The US Food and Drug Administration (USFDA) has banned Wockhardt from importing drugs into the US and put it on notice for “significant violations” at its manufacturing facility in Waluj, Maharashtra. The UK drug regulator has banned Wockhardt from exporting to Europe for the same reason.
“These ‘violations’ rendered drugs from this facility adulterated,” the FDA said in a warning letter addressed to Wockhardt chairman Habil Khorakiwala last week.
The contents of the letter became public when USFDA put it up on its website. Following this, Wockhardt share crashed Rs 165.20 or 20% on Wednesday to Rs 661.
The US investigators identified “significant violations of current good manufacturing practice” regulations for finished pharmaceuticals, the letter said and documented that your firm withheld truthful information and delayed and limited the inspection”.
It has given Wockhardt 15 days to respond, it added. The Wockhardt management has initiated the process of correcting the violations outlined by USFDA and has appointed a leading US consultant for this purpose.
“The consultant has extensive experience and expertise in current good manufacturing practices and will work with the Wockhardt team to address issues raised by USFDA,” said Murtaza Khorakiwala, managing director,
Wockhardt, in an emailed response to an HT questionnaire. The letter warned Wockhardt that failure to take corrective action, which has to be verified by US authorities, may result in the “FDA continuing to refuse admission of articles manufactured” at the Waluj facility.