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USFDA lifts import alert on Divis Labs Vizag unit

USFDA lifts import alert on Divis Labs Vizag unit

New Delhi: Drug firm Divis Laboratories on Wednesday 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.

“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“.

Source: PTI
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