Sandoz Receives Warning Letter for Manufacturing Violations At 2 Indian Sites From US FDA

The warning letter was issued to Novartis's generic drugs unit Sandoz came after FDA officials inspected its Turbhe and Kalwa sites in western India in August 2014.

The US Food and Drug Administration (FDA) issued a warning letter to Sandoz, generic drug arm of Swiss giant Novartis for its two Indian sites at Kalwe and Turbhe on October 22.

The warning letter observations follow an agency inspection at both the sites in August 2014, the company said adding those are related to deficiencies in current good manufacturing practice (cGMP) for finished pharmaceuticals.

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"The warning letter does not contain any new issues versus the 483 observations issued following the inspection in August 2014, which Sandoz has been addressing since then," it added.

"Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction. No supply disruptions are expected," it said.

Novartis ($NVS) acknowledged the issues on Tuesday in its earnings announcement, and Novartis, CEO, Joseph Jimenez touched on them during Q3 earnings discussion. He said the FDA issued the warning letter for the sites in Kalwe as well as one in Turbhe, a plant that Sandoz intends to close. Jimenez said he expected the warning letter would soon be published by the agency.

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Jimenez gave no details about the agency's concerns but said that the company has been working on fixing the problems since the FDA raised red flags during an inspection in August 2014. The warning letter didn't include any additional concerns, Jimenez said. The company continues to ship products from the plants, and no supply issues have resulted from the episode.

Source-Medindia

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