The FDA recently added Wockhardt's bulk manufacturing plant in Ankleshwar, India, to its import alert list, joining plants in Waluj and Chikalthana that the FDA banned in 2013. The alert does not say why the plant's products were banned, but Wockhardt has a history of manufacturing shortcomings at other plants.
The agency followed the earlier bans up with a warning letter that criticized the drugmaker for hiding failed testing results and manipulating tests to make it appear that drug batches had met FDA standards when they hadn't. The FDA said Wockhardt employees at the Waluj plant had tried to destroy records and lied to inspectors about having giving them access to all drug manufacturing areas.
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