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Manufacturing Quality Enforcement

US FDA Warns Lupin Again About Poor Batch Failure Investigations

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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