USFDA adds one more clause to import alert on Divi's Labs

Charges firm with 'refusal for inspection', indicating possible unhygienic manufacturing processes

The US Food and Drug Administration (USFDA) has invoked one more clause in connection with the import alert issued to Unit-2 of Hyderabad-based Divi's Laboratories Limited, this time charging the company with 'refusal for inspection'.

The import alert was first issued under clause 66-40, which authorises detention without physical examination of drugs from firms that have not met drug GMPs (good manufacturing practices).

Further, the US drug regulator has added clause 99-32, which authorises similar action for products from firms refusing 'FDA foreign establishment inspection.'

While admitting the development in a disclosure to the Bombay Stock Exchange (BSE) on Wednesday, the company