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
Subscribe to WSJ: http://online.wsj.com?mod=djnwires