Its Waluj manufacturing facility in Maharashtra failed to meet the good manufacturing norms prescribed by the UK drug regulator.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co and gets more than 40 per cent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.
Markets extended losses to end 1.5% down on Tuesday, amid weak global cues, after investors turned cautious ahead of key economic data and booked profits in rate sensitive shares while the further fall in the rupee continued to weigh on investor sent.
And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India