FDA investigates Ranbaxy factory in India

ROCKVILLE, Md. The Food and Drug Administration has taken new action against a plant owned by generic drug maker Ranbaxy that has been subject to an import alert since September, the agency announced Wednesday.

The FDA said that Ranbaxy's factory in Paonta Sahib, India, falsified data and test results in approved and pending drug approval applications. The agency said it has not found evidence that the drugs to not meet quality standards and has not found risks to public health associated with currently marketed Ranbaxy products.

"Companies must provide truthful and accurate information in their marketing applications," FDA Center for Drug Evaluation and Research director Janet Woodcock said in a statement. "The American public expects and deserves no less."

The FDA has invoked its Application Integrity Policy against the Paonta Sahib plant. Under the AIP, the agency has asked Ranbaxy to cooperate in resolving the issue of data integrity and reliability, including implementing a Corrective Action Operating Plan to provide assurance of the integrity and reliability of data from the plant. The agency has also stopped all substantive scientific review of drug approval applications from data originating at the Paonta Sahib plant.

"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy," CDER Office of Compliance director Deborah Autor said in a statement. "Today's action the FDA's continued vigilance and its steadfast commitment to safeguarding the public's health."

The FDA barred the entry of finished drug products and active pharmaceutical ingredients from Ranbaxy's plants in Paonta Sahib, Dewas and Batamandi Unit when it found they had violated the agency's current Good Manufacturing Practices requirements. The action remains in effect and bans the importation of 30 generic drugs from the plants.