FDA finds contaminated drug ingredient at GSK Ireland plant

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FDA finds contaminated drug ingredient at GSK Ireland plant

The U.S. Food and Drug Administration found that a drug ingredient manufactured at a GlaxoSmithKline Plc 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. In a warning letter dated March 18, the 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.

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