FDA Warns GSK Over Flu Vaccine Contamination

Law360, New York (June 24, 2014, 2:48 PM EDT) -- GlaxoSmithKline PLC failed to take appropriate steps to prevent bacterial contamination of its widely used flu vaccine Flulaval, causing many product batches to become tainted, according to a U.S. Food and Drug Administration warning letter released Tuesday.

The FDA’s letter, which stems from inspections in March and April, describes quality control processes at a GSK plant in Canada that had several loopholes and were applied inconsistently, resulting in microbial contamination that forced drug lots to be discarded.

For example, GSK did not have comprehensive written policies to prevent contamination of purportedly sterile products, and to the extent that policies were in...

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