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Flu vaccine facility has 10 infractions during inspection, but safe

Written by: QMI Agency
Jul. 23, 2014

The logo of GlaxoSmithKline (GSK) is seen on its office building in Shanghai in this July 12, 2013 file photo. (REUTERS/Aly Song/File)


A federal government inspection of Canada's only flu vaccine manufacturer found 10 areas where improvements are needed, but said none of the issues would affect Canadians' health.

The inspection of the GlaxoSmithKline facility in Quebec City's Sainte-Foy area was conducted in June, Health Canada said in a report posted to its website Tuesday.

It is not unusual for there to be a number of infractions at a facility, the report noted. The inspectors did not see any critical problems, but seven issues were deemed "major," while three were classified as "other."

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Some of the major problems involved the manufacturing controls on a line making two vaccines that are not yet marketed in Canada, the report said.

To ensure there is enough of the flu vaccine this fall for Canadians, the company has reverted to a process used in 2012 and had been safely used to produce the vaccine for several years, the report said.

"The 2014 inspection did not identify any deviations that would affect the safety or quality of the product to be supplied, nor pose a risk to the health and safety of Canadians," the Health Canada report said.

The U.S. Food and Drug Administration visited the plant in April and noted several significant deviations from GMP (good manufacturing practices) standards. The company pledged to fix the problems, but Health Canada noted because of the short time between the U.S. and Canadian inspections, not all the issues were addressed.

Canadian inspectors gave the facility a compliant rating, but did impose one "term and condition" to the plant's licence that will require officials to inform Health Canada 90 days before it resumes making the two vaccines not currently sold in Canada.

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