The US Food and Drug Administration (US FDA) found that a drug ingredient manufactured at a GlaxoSmithKline plant in Ireland was contaminated and said the company did not take sufficient action to resolve the problems. GSK said the ingredient was paroxetine, used to make its antidepressant drugs Paxil and Seroxat.
The company said it had proposed a recall of certain batches of the drugs from wholesalers but there was no risk of harm to patients taking these drugs.
In a warning letter dated March 18, the US FDA said GSK did not fully investigate a list of objectionable conditions the regulator sent after its inspection of the plant at Cork in October. Some batches of a drug or drugs using the contaminated ingredient were later shipped, the FDA said, and GSK did not notify its customers about the lapse.
The FDA said its investigator found that a certain drug ingredient was contaminated with material from the plant’s pharmaceutical waste tank. The FDA said it might withhold approval of any new drug applications that list GSK as the manufacturer of their drug ingredients until GSK corrected the issues.
According to a report in Reuters, the regulator said it also might refuse the import of drugs manufactured at the Cork facility into the US. The Cork plant is the company’s only drug ingredient manufacturing facility in Ireland. Over-the-counter medicines and oral care products are manufactured at a plant in Dungarvan, while consumer products are made at Sligo, both in Ireland.
The investigator also raised concerns about the suitability of the equipment used to manufacture the ingredients.
EP News Bureau – Mumbai
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