FDA Halts Drug Production at Ranbaxy Plant
The agency has ordered the Toansa, India facility of Ranbaxy to halt drug production and distribution.
According to a press release from FDA, the agency has ordered the Toansa, India facility of Ranbaxy to halt all drug production and distribution for the U.S. market. The company is specifically prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs), and the Toansa facility is added to an existing consent decree initially entered against the company in January 2012.
The decree contains provisions to ensure the company complies with current good manufacturing practice requirements at facilities in Paonta Sahib and Dewas, India. FDA added Ranbaxy's Mohali facility in September 2013.
The action taken by FDA comes in the wake of an inspection of the Toansa facility on Jan. 11, 2014. FDA's inspection found several violations, in particular Toansa staff's retesting raw materials, intermediate drug products, and finished API after the items failed analytical testing and then subsequently not reporting the failures. Ranbaxy has been ordered to hire a third-party expert to inspect the Toansa facility.