Wockhardt gets US FDA report with 'observations'

Drug firm Wockhardt on Thursday said the US health regulator, the Food and Drug Administration (US FDA), has made “observations” in its Establishment Inspection Report (EIR) for the company’s three units in Maharashtra and ban on exports from these facilities to the US will continue.

The facilities are at Chikalthana and two units at Waluj in Maharashtra.

“However, receipt of EIR does not change our existing status for the units. Receipts of EIR does not materially change the status of import alert for these manufacturing units for the US market,” the Mumbai-based company added.

An EIR is given to an establishment after completion of the inspection by FDA. The company’s Waluj plant was hit by an import alert by FDA in 2013 for not meeting manufacturing norms. The facility produces injectables, as well as solid dosages.
 

The Chikalthana facility was also put under an import alert by the  FDA on the issue of non-compliance of manufacturing norms.

Wockhardt shares were trading at Rs 991.15 per scrip, down 4.5 per cent from the previous close on the BSE.