Novartis employees may take ceo Joe Jimenez seriously when he insists that quality matters (remember this?), but the FDA is not taking him at his word. Once again, the agency has issued the drugmaker a warning letter and, this time, the subject is the Ebewe Pharma generic injectables business in Austria, which last year experienced production problems that led to shortages and at least one product ban.
The warning letter is only the latest sent by the FDA to Novartis concerning manufacturing issues at different facilities. Over the past two years, the agency has found infractions at a Sandoz plant in Canada and two others in Colorado and North Carolina in the US (see here and here), and the drugmaker also failed repeated inspections at a Nebraska plant that has since scaled back production to a select number of products (see this).
The growing FDA interest in Novartis facilities reflects a wider effort by the agency to crack down on manufacturing violations over concerns about the veracity of the pharmaceutical supply chain. And the agency has increasingly taken what can be termed a holistic approach to inspecting and tracking specific companies that are suspected of having systemic problems. Given the far-flung nature of its manufacturing ills, Novartis may be seen as fitting this pattern.
Clearly, the drugmaker has been on the defensive. Several weeks ago, for instance, Novartis made a point of noting that there were 58 inspections by health authorities, including 10 by the FDA, during the first quarter of this year and "the majority were assessed as good or satisfactory," although specifics about failures or ongoing problems at individual locations were not provided (back story).
In any event, the FDA found during an inspection last October that Ebewe failed to obtain prior approval for making changes in established quality control procedures before distributing products. And there was also a failure to visually inspect “critical defects, such as particulate matter in finished parenteral drug vials.” As a result, employees “repeatedly failed to detect visible particles,” according to the May 28 warning letter (here is the FDA letter).
Some background: Novartis purchased Ebewe four years ago for $1.3 billion and spent considerable time upgrading facilities. But last year, the Sandoz unit experienced unspecified issues that caused product shortages, and the Lebanese Health Ministry banned one drug due to several instances in which degeneration was detected 15 months or more after it was manufactured (back story).
Meanwhile, a Novartis (NVS) spokesman writes us to say that "Sandoz takes the two observations cited in the letter seriously and will work closely with the FDA to address the observations. Sandoz and Novartis are deeply committed to providing our patients with high-quality product, which is our highest priority."
[UPDATE: Novartis now sends us this: “We take seriously the two warning letter observations cited by the FDA and will work closely and expeditiously to address these concerns to the agency’s full satisfaction,” Ameet Mallik, Sandoz head of biopharmaceuticals & oncology injectables, says in a statement. “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.” Since 2011, Sandoz is not aware of any adverse events in products manufactured at the Unterach site associated with the observations in the letter. The company does not anticipate any related product supply issues at this time.]
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