The U.S. Food and Drug Administration has prohibited Ranbaxy Laboratories in Toansa, India, from manufacturing and distributing active pharmaceutical ingredients for FDA-regulated drug products.
The laboratory now is subject to terms of a consent decree of permanent injunction filed in January 2012 against Ranbaxy's facilities in Paonta Sahib, Batamandi and Dewas, India, to ensure the facility complies with current good manufacturing practices.
The consent decree allows the FDA to extend the decree's terms to any Ranbaxy-owned or operated facility if it is found to be in violation of FDA regulations.
The FDA recently inspected the Toansa facility and "identified significant CGMP violations," according to the news release, including retesting raw materials and failing to report proper test results.
Ranbaxy now has to hire a third-party expert to observe and inspect the facility to ensure it complies with CGMP and FDA regulations.
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