GSK ordered to review manufacturing by FDA

Posted on 25 Jun 2014 by The Manufacturer

GlaxoSmithKline, the UK’s biggest pharmaceutical company, has been ordered to review its global manufacturing operations after it was discovered a Canadian subsidiary failed to meet quality requirements during production of a flu vaccine.

The production of FluLaval by Quebec-based ID Biomedical, which helped make £150m for GSK last year after 26m global sales, is under review from America’s Food and Drug Administration.

Citing “deviations from current good manufacturing practice, the news is a further blow to the company following a string of incidents which have included corruption allegations across a number of countries, which included the firm paying out $63m in the USA as a settlement.

After an inspection at the Quebec site last April, the FDA discovered the facility had failed to ensure the prevention microbiological contamination of drug products purporting to be sterile, while also finding inadequate contamination prevention in its purified water systems.

GSK has confirmed it is now working with the FDA to resolve the issues, and said in a statement: “We are committed to working with the agency to fully resolve all outstanding issues.”

“Patient safety is our first priority and we are confident in the safety of the influenza vaccines we have provided to patients. Every batch of GSK vaccines is subject to extensive review before it is released. Vaccines that do not pass this rigorous review are discarded.”