Divi's Laboratories Limited got Import Alert 66-40 issued by US-FDA on products manufactured at the company’s Unit-II at Yisakhapatnam, Andhra Pradesh
Company state that US-FDA has issued an Import Alert 66-40 on 20th March 2017 on the products manufactured at the company’s Unit-II at Visakhapatnam, Andhra Pradesh.
The Agency has exempted the following products from the Import Alert:
Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium, Raltegravir potassium. Atovaquone, Chloropurine, BOC core succinate
, 2,4-wing active ester
Import Alert 66-40 means Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.
The company has already initiated necessary measures to address the concerns raised by the US-FDA and is making all efforts to fully meet the compliance requirements.
