GlaxoSmithKline ($GSK) is under pressure from not one, but two regulatory bodies to get problems under control at a flu vaccine plant in Canada. After the FDA handed the company a warning letter late last month, Health Canada now says the pharma giant has a month to lay out a plan for resolving issues there.
As The Canadian Press reports, Health Canada has set a 30-day deadline for penning a remediation proposal and timeline for the facility, home of production for the company's FluLaval. 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 its June warning letter. Those included ongoing bacteria problems that forced the company to toss 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; it 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.
But that won't happen unless Glaxo provides the FDA with a rundown of the additional steps it will be taking to correct its manufacturing woes and comes in for a meeting to discuss them, the agency said last month. To that end, Smolenaars Hunter said the company has submitted a formal response to the FDA's warning letter.
2014 has already been a bit rocky on the pharma giant's vaccine production front. In January, Glaxo said it was reallocating this year's supply of Varilrix, its chickenpox vaccine, as well as Priorix Tetra, an MMRV combo, thanks to issues at a plant in Belgium.
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