The Food and Drug Administration has added a fourth Indian facility run by Ranbaxy Laboratories, to the list of sites prohibited from manufacturing and distributing active pharmaceutical ingredients for the US market.
Following an inspection of Ranbaxy's Toansa facility, which concluded on January 11, the FDA says it identified "significant Current Good Manufacturing Practice violations". These included Toansa staff retesting raw materials, intermediate drug products, and finished API "after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures".
Ranbaxy, which is majority-owned by Daiichi Sankyo, is required to hire a third-party expert to "thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with cGMP". The plant is now subject to certain terms of a consent decree entered against Ranbaxy in January 2012 which covers three other Indian facilities - in Paonta Sahib, Dewas and more recently Mohali.
Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said that "we are taking swift action to prevent substandard quality products from reaching US consumers". The agency is evaluating potential drug shortage issues that may result from the suspension and may modify the order.
In May last year, the company agreed to pay $500 million in fines under a settlement with the US Department of Justice after pleading guilty to cGMP violations and false data charges.