Ranbaxy Compliance Issues Lead FDA to Halt Application Reviews

The FDA’s application integrity policy (AIP) has been invoked for all Ranbaxy drug applications that include data from the plant, the agency said last month. Under the AIP, the FDA will stop “all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility,” the agency says in a statement.

“Ranbaxy has the option of withdrawing any affected applications or subjecting them to a validity assessment to assure FDA of the integrity of the data contained in the applications,” Deborah Autor, director of the Center for Drug Evaluation and Research’s Office of Compliance, told reporters during a conference call announcing the use of the AIP with Ranbaxy.
Drug GMP Report