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Last month, the FDA chided GlaxoSmithKline ($GSK) over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.
Health Canada has set a 30-day deadline for penning a remediation proposal and timeline for the facility, The Canadian Press reports. GSK Canada spokeswoman Michelle Smolenaars Hunter told the news service the company was committed to responding to the agency's findings by Aug. 4.
While Health Canada didn't go into specifics on the issues it found during an inspection at the Ste. Foy, Quebec plant, it did say some of them relate to the concerns the FDA raised in the warning letter it handed GSK late last month. Those included ongoing bacteria problems that have forced the company to throw out more than 20% of the lots it has produced this year alone.
The Ste. Foy plant figures significantly into GSK's plans for the upcoming flu season; Glaxo expects to provide between 28 million and 33 million doses of flu vaccine to the U.S. market this fall, with about 23 million of that coming from the troubled facility, Smolenaars Hunter told The Canadian Press.
And in Canada, Ste. Foy is contracted to produce 53% of the seasonal flu vaccines government will offer this fall, coming out to about 6.36 million of the 12 million doses the country has ordered, according to the Press. Competitors Novartis ($NVS) and AstraZeneca ($AZN), both of which also chip in to Canada's supply, have said they could step up their contributions if necessary.
While Health Canada told the news service GSK has assured it that problems at Ste. Foy won't affect the company's ability to deliver vaccines for the Canadian market this fall, it also said the company's revised plan would "adhere as closely as possible" to its original schedule, leaving open the possibility of a delay.
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Special Reports: Top 5 Vaccine Companies by Revenue - 2012 - GlaxoSmithKline | Major FDA vaccine approvals of 2012 - FluLaval