NEW DELHI, Nov 2: Drug firm Divi’s Laboratories today said the US health regulator will lift an import alert imposed on the company’s Unit-II in Visakhapatnam and is moving to close out the warning letter issued to the unit.
The company “has been informed by the United States Food and Drug Administration (USFDA) that it will be lifting the Import Alert 66-40 and move to close out the warning letter issued to the company’s Unit-II at Visakhapatnam”, Divi’s Laboratories said in a filing to BSE.
It, however, did not share any details and timelines for resolution of the matter.
Earlier in July, the company announced that USFDA had moved to lift Import Alert 99-32 imposed on the unit.
In March this year, Divi’s Labs said USFDA 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 practice (GMP) norms.
As per 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”.
(PTI)
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