Via CityNews.ca, Helen Branswell of The Canadian Press writes: Health Canada raises concerns about country’s only flu vaccine plant. Excerpt:
Health Canada has advised pharmaceutical giant GSK it wants to see an action plan for fixing problems at the country’s only flu vaccine production facility.
GSK was given 30 days in which to lay out a proposal and timeline for resolving the problems at the facility, Health Canada said in an emailed response to questions from The Canadian Press.
The deadline was contained in a Health Canada inspection report that GSK — formerly GlaxoSmithKline — received on July 3, the company said via email.
“We have 30 days to review and respond to the findings noted in their report and we are committed to doing so by August 4, 2014,” said the email from Michelle Smolenaars Hunter, communications manager for GSK Canada.
Specifics of the problems Health Canada identified at the Ste. Foy, Que., plant were not revealed, though the department said some relate to infractions raised by the U.S. Food and Drug Administration in a warning letter about the plant that it issued last month.
Health Canada said it is currently writing a summary report of its findings and will release it when it is completed.
“We will not hesitate to take firm and immediate action should a serious risk to public health and safety be found,” the department stated, though it noted the situation does not pose an immediate threat to the health of Canadians.
Programs to administer vaccine in advance of next winter’s flu season won’t begin across the country until late October or November.