09 July 2013 | Regulatory | By BioSpectrum Bureau
Wockhardt is issued second import alert for manufacturing related lapses at its Waluj manufacturing facility in India
Singapore: About two months after the US Food and Drug Administration (US FDA) issued a Form 483 to Wockhardt for drug quality issues, the company has run into trouble with UK's Medicines and Healthcare Products Regulatory Agency (MHRA) now.
MHRA has issued an import alert on a unit of Wockhardt's plant at Waluj, Maharastra, restricting imports from the Indian plant. This move comes only six weeks after the FDA banned products from the facility from being shipped to the US.
Wockhardt has announced that the import alert from MHRA has reached them and the company's chairman Mr Habil Khorakiwala said that it would shift manufacturing from the Waluj plant to another facility to minimize the financial fallout.
In May, the US FDA had put the plant on its watch list and the company had then acknowledged that the US alert would cost it upto $100 million. The US FDA had in April issued a Form 483 to the company after observing problems at the company's solid-dose and sterile-injectables plant.
Wockhardt had initiated 'an accelerated and comprehensive remedial measure' and had said that it was committed to achieving full compliance in the shortest period of time.