For the third time in four months, Lupin Pharmaceuticals, one of India’s biggest suppliers of generic drugs to foreign markets, has been admonished by the Food and Drug Administration for a series of troubling quality-control issues at a manufacturing facility.
In a recent inspection report, the regulator cited the company for failing to thoroughly review unexplained deficiencies in batches of medicines and not taking “scientifically sound” steps to evaluate samples; delays in assessing health hazards; insufficiently investigating customer complaints, including an instance involving mold on medicines shipped to the U.S.; and a lack of oversight and training.
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