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Manufacturing problems persist for Aurobindo, U.S.’ second-largest generics producer

When Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S. But it is one that brings a history of quality issues when it comes to manufacturing, as exemplified in the latest thrashing by the FDA.
 
The agency this week posted a Form 483 for Aurobindo’s plant in Telangana with nearly a dozen observations but one overriding issue, the agency said. The plant’s quality control unit, which should be ensuring products meet the highest standards before shipping to the U.S., doesn’t seem to know what it is doing.

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