The Food and Drug Administration has uncovered quality control problems at a Canadian GlaxoSmithKline plant that manufactures the flu vaccine FluLaval. The FDA has ordered the British pharmaceutical company to review its manufacturing processes worldwide.
On June 12 the FDA sent a warning letter to the facility in Sainte-Foy, Quebec, operated by GSK subsidiary, ID Biomedical. The letter said the company is not taking the necessary steps to prevent microbial contamination and that controls for the purified water system are inadequate.
The plant manufactures flu vaccines for the United States and Canada, but GSK said no contaminated products have been distributed to the public.
The FDA said Gram-negative bacteria found in water used to wash equipment started causing product contamination issues at the facility in 2011. That year 24 vaccine lots were rejected because of too many endotoxins, which exist in Gram-negative bacteria and can cause health problems.
Vaccine lots made at the plant were also rejected in 2012, and last year some test lots turned out to be contaminated. This year 21 percent of the lots showed bacteria growth and the presence of endotoxins.
GSK said it is committed to working with the FDA to fully resolve all of the issues. Company officials said every vaccine batch is rigorously tested and is discarded if it does not pass the review.
GSK plans to provide 28 to 33 million vaccine doses to the U.S. for the upcoming flu season. The company usually starts shipping the vaccines in late July and does not expect a delay.