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USFDA lifts import alert on Divi's Labs' Vishakhapatnam unit

Press Trust of India/New Delhi 15 Nov 17 | 12:45 PM

Drug firm Divi's Laboratories today said the US health regulator has lifted import alert imposed on its unit at Visakhapatnam.

Last week, the company in a regulatory filing had said the US Food and Drug Administration (USFDA) had "closed out" a warning letter issued to the unit in Visakhapatnam following evaluation of corrective actions taken by the company at the plant.

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"The FDA's website has now been updated on November 14, 2017, and the import alert 66-40 on the company's unit-II has been removed," the company said in a BSE filing.

The USFDA in March had issued import alert under clauses 99-32 and 66-40 and a warning letter later for the Visakhapatnam facility for non-compliance of good manufacturing practices (GMP) norms, the company had informed bourses earlier.

The company in July announced that the USFDA had moved to lift Import Alert 99-32 imposed on the unit. As per the USFDA, an import alert under 66-40 entails "detention without physical examination" of drugs from firms which have not met drug GMPs while alert under 99-32 is issued to "firms refusing FDA foreign establishment inspection".

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