(Adds company statement)
By Vrinda Manocha
April 1 (Reuters) - The U.S. Food and Drug Administrationfound that a drug ingredient manufactured at a GlaxoSmithKlinePlc plant in Ireland was contaminated and said thecompany did not take sufficient action to resolve the problems.
GSK said the ingredient was paroxetine, used to make itsantidepressant drugs Paxil and Seroxat.
The company said it had proposed a recall of certain batchesof the drugs from wholesalers but there was no risk of harm topatients taking these drugs.
In a warning letter dated March 18, the FDA said GSK did notfully investigate a list of objectionable conditions theregulator sent after its inspection of the plant at Cork inOctober.
Some batches of a drug or drugs using the contaminatedingredient were later shipped, the FDA said, and GSK did notnotify its customers about the lapse.
The FDA said its investigator found that a certain drugingredient was contaminated with material from the plant'spharmaceutical waste tank. (http://link.reuters.com/xah28v)
The FDA said it might withhold approval of any new drugapplications that list GSK as the manufacturer of their drugingredients until GSK corrected the issues.
The regulator said it also might refuse the import of drugsmanufactured at the Cork facility into the United States.
The Cork plant is the company's only drug ingredientmanufacturing facility in Ireland.
"Cork is the main site for manufacturing the API(paroxetine), we do buy in some from a third party, but Cork isthe main site where we produce it," a company spokesman toldReuters.
Over-the-counter medicines and oral care products aremanufactured at a plant in Dungarvan, while consumer productsare made at Sligo, both in Ireland.
GSK recorded sales of 285 million pounds ($474.11 million)for Paxil and Seroxat in 2013, the spokesman said.
The investigator also raised concerns about the suitabilityof the equipment used to manufacture the ingredients.
The news comes just days after GSK said it was recalling allsupplies of its over-the-counter weight-loss drug in the UnitedStates and Puerto Rico, after concerns that bottles had beentampered with.
The FDA has stepped up its efforts to ensure drug safety inrecent months, banning drugs and drug ingredients imported fromIndian manufacturers over quality concerns.
Ranbaxy Laboratories Ltd has been banned fromexporting drugs from its Indian plants to the United States. Oneof Sun Pharmaceutical Industries Ltd's plants and someof Wockhardt Ltd's plants have also been barred fromexporting to the United States. ($1 = 0.6011 British Pounds) (Reporting by Vrinda Manocha in Bangalore; Editing by MajuSamuel and Don Sebastian)