GSK Flu Vaccine Plant Receives Warning Letter from FDA

According to a Reuters article, a GlaxoSmithKline plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards. The FDA said controls for the purified water system at the plant were inadequate and that some Gram-negative bacteria identified in water used for equipment washing had been implicated in product contamination issues at the facility as far back as 2011.

GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July. GSK said on Tuesday no contaminated products had been released to the public. Read the Reuters story

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