Wockhardt Told by U.S. FDA to Evaluate Its Drug Plants

Wockhardt Ltd., the Indian drugmaker banned from selling some medicines to the U.S. from two of its factories this year, is being told by regulators to conduct a global assessment of its entire manufacturing process.

The U.S. Food and Drug Administration is questioning the reliability and accuracy of tests used to ensure product stability following its decision last week to ban some drugs from the Mumbai-based company. Wockhardt’s inability to test for quality “raises concerns about the integrity of all data generated by your firm,” according to an FDA warning letter made public today that Wockhardt said last week it received.