"The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.S. market meet federally mandated quality standards," Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a 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."
Under the FDA's alert, U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories Ltd.'s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices, FDA officials said.
The 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.
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 current good manufacturing practices.
This decree contains provisions to ensure current good manufacturing practices 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, officials said.
"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 federal Food, Drug, and Cosmetic Act or FDA regulations, including current good manufacturing practices," the FDA said.