FDA blocks drug products from Ranbaxy facility in India

September 18, 2013

FDA has issued an import alert authorizing border control officials to detain drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The agency said action is warranted because Ranbaxy is not complying with U.S. manufacturing requirements.

FDA has issued an import alert authorizing border control officials to detain drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The agency said action is warranted because Ranbaxy is not complying with U.S. manufacturing requirements.

“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.”

Since 2008, similar seizure orders have been in place for drug products manufactured at Ranbaxy’s Paonta Sahib and Dewas facilities. Last year, FDA inspections found serious manufacturing violations at Ranbaxy’s Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality. 

FDA said it does not expect the import alert to cause a supply disruption or shortage of drugs.