THE US FOOD and Drug Administration (FDA) has issued a warning to pharmaceutical company GlaxoSmithKline over a drug ingredient manufactured at its Cork site that was contaminated from its waste tank.
In a warning letter to the firm on 18 March, the FDA said that the ingredient paroxetine, used to manufacture batches of the anti-depressant drugs Paxil and Seroxat, was contaminated “with material from your pharmaceutical waste tank, which contained APIs (active pharmaceutical ingredients), intermediates and solvents”.
The authority noted that the company became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of the ingredient manufactured using the contaminated solvents. The firm distributed shipments of potentially contaminated batches after becoming aware of “this significant deviation”. The FDA said the batches made with the contaminated ingredients were rejected.
In its letter, the FDA said personnel at the Cork plant told the investigator that the company “determined that there was no potential to impact the quality of the affected products” manufactured with paroxetine and so it “chose not to ‘escalate’ the deviation by notifying your customers”.
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 your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse.
In a statement the company said it is currently reviewing the content of the FDA letter to assess the concerns raised, saying it takes them “very seriously”.
It will submit a “comprehensive response” to FDA by 9 April 2014. The US body has asked the firm to address its concerns and explain its quality assessment decisions.
In the meantime, the firm has initiated a recall from wholesalers of certain batches of Paxil/Seroxat containing the ingredient supplied by the Cork site, that are within the scope of the letter.
“Based on a medical assessment, GSK considers that there is no increased risk of harm to patients by taking tablets manufactured from the implicated batches of paroxetine active pharmaceutical ingredient,” a spokesperson said.
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