An Australian plant has fallen under the FDA's scrutiny. The agency cautioned vaccine manufacturer CSL after inspectors found problems at a plant that turns out flu vaccine, and--in a rare move--asked to meet with senior company officials to talk about those problems.
CSL fell short of cGMP requirements in several areas, notably by failing to thoroughly investigate unexplained product discrepancies and problems with particular batches of its Afluria vaccine. The company also failed to test other vaccine batches for problems after particles were found in some Afluria multi dose vials, the agency says.
And then there were problems with vial stoppers. The FDA says that CSL's stopper supplier disclosed that its rubber stoppers may react with thimerosal, a preservative used in vaccines. But the company kept using those stoppers in lots of Afluria and H1N1 vaccine that contain thimerosal, the agency maintains.
There were other violations, but all the problems fell short of the threshold for an actual warning letter. Instead, the agency delivered its assessment in an untitled letter to CEO Brian McNamee. "We would like to meet with you and other senior management at CSL Biotherapies to further discuss the issues cited in this letter and how you will address them going forward," the agency writes.
- see the FDA letter
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- check out the Reuters story