The U.S. Food and Drug Administration (USFDA) has issued an import alert on products manufactured at Divi’s Laboratories Ltd.’s Unit-II at Visakhapatnam for not meeting good manufacturing practices (GMPs).
The Import Alert 66-40 was issued on March 20, the company said in a filing to the stock exchange on Tuesday. It gave a list of 10 products that had been exempted from the Import Alert. The news sent the company’s shares plunging 19.77% to ₹634.35 on the BSE.
Import Alert 66-40 is one leading to detention without physical examination of drugs from firms which had not met Drug GMPs. “Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current GMPs,” the regulator said.
Divi’s Laboratories, in the filing, said it was working in association with third party consultants to address the concerns of USFDA and “making all efforts to fully meet the compliance requirements. The Unit-II at Visakhapatnam was inspected by the regulator from November 29 to December 6 last year and the company was issued a Form 483 with five observations. “These shall be responded within the time permitted,” the company had said then.
