Health Canada has given GSK 30 days to present a proposal and timeline for resolving the quality problems recently identified at the Ste Foy, Quebec Flulaval manufacturing facility.
In June, the Flulaval facility was cited by the U.S. FDA for failing to meet quality control standards. The FDA said controls for the purified water system at the plant were inadequate and that some Gram-negative bacteria identified in water used for equipment washing had been implicated in product contamination issues at the facility as far back as 2011.
The FDA warning letter -- dated June 12 -- gave GSK 15 working days in which to fix the bacterial contamination problems identified during a regularly scheduled inspection of the facility in early April.
The 30-day Canadian deadline was contained in a Health Canada inspection report received by GSK on July 3, 2014.
GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season.
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