FDA Orders Import Restrictions For Indian PlantBy: Sean Patterson - September 16, 2013
The U.S. Food and Drug Administration (FDA) today issued and “import alert” for drugs manufactured at a Ranbaxy Laboratories facility located in Mohali, India. Under the alert, U.S. customs officials can seize any of the products coming into the U.S.
This is not the first time Ranbaxy Laboritories has been cited by the FDA. This newest order includes putting the Mohali factory under the same permanent injunction that the FDA filed against Ranbaxy in early 2012. This means the facility, like others in Paonta Sahib and Dewas, will have to comply with FDA-mandated manufacturing practices.
“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 FDA’s Office of Compliance. “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 states that late in 2012, the Mohali facility was found to have multiple “current good manufacturing practices” (CGMP) violations. According to the FDA, the CGMP is the “primary” regulatory safeguard used to ensure quality. Ranbaxy Laboritories is now prohibited from making FDA-regulated drugs in its Mohali facility for import into the U.S. The company could, in theory, clean up its act and hire a third-party expert to ensure compliance. However, import alerts for Ranbaxy’s Paonta Sahib and Dewas facilities, issued back in 2008, are still in effect.