U.S. FDA warns over problems at flu vaccine plant

The company that makes much of Canada’s annual flu vaccine and has the country’s pandemic flu vaccine contract has been issued a warning from the U.S. Food and Drug Administration.

TORONTO — The company that makes much of Canada’s annual flu vaccine and has the country’s pandemic flu vaccine contract has been issued a warning from the U.S. Food and Drug Administration.

The letter, dated June 12, laid out a number of concerns, many related to sterility issues and microbial contamination problems at the GSK manufacturing facility in Ste. Foy, Que.

The problems were identified during an FDA inspection of the plant from March 31 to April 9.

The U.S. regulatory agency noted that since 2011 multiple batches of flu vaccine from the Quebec plant have been rejected.

It warned that if the problems identified are not fixed promptly the company’s licence to produce flu vaccine for the U.S. market could be suspended or revoked.

“The deficiencies described … at the close of the inspection referenced above and this letter are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates,” the letter stated.

“You should take prompt action to correct these deviations.

“Failure to promptly correct these deviations may result in regulatory action without further notice.

“Such actions may include license suspension and-or revocation.”

Health Canada, which licenses vaccines in this country, said it is aware of the situation and is working closely with the company and the FDA on the matter.

In an emailed response to questions, the department said Canada has flu vaccine purchasing contracts with a number of other suppliers and can source additional vaccine from them if the need arises.

The FDA letter said the Quebec facility deviates from current good manufacturing practice requirements, the industry standards enforced by licensing agencies.

It raised concerns about the purified water system at the plant and gave the company 15 working days in which to address the problems. If problems cannot be fixed within that time frame, the company must write to explain the delay.

The agency also asked for a meeting with senior management of both GSK and the Quebec facility to discuss the identified problems and the proposed solutions.

In a written statement GSK said the company is making progress toward addressing the FDA’s concerns and is committed to working with the regulatory agency to fully resolve all outstanding issues.

Just Posted

SUV smashes through fences and deck in Anders

Driver taken to hospital after SUV veered off 30th Avenue into Anders

Red Deer’s new ‘equity co-ordinator’ will promote tolerance

Andrea Lacoursiere was hired by city with Alberta Human Rights funding

More bridge work this summer in Red Deer’s Coronation Park

The park’s north bridge is being rebuilt to ensure safety

Man badly injured in off-road vehicle collision on Saturday

Incident happened in Mountain View County about 10:50 p.m.

Heat warning in effect for Central Alberta

Environment Canada has issued a heat warning for Central Alberta. Residents in… Continue reading

CFIA inspects after video shows pigs crammed into B.C. transport truck

The video shows pigs piled on top of one another in a transport truck on a “sweltering” hot day last week

‘City of icebergs:’ Study says 100s of Arctic glaciers shrinking, disappearing

The statistics in her recently published paper say it all: hundreds of… Continue reading

U.S. hits back with WTO challenge against Canada’s retaliatory tariffs

OTTAWA — The United States fired back Monday at the Canadian government’s… Continue reading

Croatia gears up to give heroes’ welcome to World Cup team

ZAGREB, Croatia — Fans are pouring in from throughout the country as… Continue reading

Statelessness a hurdle for some rescued Thai boy

MAE SAI, Thailand — The 12 boys and coach of the Wild… Continue reading

Lobbying commissioner rejects complaints against firearms panel member

OTTAWA — A federal watchdog has dismissed complaints that a mass-shooting survivor… Continue reading

CREA reports June home sales down 10.7% from year ago, but up from May

OTTAWA — The Canadian Real Estate Association says the number of homes… Continue reading

Red Deer Royals place second at Calgary Stampede parade

Royals depicted life in forest and portrayed destruction by human beings

Muslim candidates running in record numbers face backlash

SPRINGFIELD, Mass. — A liberal woman of colour with zero name recognition… Continue reading

Most Read


Five-day delivery plus unlimited digital access for $185 for 260 issues (must live in delivery area to qualify) Unlimited Digital Access 99 cents for the first four weeks and then only $15 per month Five-day delivery plus unlimited digital access for $15 a month