FDA issues warning letter for Novartis Ebewe plant

Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis ($NVS) got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.

A warning letter issued last week and posted Tuesday on the FDA website says the FDA told folks at an Ebewe Pharma plant in Unterach am Attersee "several times, in writing and orally, not to distribute the implicated product until you received approvals. Further, the FDA informed the company "in writing on March 14, 2012, that these supplements were not approvable." Ebewe became part of Sandoz in 2009 as part of a $1.3 billion acquisition.

Inspectors found problems with the plant's methods of visually inspecting for "critical defects, such as particulate matter in finished parenteral drug vials," saying they missed visible particles in batches at least 10 times. That led the FDA to question whether Ebewe has a "robust" enough visual inspection program. The agency wants some kind of game plan from Sandoz as to what it intends to do about the products already in the U.S. market.

A spokesman for Novartis told FiercePharmaManufacturing Wednesday that the company does not expect to recall any of the products manufactured at the plant. The company said it had not heard of any adverse effects and does not expect any supply interruptions as a result of the action. In a statement, Ameet Mallik, Sandoz's head of biopharmaceuticals & oncology injectables, said: "We take seriously the warning letter observations cited by the FDA and will work closely and expeditiously to address these concerns to the agency's full satisfaction. Sandoz has made strong progress in strengthening operations in Unterach through significant investments in both resources and state-of-the-art technologies. We remain deeply committed to fully addressing all outstanding issues and meeting all quality standards."

Austria is not the only place where Sandoz has had difficulty meeting FDA expectations. In 2011, the FDA sent Sandoz a warning letter laying out issues it had with plants in Broomfield, CO; Wilson, NC; and Boucherville, Quebec. Late last year, the FDA removed the Broomfield plant from its warning letter watch list, and Novartis CEO Joseph Jimenez has indicated that the other two are making progress toward returning to the good graces of the U.S. agency. But in May, Sandoz voluntarily recalled two lots of methotrexate sodium due to visible particles.

The company has also had long-running problems at its consumer health plant in Lincoln, NE, which have been a drag on earnings and a particular sore point for Jimenez. In April, the company said it was going to narrow its manufacturing focus to solids and powders and ax 300 workers, which is about 40% of the workforce there. 

- here's the warning letter
- and the Sandoz statement
- read FiercePharma's take