On FDA demand, Wockhardt revamps quality control team

“Our entire quality team is new,” Khorakiwala said, adding that none of the people who had handled quality operations in the past was at the helm, as that was what the US regulator wanted. Wockhardt’s Chikalthana and Waluj plants in Maharashtra are currently banned from selling their products in the US. Khorakiwala was speaking to the media on Thursday, following the latest inspection of its Chikalthana plant, Aurangabad, by the USFDA.

This was a follow-up of the inspection of Wockhardt’s remedial measures late last year, he said.

On the fresh observations on the 483 form — where preliminary notes are recorded by the regulator — he clarified that it had to do with products manufactured before its GMP (good manufacturing practices) initiatives were implemented.

On Wednesday, Wockhardt told the stock exchange that its efforts at data control in laboratory and manufacturing were appreciated and there were no regulatory findings from the USFDA.

Khorakiwala further said that the company had created a global quality system with offices in India, the US and UK, besides training quality operations staff (whose numbers have been increased) and installing IT infrastructure. The company’s Kadaiya plant in Nani Daman continues in full compliance of the UK regulator’s requirements, he said, referring to earlier troubles. Incidentally, the Chikalthana facility, which also faced some rough weather in the UK, has since been cleared.

Gradual recovery
Meanwhile, on its Shendra site, he said, it continues to file applications for approval to sell in the US.

Though Khorakiwala did not give a timeline to resolving the problem, he hoped it would be resolved “in the near future”. Wockhardt’s stock spiked on the development, closing up about 2 per cent at ₹1,909 on Thursday.BusinessLine