cGMPs

Fresh Concerns over Wockhardt's Banned Plant

Feb 26, 2015

Wockhardt has reported that the U.S. FDA has raised new concerns about its Waluj plant, which is already banned from exporting to the United States over quality issues.

FDA concerns came after a after a week-long inspection of Wockhardt's Waluj manufacturing plant in central India.

The Economic Times reports that the FDA made seven observations, some of which serious in nature, related to quality control, quality assurance, documentation and infrastructure. At least one observation is a repeat from a 2013 inspection.

However, according to a CNBC interview with Wockhardt CEO Habil F Khorakiwala, "Generally observations by U.S. FDA do reflect some of these areas [quality control, quality assurance] but the question is are they minor and they are correctable? So, there were no serious or critical observations by U.S. FDA."

FDA has banned imports from the Waluj plant, as well as the company’s main Chikalthana plant in Aurangabad, since 2013 over concerns related to manufacturing practices.