FDA has issued an import alert under which US officials may detain at the US border drug products manufactured at Ranbaxy Laboratories' facility in Mohali, India. The firm will remain on the import alert until the company complies with US cGMPs, according to a Sept. 16, 2013 FDA statement.
“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, in the agency statement. “We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country.”
FDA also ordered that the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012. 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.
The FDA exercised its authority under a provision in the consent decree permitting it 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 the Federal Food, Drug, and Cosmetic Act or FDA regulations, including cGMPs.
In September and December 2012, FDA inspections identified 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 United States, 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 cGMPs. Ranbaxy is required to hire a third-party expert to conduct an inspection of the Mohali facility and certify to FDA that the facilities, methods, processes, and controls are adequate to ensure continuous compliance with cGMPs. Once the agency is satisfied that Ranbaxy has come into compliance with cGMPs, Ranbaxy will be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility.
The agency does not anticipate that this action will cause a supply disruption or shortage of drugs in the United States.