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New Import Alert Requires Detention of Drug Products Manufactured at India Facility

Tuesday, September 17, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued Sept. 16 an import alert under which U.S. officials may detain at the border what press reports say are 11 drug products manufactured at the Mohali, India, facility of Ranbaxy Laboratories Ltd., India’s largest drug manufacturer. FDA inspections last fall identified significant violations of current good manufacturing practices at this facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality. Press reports indicate that all three of the company’s India facilities are now subject to FDA import alerts prohibiting them from shipping to the U.S. until certain conditions are met.

The FDA also ordered the Mohali facility to be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012. Under this decree, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at its Mohali facility and introducing drugs into interstate commerce, including into the U.S., from that facility until the methods, facilities and controls used to manufacture drugs at that facility are established, operated and administered in compliance with CGMP. Ranbaxy is required to hire a third-party expert to conduct a thorough inspection of the Mohali facility and certify to the FDA that the facilities, methods, processes and controls are adequate to ensure continuous compliance with CGMP. Once the FDA is satisfied that Ranbaxy has come into compliance with CGMP the company will be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility.

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