US FDA Warns Lupin Again About Poor Batch Failure Investigations
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
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Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.
Lupin says it is rebuilding its reputation for quality and compliance after the US FDA awarded VAI status to a manufacturing facility in Goa that was hit by a warning letter back in 2017.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.