US FDA observations for Shendra facility not critical: Wockhardt

According to the company, half of the issues will be resolved in next fortnight

The nine observations received by Wockhardt for its Shendra facility in Aurangabad from the US health regulator are not ‘critical’ in nature and half of the issues would be resolved in next fortnight, the company said on Monday.

“None of the nine observations that we have received are of critical nature. We would be able to make the facility compliant for half the issues in next fifteen days and rest would be resolved in two months or so,” Habil Khorakiwala, Chairman, Wockhardt.

He added that none of the observations by the US Food and Drug Administration (US FDA) were related to data integrity issues at the Shendra plant.

The facility, which produces various products including ointments, capsules and tablets, currently caters to the UK and Ireland markets.

“Other than the US market which is affected, our other businesses like India, the UK and emerging markets remain strong. We have been growing 20 per cent and above year-on-year in these markets and hope to maintain that in future too,” Khorakiwala said.

He added that the company is having an intense dialogue with the US FDA on resolving compliance issues at its various facilities like Waluj and Chikalthana in Maharashtra.

“I believe issues at some of the facilities will get resolved in next few months,” Khorakiwala said.

The company’s Waluj and Chikalthana plants are already under the US FDA scanner and the company cannot export most products from these two plants to the US market.

The company is now relying on third party manufacturing, besides some products that it is allowed to ship, to cater to the US market.

The USFDA has made nine ‘observations’ highlighting violations of its norms at Shendra plant.

The observations were made in Form 483, which is issued to a company management at the conclusion of an inspection, highlighting any conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related laws.

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