SINGAPORE--Wockhardt's chairman told reporters the company's Illinois production plant, responsible for half its sales in the United States, has taken care of the issues that led the FDA to issue it a Form 483 citing compliance failures last year.
The inspector-level complaint was made more serious for Wockhardt since two of its India plants were banned from exporting to the U.S. in 2013, making the plant in Morton Grove that much more critical.
|Wockhardt Chairman Habil Khorakiwala|
Chairman Habil Khorakiwala revealed the remediation while talking to reporters on the occasion of the release of Wockhardt's quarterly report. Wockhardt also disclosed that its board voted to extend his chairmanship for another 5 years beyond the end of March.
A series of inspections of the U.S. plant noted current good manufacturing practices violations in its production process at this time last year. The Form 483 cited a dozen procedural lapses by the generics maker, according to DNA India.
Wockhardt said it experienced a 14% increase in net profits during the final 2014 quarter, thanks to its business in the U.K. where regulators cleared its India facility to resume producing drugs following CGMP issues.
- here's the DNA India piece