STAT+: What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history
The FDA has found that a Sun Pharmaceuticals facility in India failed to comply with a legal mandate to correct serious shortcomings.
In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the Food and Drug Administration decided that a Sun Pharmaceuticals facility failed to comply with a legal mandate to correct serious shortcomings. As a result, the company has halted exports from the plant to the United States.
At issue is a facility Sun bought eight years ago from Ranbaxy Laboratories, which was a poster child for lax manufacturing standards in India. In 2012, Ranbaxy paid a $350 million fine to U.S. authorities as part of a settlement that saw the company plead guilty to charges of violating drug safety laws, including by falsifying manufacturing data. The company also paid $150 million to settle civil claims.
What's Your Reaction?
