FDA to Block Imports from Ranbaxy Drug Facility in India
The Food and Drug Administration issued a new import alert Sept. 16 to block imports of drug products manufactured at Ranbaxy Laboratories’ facility in Mohali, India. FDA also extended the terms of a 2012 settlement that covered other Ranbaxy facilities in India to also cover the Mohali facility.
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FDA’s import alert will result in detention at the border, or “detention without physical examination,” for all drugs made at the facility until Ranbaxy addresses alleged violations of current good manufacturing practice regulations. Meanwhile, FDA’s extension of the 2012 settlement to cover the Mohali facility means Ranbaxy is now barred from manufacturing FDA-regulated drugs at the facility and introducing them into U.S. commerce. The order can only be lifted once a third-party expert hired by Ranbaxy certifies that the company has brought its Mohali facility into compliance with CGMP regulations.