Aurobindo Receives Warning Letter After Form 483

The US Food and Drug Administration has issued Aurobindo with a warning letter for an API site, shortly after one of its formulations plants received yet another Form 483, with ten observations.

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Aurobindo has been hit with a warning letter for an API site and a Form 483 for a formulations plant • Source: Shutterstock

Aurobindo has suffered another compliance blow after receiving a US Food and Drug Administration warning letter for one of its Indian active pharmaceutical ingredient facilities, hot on the heels of its third Form 483 in the span of the last four months for a separate Indian formulations plant.

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