Updated on 19 September 2013
Neither Ranbaxy, nor its Japanese owner Daiichi Sankyo have made a statement about the recent FDA document. Ranbaxy had, however, said that, "We will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest."
Another core observation made by the US FDA was the lack of hygiene in the toilet complexes at the manufacturing unit. "During the course of the inspection, the toilet facility adjoining change room of the raw material storage area did not have running water for hand washing and toilet flushing," the FDA said.
The regulator added, "There are no procedures to direct employees to wash hands with soap and water after toilet use and prior to gowning."
This is Ranbaxy's third unit to be issued an import alert from the USFDA after its Dewas and Paonta Sahib manufacturing units.
In May this year, Ranbaxy also pleaded guilty to felony charges, accepting to have sold adulterated drugs in the US and paid $500 million to US authorities as a penalty.