FDA Berates Lupin for Repeatedly Making Pills That Don't Meet Quality Standards

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Lupin Ltd., which makes generic antibiotics, antidepressants and heart medications for sale in the U.S., 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.

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