A third Wockhardt Ltd. drug-manufacturing plant in India has been banned by the Food and Drug Administration from importing products into the U.S., the agency said Aug. 5.
The FDA said in an alert posted online that it had banned all drugs and drug products made by the factory. The plant, based in Ankleshwar, India, makes bulk ingredients, according to Wockhardt’s annual report. The agency recently inspected the Ankleshwar facility and three others, the company said in the report, and Wockhardt had responded to those findings.
Details of the FDA’s observations haven’t been made public, and Lyndsay Meyer, a spokeswoman for the ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.