US FDA warns Indian drugmaker Lupin on repeated quality violations

Washington

LUPIN Ltd, which makes generic antibiotics, antidepressants and heart medications for sale in the United States, was warned by the Food and Drug Administration (FDA) for repeatedly ignoring tests showing that pills made at two of its facilities didn't meet quality standards.

In 2015 and 2016, the FDA found 134 instances when drugs or active ingredients failed initial testing but the company chose to override the results. Lupin called the failed tests at the plant "laboratory error" even when evidence suggested that wasn't the case.