USFDA issues warning letter to Divis Vizag plant

Hyderabad: City-based pharma player Divi’s Laboratories on Saturday said that the US Food and Drugs Administration (USFDA) had issued a warning letter for its Unit-II at Visakhapatnam.

While the company did not divulge the details of the warning letter, it informed the bourses that it was working with external consultants and subject matter experts to address the concerns of the USFDA and was making all efforts to fully meet the compliance requirements.

“We will respond to this warning letter with a detailed plan within the stipulated time,” the company said. Divi's Labs' Unit-II in Vizag mainly manufactures active pharmaceutical ingredients (APIs) and intermediates for generics. Divis said it had responded to USFDA inspection observations with an appropriate remediation process to overcome the deficiencies observed. “As part of our commitments, we have also provided periodic updates to the USFDA,” the company added.

Divi’s Labs said that in the import alert issued earlier (in March this year) the USFDA had exempted several products manufactured at the same unit and that the company would continue to supply these active ingredients to meet its obligations to customers. On March 22, Divis Laboratories had informed the stock exchanges that USFDA had issued an import alert for products made at Unit-II in Visakhapatnam citing violation of manufacturing norms and refusal of inspection but had exempted 10 products namely -- Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen Sodium, Raltegravir Potassium, Atovaquone, Chloropurine, BOC Core Succinate and 2,4-Wing Active Ester.