GSK ordered by U.S. FDA to review its global manufacturing practices

Nathan Andrada – Fourth Estate Cooperative Contributor

London, England, United Kingdom (4E) – GlaxoSmithKline PLC was ordered by the U.S. Food and Drug Administration (FDA) to review its global manufacturing operations after its Canadian subsidiary was found to have violated quality requirements during the production of its flu vaccine FluLaval, according to a report by British newspaper The Guardian posted on its website on Wednesday.

The report said that the order is another big blow to UK’s largest drugmaker, already faced with allegations of corruption overseas in China, Jordan, Lebanon, Iraq and Poland. The company is also facing a criminal investigation at home about its sales practices with the Serious Fraud Office, according to The Guardian.

The company recently agreed to pay 63mn British pounds ($107mn) to settle allegations about its marketing in the U.S., the report said. Earlier this week, GSK offered an apology for its marketing firm’s pitch to recruit unpaid interns for its UK clinical trials, according to the newspaper.

The FDA warned the British firm for its “deviations from current good manufacturing practice” in FluLaval’s production at ID Biomedical, a Quebec-based subsidiary of GSK that makes the vaccine for the U.S. and Canada, the Guardian report said.

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