Halts review of drug applications from Paonta Sahib, invokes compliance clause
The US Food and Drug Administration (FDA) on Wednesday announced that a facility owned by Ranbaxy Laboratories Ltd falsified data and test results in approved and pending drug applications.
The facility, Paonta Sahib, has been under an FDA import alert since September 2008.
The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site.
To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products, the regulator said in a press release.