Divi's Labs' Vizag unit gets warning letter from USFDA

Company doesn't disclose contents of alert, which follows issue of Form 483 with five observations

Divi's Laboratories has informed the stock exchanges that the US drug regulator has issued a warning letter for its unit-II at Visakhapatnam, Andhra Pradesh.

"We will respond to this warning letter with a detailed plan within the stipulated time," the company said in a statement on Saturday, without disclosing the details of the warning letter.

Divi's Laboratories, along with external consultants and subject matter experts, is working to address the concerns of the US Food and Drug Administration (USFDA) and is making all efforts to fully meet the compliance requirements, it said.

The US FDA had earlier had issued form 483 with five observations after inspecting the Visakhapatnam unit between November 29, 2016 and December 6, 2016.

Divi's has responded to the observations with an appropriate remediation process to overcome the deficiencies observed, and also provided periodic updates to the agency.

However, the regulator has issued an import alert on March 20 on the products manufactured at this facility under two clauses, 66-40 and 99-32 of the FDA regulations.

Later, USFDA exempted 10 products from the import alert including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC core succinate and 2, 4-wing active ester.

The company will continue to supply these active ingredients from the Visakhapatnam unit to meet its obligations to the customers, Divi's said.