IGMPI India



Britain's biggest drug maker, GlaxoSmithKline warned by US FDA to review its manufacturing practices

GlaxoSmithKline was warned by US FDA to review its manufacturing operations worldwideafter finding its Canadian subsidiary to have violated quality requirements during the production of its flu vaccine FluLaval. During the inspection of the site in Sainte-Foy, Quebec, in April FDA inspectors found that the plant had failed to take appropriate steps to prevent microbiological contamination of drug products claiming to be sterile. It was also found that controls for the purified water system at the site, which employs 600 people, were inadequate to prevent contamination.

FDA quoted in the warning letter deviations from current good manufacturing practice in the production of FluLaval at GSK's Quebec-based subsidiary ID Biomedical, which makes the vaccine for Canada and the US. FDA stated that it expects ID Biomedical and GSK to undertake a comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements. GSK’s sites in Dresden in Germany and Rixensart in Belgium, which make Fluarix, are unaffected by the warning letter.

GSK had six new medicines approved by the FDA last year, nearly a fifth of all approvals and the highest number for any drugmaker.In early June, GSK settled allegations by 44 US states and the District of Columbia going back 14 years that it promoted its big-selling drugs Advair, Paxil and Wellbutrin for unapproved uses.