The FDA has suspended all new drug applications from one of Ranbaxy’s plants in India—the Paonta Sahib plant—after “determining the facility was falsifying scientific data.” You may recall that last September the FDA banned the import of 30 popular generic meds made by Ranbaxy due in part to quality control issues from this very same plant. What do they think they are, a peanut butter factory?
So what type of data was falsified? Info regarding the shelf life of products, and data concerning production practices.
To be clear, it’s applications for new drugs that have been suspended. Nothing is being pulled off the market and there are no reports of anything bad happening to anyone.
“FDA Halts New Applications From Indian Drug Maker’s Plant” [U.S. News & World Report]