US FDA finds Wockhardt hid failed tests

January 29, 2016 00:41

Drugmaker Wockhardt hid the results of failed tests and deleted data from its systems at a plant in western India, according to a report by the US Food and Drug Administration sent to the company earlier this month and seen by Reuters.

Issues around "data integrity", maintaining accurate and consistent databases, are key to the US watchdog, which regulates the world's largest market for generics producers.

Wockhardt is the latest of several major players in the $15 billion Indian drugs industry to be hit by US regulatory action over the past few months.

It makes around a fifth of its $670 million in annual revenues from the United States and had said the Shendra plant, the site that prompted the FDA report, would boost its US business.

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