FDA Blocks Drug Imports from Plant in India
Over violations of manufacturing rules
MUMBAI—The U.S. Food and Drug Administration said it is blocking imports of medicine made at the newest plant of India's Ranbaxy Laboratories Ltd., again casting doubt on the quality of pharmaceutical products from the South Asian country, the U.S.'s largest supplier of generic drugs.
The FDA issued an import alert Friday for drugs made in Ranbaxy's Mohali plant in northern India. On Monday the agency said it found "significant" violations of manufacturing rules, "including failure to adequately investigate manufacturing problems" during two plant inspections conducted in September and December 2012.
The agency said Ranbaxy won't be allowed to make drugs for the U.S. at the Mohali site until the company comes into compliance with FDA manufacturing rules. Ranbaxy will be required to hire a third-party expert to inspect the Mohali facility and certify to the FDA that any violations have been addressed and that the company has processes in place to ensure continuing compliance.