Newspaper article The Canadian Press

GSK Flu Vaccine Plant Inspection Finds 10 Issues Requiring Action: Report

Newspaper article The Canadian Press

GSK Flu Vaccine Plant Inspection Finds 10 Issues Requiring Action: Report

Article excerpt

Flu vaccine plant inspection finds 10 issues

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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. …

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