Ranbaxy plant falsified data: FDA

Agency officials said they had not identified any health risks from Ranbaxy drugs on the market but were continuing to investigate products associated with the plant.

8220;The FDA8217;s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications,8221; said Deborah Autor,director of compliance in the agency8217;s drug center.

The action 8220;has limited significance for US marketed products8221; because the FDA banned imports from the facility in September due to manufacturing problems,Autor said.

Patients should not stop taking Ranbaxy drugs but should consult a doctor if they are concerned,FDA officials said.

A Ranbaxy official had no immediate comment.

The FDA said it had asked Ranbaxy to help resolve questions of data integrity and reliability for drugs made at the plant or some that were backed by data from the site. Plans for correcting the problem should include a third-party audit of drug applications linked to the plant,the FDA said.

In September,the FDA banned more than 30 generic drugs from entering the United States that were made at Ranbaxy plants inPaonta Sahib and Dewas,India. The drugs included cholesterol-lowering drugs,AIDS medications and antibiotics.

Japanese drugmaker Daiichi Sankyo holds a controlling stake in Ranbaxy.