FDA Blackballs Sun Pharma Plant In Import Safety Crackdown

Law360, New York (March 13, 2014, 4:00 PM EDT) -- The U.S. Food and Drug Administration on Wednesday continued a parade of enforcement actions targeting Indian drugmakers’ quality control, blocking imports from a Sun Pharmaceutical Industries Ltd. plant found to be noncompliant with U.S. safe-manufacturing standards.

The Mumbai-based generic drug manufacturer’s Karkhadi facility, in the state of Gujarat on India’s northwest coast, was placed on import alert for unspecified violations of current good-manufacturing standards, compelling U.S. customs agents to seize shipments originating there until the FDA says otherwise. The plant makes cephalosporins, a class of powerful...
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