FDA slams GSK for manufacturing oversights
pharmafile | April 3, 2014 | News story | Manufacturing and Production | FDA, GMP, GSK, Ireland, cork, mage, manufacturing
The FDA has warned GlaxoSmithKline that the US importation of products from the firm’s facility in Cork, Ireland could be blocked until manufacturing problems have been addressed at the site.
In a warning letter dated 18 March, the US regulator outlined a number of deviations from good manufacturing practice (GMP) guidelines identified during an inspection of the plant in October 2013.
These include: contamination of products by waste materials; conscious distribution of potentially adulterated drug batches; inadequate completion of quality impact assessments, and failure to communicate potential contamination to consumers.
As Reuters reports, GSK has confirmed that the problems relate to the drug ingredient paroxetine, which is used to produce branded antidepressants Paxil and Seroxat.
The British firm said that it did not consider the contaminated batches to pose a risk to public safety. The FDA, however, does not share that viewpoint, stating: “We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact.”
In addition to the potential US ban on products originating from the Cork site, the letter warns: “Until all corrections have been completed…FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer.”
The FDA has issued a number of high-profile warnings to Indian manufacturers Ranbaxy and Wockhardt in recent months, with both firms facing product bans in the US.
As developments in GSK’s Cork facility suggest, though, such production issues are not confined to developing world industries – and even the biggest players cannot afford to be complacent.
The news comes during a bad week for the UK’s largest pharma firm which has also terminated a late-stage trial of its MAGE-A3 lung cancer vaccine, and follows the release of disappointing clinical results for the treatment.
Hugh McCafferty
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