Agency issues import alert and adds this facility to existing consent decree until such time as company complies with cGMP
The US Food and Drug Administration has issued an import alert under which officials may detain at the US border drug products manufactured at Ranbaxy Laboratories’ facility in Mohali, India. The import alert will remain in place until the company complies with current good manufacturing practices (cGMP), the FDA says.
'The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the US market meet federally mandated quality standards,' said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER). 'The FDA will continue to work to prevent potentially unsafe products from entering the country.'
Using its authority under a provision of the consent decree of permanent injunction entered against Ranbaxy in January 2012, the FDA also ordered that the Mohali facility be subject to certain terms of. The decree contains provisions to ensure cGMP compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, India, as well as provisions addressing data integrity issues at those two facilities. Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008. It also permits the FDA to order that terms of the decree be extended to a Ranbaxy-owned or operated facility if an inspection determines that the facility is in violation of FDA regulations, including cGMP.
In September and December 2012, FDA inspections identified significant cGMP violations at Ranbaxy’s Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.
Under the decree, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the US, from the Mohali facility until the firm’s methods, facilities and controls used to manufacture drugs at the Mohali 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 agency 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.