The U.S. FDA has issued a warning letter to Mumbai-based Wockhardt for its Morton Grove facility in Illinois.
The warning letter, issued on February 17, concerns inspection a year ago at a Wockhardt subsidiary Morton Grove drug manufacturing plant. This is the second warning letter the drugmaker has received this calendar year, with the first regarding an inspection of a plant in Mumbai.
The most recent letter summarizes significant cGMP violations, including data integrity issues and failing to test in-process materials during production. It also says that Wockhardt has failed to thoroughly investigate any unexplained failure of products or components to meet specifications.
The FDA has decided to withhold approval of pending drug applications from Wockhardt's Morton Grove facility, until the company corrects the violations.
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