FDA issues import alert on drug products manufactured at Ranbaxy's facility in Mohali, India Published on September 17, 2013 at 12:53 AM

FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy's Mohali, India, plant and issues import alert

Agency issues import alert and adds this facility to existing consent decree
The U.S. Food and Drug Administration today issued an import alert under which 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 (CGMP).
"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," said Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "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."
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. 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.
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