FDA Adds Another Site to Ranbaxy’s Consent Decree; Issues Import Alert

In an enforcement action industry experts say signals FDA doubts about the generic giant’s culture of quality, the agency Sept. 16 added Ranbaxy’s Mohali, India, facility to a consent decree it signed in January 2012, and issued an import alert on the plant, which makes oral solids. The other Indian plants subject to the consent decree, Paonta Sahib, Batamandi and Dewas, have been on FDA import alert since September 2008.
Washington Drug Letter