… and false statements to the FDA.
The settlement came after a series of investigations of Ranbaxy plants in Dewas and Paonta Sahib beginning in 2006, that did not however lead to the FDA pulling back drugs already on the market. In February 2009, the FDA imposed an Application Integrity Policy that effectively closed down further drug applications from Ranbaxy.
This week reports, including by Reuters, said that documents suggested that the black fibre embedded in the tablet was likely either “tape remnants on the nozzle head of the machine or a hair from an employee's arm that could be exposed on loading the machine.” The FDA’s latest decree saw Ranbaxy shares crash 35 per cent at one point on Monday’s trading. The firm gets more than 40 per cent of its sales from the U.S.
Ranbaxy was quoted as saying that it would review the details of the FDA import alert and take “all necessary steps to resolve the concerns,” at the earliest, adding that the FDA conducted inspections at Mohali in 2012 and that since then “the company believes that it has made further improvements at its Mohali facility.”
Neither the U.S. nor Indian regulators have prosecuted top Ranbaxy officials, including former owners of the company, brothers Malvinder and Shivinder Singh, who sold the company to Japanese Daiichi Sankyo Co in 2008 for $2 billion.