with Current Good Manufacturing Practices (CGMP)” observed during a site audit.

The deviations observed included the failure to fully investigate why a higher than average rate of adverse events was reported in children immunised with their influenza vaccine (Fluvax) in 2010, and also failing to fully investigate the presence of black particles in some of its vaccine product vials.

The positive news of the close-out letter was further boosted by the announcement that the CSL group’s revenue was up 12% on 2011, and net profit was up by 4.5% to A$983m.

CSL are also planning to integrate the plasma facilities at Broadmeadows with CSL Behring, which will streamline its use of plasma, boosting its efficiency.

By Eoin Hanley
Senior Consultant-PharmOut