USFDA had conducted inspections at Ranbaxy's Mohali facility in 2012, resulting in certain observations," Ranbaxy said in the statement. "The company believes that it has made further improvements at its Mohali facility ... and remains committed to addressing all concerns of the USFDA."
The Mohali plant, in the northern state of Punjab, had not been making U.S. exports since last November, when it voluntarily recalled its generic version of cholesterol-lowering drug Lipitor in the United States due to the potential presence of glass particles in certain batches.
The FDA's ban of U.S. shipments from the Mohali plant was unexpected as the facility is relatively new and accounted for 50 per cent of new generic drug filings by Ranbaxy, said Sarabjit Kour Nangra, a sector analyst at Angel Broking.
The latest action against Ranbaxy came months after the FDA imposed an import ban on one of the plants of Wockhardt Ltd after inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area.
Wockhardt Chairman Habil Khorakiwala said this month the problem at its Waluj plant was "an inexcusable lapse, but we have taken swift and definitive action, both corrective and pre-emptive".
India produces nearly 40 per cent of generic drugs and over-the-counter products and 10 per cent of finished dosages used in the United States. In March, India allowed the FDA to add seven inspectors, which will bring its staff in India to 19.
In Ranbaxy's case, the FDA inspections in Mohali also found that a tablet was not within the specified weight limit, the FDA inspectors wrote.
Other findings by the FDA included use of dirty glassware, spots and abrasions on the surface of tablets and potential packaging line failure that resulted in unlabeled bottles sent to pharmacies.
The latest Ranbaxy import ban and a weak rupee may force Daiichi Sankyo to revise down full-year guidance when it announces first half earnings on October 31, Atsushi Seki, an analyst with Barclays Japan wrote in a report.
"It appears Ranbaxy still has problems that need to be resolved," Seki