The U.S. Food and Drug Administration has warned GlaxoSmithKline Plc that one of its plants in Canada violated quality control standards during the manufacture of its influenza vaccine Flulaval.
In a warning letter dated June 12, the FDA said the company had failed to take appropriate steps to prevent microbiological contamination of drugs, among other violations.
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The FDA also said controls for the purified water system at the Quebec City plant were inadequate to prevent contamination. (http://1.usa.gov/1jL3UUS).
GSK said in a statement on Tuesday that it is "committed to working with the agency to fully resolve all outstanding issues."
"Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients," the company said. "Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded."