(Corrects last paragraph to say that one Sun Pharma plant and
some Wockhardt plants have been barred from exporting drugs to
the US. The incorrect version suggested that all Sun Pharma and
Wockhardt plants were barred)
April 1 The U.S. Food and Drug Administration
found contamination of drug ingredients manufactured at a
GlaxoSmithKline Plc plant in Ireland and said the
company did not take sufficient action to resolve the problems.
The news comes just days after GSK said it was recalling all
supplies of its over-the-counter weight-loss drug in the United
States and Puerto Rico, after concerns that bottles had been
In a warning letter dated March 18, the U.S. FDA said GSK
did not fully investigate a list of objectional conditions the
regulator sent after its inspection of the manufacturing plant
at Cork, Ireland in October.
The FDA said its investigator found that a certain drug
ingredient, the name of which was not disclosed, was
contaminated with material from the plant's pharmaceutical waste
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 investigator also raised concerns about the suitability
of the equipment used to manufacture the ingredients.
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.
The regulator said it also might refuse the import of drugs
manufactured 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 in
recent months, banning drugs and drug ingredients imported from
Indian manufacturers over quality concerns.
Ranbaxy Laboratories Ltd has been banned from
exporting drugs from its Indian plants to the United States. One
of Sun Pharmaceutical Industries Ltd's plants and some
of Wockhardt Ltd's plants have also been barred from
exporting to the United States.
(Reporting by Vrinda Manocha in Bangalore; Editing by Maju