FDA confirms Novartis plant, renewing CEO's confidence

Novartis CEO Joseph Jimenez

The FDA has removed a Novartis ($NVS) plant in Colorado from its warning letter watch list, a development that Novartis CEO Joseph Jimenez says shows the company is getting its manufacturing act together.

In an emailed statement, a Novartis spokeswoman explained. "The FDA confirmed on November 7, 2012 that our Sandoz manufacturing site in Broomfield, Colorado, one of three sites referenced in the November 2011 Warning Letter, has achieved positive compliance status following a re-inspection in August. We welcome this development, which we see as a significant milestone in our remediation efforts across all three sites. Wilson and Boucherville are currently pending FDA re-inspection and all commitments to FDA and Health Canada are on track."

Jimenez, in an interview with a German newspaper, said, "This development makes me confident. We are on the right track but must not stop," Reuters reports.

During an earnings call last month, Jimenez found himself on the defensive about the company's extensive list of manufacturing issues. He had to explain again that the company had again underestimated how long it would take to get its over-the-counter plant in Lincoln, NE, up an running. The plant accounts for about 25% of the company's OTC products and its closure resulted in a 22% drop in OTC sales in the last quarter, a quarter in which Novartis' overall sales dropped 7%. There were still the issues being addressed at the three Sandoz plants cited a year ago in a warning letter, and Italy and other countries were putting holds on Novartis flu vaccine made at a plant in Siena, Italy.

The questions over the flu vaccine have been resolved and were never a manufacturing problem, Jimenez told the German newspaper. The CEO earlier this year initiated a campaign in which he exhorted employees to concentrate on quality, saying that the missteps the company has made had undermined consumer confidence in Novartis.

- read the Reuters story
- here's the warning letter

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