USFDA withdraws warning letter to Divi’s Lab unit

NEW DELHI, Nov 10: Drug firm Divi’s Laboratories today said the US health regulator has “closed out” a warning letter issued to a unit at Visakhapatnam following evaluation of corrective actions taken by the company at the plant.
“Divi’s Laboratories has been informed by the USFDA that the agency has completed evaluation of the company’s corrective actions in response to FDA’s warning letter..Dated April 13, 2017” the company said in a BSE filing.
“We also note from the update on FDA’s website that they have closed-out the warning letter,” it added.
Following the announcement, shares of the company rose by 2.80 per cent to Rs 1,038 apiece in morning session on BSE.
Last week, Divi’s Laboratories had informed that the US health regulator would lift an import alert imposed on the company’s Unit-II in Visakhapatnam and was moving to close out the warning letter issued to the unit.
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 practice (GMP) norms, the company had informed bourses earlier.
The company in July announced that USFDA had moved to lift Import Alert 99-32 imposed on the unit.
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)