FDA Ends Ban Of Claris Lifesciences Products

Law360, Washington (August 20, 2012, 7:30 PM EDT) -- Claris Lifesciences Ltd. has received word from the U.S. Food and Drug Administration that it has adequately cleared up injectable-drug contamination issues and factory violations that resulted in a 2010 warning letter and import ban, the company announced Thursday.

In a closeout letter posted on the FDA website, the agency noted the Indian sterile-injectable maker had made the necessary changes to resolve the issues noted in its November 2010 warning letter, which said Claris' factory in Ahmedabad, India, took a lax attitude to safety that allowed...
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