By Dow Jones Business News,
June 24, 2014, 09:45:00 PM EDT
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
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