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, lays 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 notes that since 2011 it has rejected multiple batches of flu vaccine from the Quebec plant. It warns 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 states.
"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 used in Canada, did not immediately comment on the FDA action.
The FDA letter says the Quebec facility deviates from current good manufacturing practice requirements, the industry standards enforced by licensing agencies.
It raises concerns about the purified water system at the plant and gives 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 asks 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 says 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.