FDA Says Ranbaxy Plant Falsified Data, Results

FDA Says Ranbaxy Plant Falsified Data, Results. By Jennifer Corbett Dooren and Jared A Favole
WSJ, Feb 26, 2009

The Food and Drug Administration said a manufacturing plant owned by Ranbaxy Laboratories Ltd. falsified data and test results in approved and pending drug applications.

The agency said it was halting the review of drug applications made at Ranbaxy's Paonta Sahib plant in India. Last September, the FDA banned Ranbaxy from importing more than 30 generic drugs into the U.S. because of manufacturing violations it found at two company plants in India, including Paonta Sahib, making it likely that most products made at that plant are no longer on U.S. shelves. Such drugs include generic versions of the cholesterol-lowering drug Zocor and the heartburn treatment Zantac.

The Justice Department had been investigating whether Ranbaxy made false claims and fabricated data to get FDA approval for generic drugs. It's unclear whether the probe is continuing.

Deborah Autor, the director of the FDA's Office of Compliance, said most of the falsified data involves required tests to prove drugs are stable over a certain time period.

The FDA said it hasn't identified any health problems with drugs made at the Paonta Sahib site and said consumers shouldn't stop taking medications made by Ranbaxy. "To date the FDA has no evidence that these drugs do not meet their quality specifications," the agency said in a statement.

Agency officials said they have tested about 80 drugs made by Ranbaxy and so far haven't found any problems with the drugs themselves. They also said they have conducted more than 20 inspections of four Ranbaxy facilities in India and U.S. facilities since 2005.

In a statement, the company said: "Ranbaxy will continue to co-operate with the USFDA," adding "no effort or action will be spared" to protect some pending drug applications before the agency from the Paonta Sahib plant.

The problems were uncovered during a 2006 inspection of the Paonta Sahib plant. Among other things, FDA inspectors found hundreds of drug samples meant for required stability testing stored in refrigerators even though the samples should have been stored at room temperature.
FDA inspectors found that logbooks didn't identify which samples were in the refrigerator or how long they had been there. The FDA issued a June 15, 2006, warning letter to the company.
The FDA also said it found problems with signatures on records during a March 2008 inspection for a drug. and found that some records submitted to the FDA contained signatures or initials of Ranbaxy employees who weren't present in the facility on the dates mentioned in the records.