FDA Orders GSK to Review Its Global Manufacturing

By Dow Jones Business News, 
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The U.S. Food and Drug Administration has ordered GlaxoSmithKline PLC (GSK, GSK.LN) to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval, U.K. newspaper The Guardian reported Wednesday on its website.

The newspaper said the order presented another serious blow to Britain's biggest drugmaker, already reeling from corruption allegations in Poland, Iraq, Jordan, Lebanon and China, and facing a criminal investigation by the U.K.'s Serious Fraud Office into its sales practices, The Guardian said.

It also recently paid out GBP63 million ($107 million) to settle U.S. marketing allegations, The Guardian reported. Earlier this week GSK had to apologize for the pitch adopted by a marketing firm working for GSK to recruit unpaid interns for clinical trials in the U.K., The Guardian said.

In a warning letter to the British company, the FDA cited "deviations from current good manufacturing practice" in the manufacture of FluLaval at GSK's Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the U.S., The Guardian said.

The U.S. watchdog said when it inspected the site in Sainte-Foy, Quebec, in April it found that the plant had failed to take appropriate steps to prevent microbiological contamination of drug products purporting to be sterile, The Guardian said. It also found that controls for the purified water system at the site, which employs 600 people, were inadequate to prevent contamination, The Guardian said.

--Newspaper website: www.guardian.co.uk

Write to: Dennis.Baker@wsj.com

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