More manufacturing misery for GSK
pharmafile | April 4, 2014 | News story | Manufacturing and Production, Sales and Marketing | GSK, Ireland, Paxil, cork, manufacturing
GlaxoSmithKline’s manufacturing woes are getting worse after the firm was hit with a second FDA warning in as many days.
This time the problems surround batches of antidepressants Paxil and Seroxat (paroxetine) that contain ingredients manufactured at an Irish plant that the FDA says is not up to scratch.
GSK says in a statement that it is pulling 47 batches of the drug from wholesalers, but the London-based firm maintains that the potentially tainted pills pose ‘no risk’ to human health.
In the latest warning letter to GSK, the US regulator says: “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.”
The FDA blamed the company for failing to take sufficient action to clear up problems it identified during an inspection in October last year. The investigator also raised concerns about the suitability of the equipment used to manufacture the ingredients.
GSK recorded sales of £285 million ($474.11 million) for Paxil and Seroxat in 2013.
This all comes just a day after the company was told by the FDA that the US importation of products from the firm’s facility in Cork, Ireland ‘could be blocked’ – until its manufacturing problems have been addressed at the site.
The FDA went even further, saying it might withhold approval of any new drug applications that list GSK as the manufacturer of their drug ingredients, until GSK correct the issues.
And last week the firm had to recall its OTC weight-loss drug Alli (orlistat) after ingredients ‘other than the drug’ were found in bottles of Alli.
Ben Adams
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