(Corrects last paragraph to say that one Sun Pharma plant andsome Wockhardt plants have been barred from exporting drugs tothe US. The incorrect version suggested that all Sun Pharma andWockhardt plants were barred)
April 1 (Reuters) - The U.S. Food and Drug Administrationfound contamination of drug ingredients manufactured at aGlaxoSmithKline Plc plant in Ireland and said thecompany did not take sufficient action to resolve the problems.
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.
In a warning letter dated March 18, the U.S. FDA said GSKdid not fully investigate a list of objectional conditions theregulator sent after its inspection of the manufacturing plantat Cork, Ireland in October.
The FDA said its investigator found that a certain drugingredient, the name of which was not disclosed, wascontaminated with material from the plant's pharmaceutical wastetank. (http://link.reuters.com/xah28v)
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 investigator also raised concerns about the suitabilityof the equipment used to manufacture the ingredients.
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.
GSK was not immediately available for comment.
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. (Reporting by Vrinda Manocha in Bangalore; Editing by MajuSamuel)