U.S. FDA warns GSK over problems at Quebec flu vaccine manufacturing plant
TORONTO - The company that makes much of Canada's annual flu vaccine has received a warning from the U.S. Food and Drug Administration.
GSK received a letter of warning from the FDA about conditions at its manufacturing facility at Ste-Foy, Que., where the company makes flu vaccine for the Canadian and U.S. markets.
The warning stems from an inspection of the plant conducted by FDA agents earlier this year.
The letter says the facility deviates from current good manufacturing practice requirements, the industry standards enforced by licensing agencies.
The letter raises concerns about the purified water system at the plant and other issues and gives the company 15 days in which to address the problems.
A statement from GSK says the company is making progress addressing the FDA's concerns and is committed to working with the regulatory agency to fully resolve all outstanding issues.
Read more Business News
- Smoke in the southPenticton / S. Okanagan
- Hwy. 33 reopensCentral Okanagan - 12:30 am
- Minor injuries in rolloverVernon / N. Okanagan
- Passengers leave stalled SkyTrains BC
|QHR Technologies Inc||1.15||0.00|
|Anavex Life Sciences||0.348||+0.008|
|Copper Mountain Mining||2.69||-0.01|
|Sunrise Resources Ltd||0.025||-0.005|
|Mission Ready Services||0.18||-0.03|
The mainstream media are finally waking up to something unusual in British Columbia – a labour shortage. If the experience of Alberta is a guide to our own future, the highly skilled labour will...
Photo: ContributedI have the pleasure of witnessing people delegate tasks quite often. Sometimes with tremendous success and sometimes with disastrous consequences. I have chaired a lot of committees...
Big Picture Euro debt woes re-emerge Europe’s debt woes jumped back into the headlines this week trumping other economic, geopolitical and corporate developments. Word that one of Portugal&rsquo...