FDA raises the concern over Wockhardt’s US unit
The US Food and Drug Administration has raised the concern over production processes at the Wockhardt’s US unit. The FDA has already banned the import of generic drugs from its two plants in India due to quality problems in the manufacturing process. United States is Wockhardt’s biggest market. The company’s spokesperson said that they had responded to the FDA’s observations but declined to give details. And if the FDA is not satisfied with the response, it could ban production from its Chicago-based Morton Grove Pharmaceuticals unit, which accounts for more than 50 percent of Wockhardt’s sales in the United States. The spokesperson also said that it’s difficult to say what kind of position the FDA will take but according to the company the inspection was not a very negative inspection.
The FDA had sent Wockhardt a “Form 483,” a letter in which the agency typically outlines the unsatisfactory results of manufacturing facilities made by its inspectors on compliance with the current good manufacturing practices (cGMP).