Drugmaker, FDA Agree On Terms To Fix Production Issues

Law360, New York (January 23, 2013, 3:50 PM EST) -- Ben Venue Laboratories Inc. and federal regulators on Tuesday struck a deal in which the company agreed not to resume full drug manufacturing operations at its Ohio plant until proving it has completely fixed problems that led to the plant's voluntary shutdown in November 2011.

According to a consent decree filed in Ohio federal court, Ben Venue won't be allowed to completely restore its manufacturing and distribution operations at its Bedford, Ohio, plant until an independent inspector and the U.S. Food and Drug Administration certify that...
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