Australian vaccinemaker CSL Biotherapies, which landed in a boatload of trouble with the FDA and Australian authorities after children taking one of its vaccines began convulsing, has apparently satisfied U.S. regulators that its manufacturing is sound, netting a closeout letter as confirmation.
The form letter, issued earlier this month, ends two years of questions about CSL's manufacturing quality and whether its processes contributed to the problems with a flu vaccine that led to several children being hospitalized in 2010. Australian regulators prevented CSL from licensing Fluvax for children under 5 when the problems arose.
The FDA summoned CSL executives after inspectors found problems at the manufacturing plant in 2010. It followed up last year with a warning letter chastising the company, for among other things, doing only a limited analysis of the manufacturing process to determine why the adverse events spiked in 2010 relative to previous seasons. "There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 lots ... compared to lots from previous seasons," the letter says.
The agency found issues with CSL's inquiry into dark particles found in some vials. In one case, the agency refuted the company's contention that "the dark particles are not foreign to the product." The FDA said, "direct analysis indicates they are discolored influenza split virus," possibly containing other compounds, and ordered CSL to study the matter further.
In June, the drugmaker reported that a two-year study found that its manufacturing left higher vaccine component levels than other vaccinemakers but it couldn't determine why. The company speculated that the increased levels of seizures may be related to characteristics of the virus unique to the 2010 strain.
CSL spokeswoman Sharon McHale tells in-PharmaTechnologist that a different manufacturing problem that led regulators in Australia to quarantine 140 batches of human albumin for testing has also been satisfied.
- see the FDA warning letter
- get the FDA closeout letter
- read the in-PharmaTechnologist story
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