On Wednesday I wrote how the FDA had sent GlaxoSmithKline a warning letter listing a series of violations regarding their plant in Ireland.
The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.
According to the FDA's warning letter, Glaxo became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of paroxetine manufactured using the contaminated solvents on April 19, 2013. Glaxo then distributed paroxetine shipments that were potentially contaminated.
RTE News reported on Wednesday that the Irish Medicines Board had confirmed that a number of batches of Seroxat, that were being recalled by GlaxoSmithKline, had been placed on the Irish market.
So, let's get this straight.
Glaxo knew back in 2012 that batches of paroxetine had become contaminated with material from their waste tank but they did nothing?
I'd smell a lawsuit if this were America. Sadly, European law firms don't have the financial clout to go up against the likes of GlaxoSmithKline.
Inspectors from the Irish Medicines Board are now on site "to ensure that the company's investigation into what happened has been thorough."
How reassuring. Glaxo being monitored by an agency that, in 2009, received 27.08 million euro from the pharmaceutical industry.
This must come as a huge embarrassment to Glaxo Chief, Andrew Witty, who last year blamed Glaxo's fraudulent behaviour on an 'era'. This after his company his company plead guilty to violations over a number of its drugs.
This isn't the first time the FDA have had to warn GlaxoSmithKline over contaminated products.
Back in 2010 Glaxo pleaded guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.
Here's an interview with Cheryl Eckard, a former employee of GlaxoSmithKline who was fired after raising the Cidra violations with company officials..
In the words of Jim Royle [Royle Family], "Part of an era, my arse."
Bob Fiddaman
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