Drugmaker Wockhardt has initiated remedial action at its Aurangabad site, after the US Food and Drug Administration inspected the site and made certain observations.
“We have initiated urgently, an accelerated and a comprehensive remedial measure of the USFDA observations. We have already given full and comprehensive response to FDA. We are determined to achieve full compliance in the shortest time,” Wockhardt said, adding that it was committed to following quality good manufacturing practice (GMP) norms, outlined for drug companies.
The FDA inspected Wockhardt’s export-oriented injectable units in Aurangabad and the regulator issued “483s”, the company said.
Explaining observations made on a 483 form, a regulatory affairs expert said, that a company is let off the hook if it took preventive measures on these observations. But if concerns persist over safety, efficacy and quality of the drugs coming into the US from the suspect manufacturing unit, then a warning letter is issued, he added.
“They (483s) are inspectional observations, to document and communicate concerns discovered during the audit, and do not represent a final agency determination regarding the compliance of the facility,” said a report from Macquarie Capital Securities India.
“To put things in perspective, the FDA issued 40 drug GMP Warning Letters in 2012 against more than 10,000 483s last year,” the report added.
The track-record of Wockhardt is impressive, the analyst report said, with no product recall or warning letter till date. “483s have been currently raised for the injectable block at the EoU Aurangabad facility. Oral block in the facility has no observations,” it added.
Another veteran pharma analyst observed that exports from the company would continue, if the USFDA accepted the measures taken by Wockhardt. Else, it would be followed by a warning letter and import alert.
On Wednesday, Wockhardt shares closed at Rs 1,797, up six per cent, on the BSE.