FDA warns Indian pharma Lupin on quality violations

Bloomberg

Lupin Ltd., which makes generic antibiotics, antidepressants and heart medications for sale in the US, was warned by the Food and Drug Administration 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.
At another Lupin plant, the company deemed failed quality tests outliers, and retested the samples to get a passing result.
In a warning letter to Lupin, the FDA called the issues “significant violations”. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” FDA staff wrote. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately,
the products manufactured, conform to FDA requirements at all your sites.”
India and China make a large share of the drugs and drug ingredients used by US patients.