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Enforcement Updates in Brief

Pan Drugs told FDA it would divert dirty plant’s API to India; Zhejiang Hisun reels from import alert, warning letter; Impax resolves warning letter; Polydrug and Akorn put on import alert; and TxCell outsources GMP problems away.

FDA issued a warning letter on Sept. 2 to step up the pressure on Pan Drugs Ltd. to upgrade an active pharmaceutical ingredient manufacturing facility in the Nandesari Industrial Estate near Vadodara in India’s state of Gujarat that hadn’t gotten around to keeping out the pigeons.

As for API batches made under conditions there that FDA found unacceptable, the company said not to worry, it would just divert them to the domestic market.

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