US FDA warns Novartis on manufacturing violations at two India plants

The US Food and Drug Administration (FDA) warned Novartis AG last week after the Swiss firm was found violating manufacturing practices last year at two of its India drug-making plants.

The warning, issued to its generic drugs unit, Sandoz, on October 22, came after FDA officials inspected the Turbhe and Kalwa sites in August 2014. FDA expressed its concerns last year, and Novartis has been working on addressing these since, it stated while disclosing its quarterly results on Tuesday.

"Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction," the company said. FDA has banned supplies from about 30 drug manufacturing plants in India since 2013, as it ramps up inspections of foreign facilities that supply to the United States.