TORONTO – A recent Health Canada inspection of the country’s only flu vaccine production plant identified 10 issues that need to be addressed, a report from the regulatory agency reveals.
The summary report of the June inspection said none of the problems found poses a critical risk to public health, but seven fall into the major observation category, meaning they are signs production is not consistently hitting required standards.
The regulatory agency posted the summary report from the inspection of the GSK-owned plant on its website Tuesday evening after the end of the business day.
The production facility at Ste. Foy, Que., was issued a warning letter last month by the U.S. Food and Drug Administration, which raised concerns about bacterial contamination problems in the plant.
The FDA noted GSK – formerly known as GlaxoSmithKline – has repeatedly had to discard batches of vaccine made at the facility because of bacterial counts that registered above specified limits. In a letter dated June 12 it said 21 per cent of this year’s product could not be released to the market.
The Ste. Foy plant has contracts to produce 53 per cent of Canada’s seasonal flu vaccine for the coming flu season as well as 23 million doses for the U.S. market.
The Health Canada summary report sheds a little more light on the problems at the plant, which also holds a 10-year contract to produce pandemic flu vaccine for Canada when needed.
The regulatory agency said the facility was given a “compliant” rating because none of the deviations identified “would affect the safety or quality of the product to be supplied, nor pose a risk to the health and safety of Canadians.”
It is not uncommon to have a number of issues raised during an inspection, because vaccine production processes are complex and the safety standards plants must meet are high, the report said, suggesting 10 observations is “acceptable.”
Health Canada inspects the plant every two years and was planning its scheduled 2014 review when it learned about the FDA inspection and the problems it identified. The two agencies have been sharing information and the company has been co-operating with both, all parties have said.
The report said some of the major observations Health Canada found relate to two new vaccines GSK had started to make at the Quebec facility. They have been licensed for use in Canada, but are not currently sold here.
Corrective actions the company took did not solve the observed problems to the satisfaction of Health Canada inspectors, the report said, and the company reverted to a process it has used successfully in the past in order to ensure that it could fill its 2014-15 Canadian order.
Health Canada, which has given GSK until Aug. 4 to produce a plan for how it will fix the various issues, affixed a condition to the production facility’s licence. GSK must give Health Canada 90 days notice before it resumes making the two vaccines currently not being produced, so that the agency can take further action if necessary.
Other problems the report highlighted include the fact that changes to the water quality systems made to try to fix recurring bacterial contamination problems did not resolve the issue. It also notes that a piece of filling equipment was not being sufficiently monitored to detect microbial levels.
In an email, GSK said it is fully committed to working with both regulatory agencies to resolve the problems. It also said the company had no objection to the 90-day condition Health Canada has imposed.