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Canadian vaccine manufacturer raises concerns of Health Canada, FDA
Pharmacies that are preparing for the 2014-2015 flu season may be wondering about which vaccine suppliers they can trust. CTV News recently reported that a GlaxoSmithKline plant in Canada that manufactures flu vaccines for distribution in both that nation and the U.S. has struggled with inspections by the U.S. Food and Drug Administration, as well as Health Canada.
According to Reuters, the FDA sent the GSK plant in Canada a warning letter, dated June 12, stating that the company had to rectify various violations found in a facility that manufactures the Flulaval vaccine. Among the most prominent problems was an issue with a purified water system that left water tainted with Gram-negative bacteria and endotoxins that can potentially harm humans and animals. The contamination led to impurities in vaccine lots from 2011 and 2012. This year, 21 percent of GSK's flu vaccine lots were tainted with bacterial matter. The company maintains that its quality review process discards all tainted lots before they are available to the public.
During late June, GSK asserted there would be no shipment delays for its 2014-2015 vaccine, Reuters reported.
However, according to CTV News, GSK remained virtually silent after a 15-day deadline to correct the bacterial exposure problems, issued by the FDA, expired. Additionally, on July 3, Health Canada sent GSK a letter demanding that the company draft a proposal and timeline for resolving these issues.
"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," Michelle Smolenaars Hunter, communications manager for GSK Canada, told CTV News.
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