After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, snagging a closeout letter from the FDA.
The FDA slapped the company with a warning letter in June 2011, questioning CSL's manufacturing quality. Its processes may have contributed to issues with a flu vaccine and led to the hospitalization of several children in 2010. Australian regulators put a halt to licensing Fluvax for children under age 5 at the time.
CSL's missteps included failing to adequately investigate dark particles found in some vials and completing only a limited analysis of the manufacturing process to determine why the adverse events shot up in 2010 compared with previous seasons. "There was no analysis of all critical parameters and critical processing steps to determine differences in the 2010 lots associated with adverse events reports compared to lots from previous seasons," the warning letter says.
As for the dark particles, the FDA investigation focused on multidose vials only. Analysis of the particles showed that they were "discolored influenza virus with the possible presence of mercury compounds," according to the warning letter. The company refuted this, saying the dark particles were not foreign to the product. The FDA disagreed.
The closeout letter comes a few weeks after CSL announced that the company's CEO, Brian McNamee, will step down next July. He'll be replaced by the current president of CSL Behring, Paul Perreault.
- read the closeout letter
- see the warning letter
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