Big Shakeup Underway With Hospira Management

Big Shakeup Underway With Hospira Management

April 18th, 2013 // 3:26 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

For more than a year, Hospira has made headlines thanks to a spate of ongoing, serious and systemic manufacturing problems that have led to numerous FDA inspections and warning letters. The situation has grown so worrisome that some speculate a consent decree is likely (read more here and here).

In hopes of making the intractable somehow manageable, the drugmaker last year hired John Elliott, who had run Cherokee Pharmaceuticals and spent more than a quarter of a century overseeing operations at GlaxoSmithKline (GSK). At the time, he was described as “a seasoned global leader” with loads of manufacturing experience and “specific expertise in injectable pharmaceuticals” (look here).

April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance

Now, though, he is being replaced. Earlier this week, the drugmaker shifted Matt Stober to senior vp of operations, which means he will oversee manufacturing science and technology, engineering, competitive strategy, health and safety, supply chain and procurement (see this). Stober, you may recall, was hired two years ago as part of an effort to fix the manufacturing issues (here his is compensation info).

He had previously worked at Johnson & Johnson (JNJ) and, before that, at Novartis (NVS), where he oversaw varoius technical operations. Since then, he was head of US pharma operations at Hospira (HSP) and primary responsibility for facilties in Rocky Mount, North Carolina; McPherson, Kansas; Austin, Texas; and Clayton, North Carolina, where so many manufacturing problems have occurred.

To what extent this will yield the desired result is unclear. Perhaps Stober was in the wrong spot initially and has since gained sufficient insight to make enough of the right changes. And maybe internal politics have shifted accordingly. Then again, he also oversaw the plants with the problems. In fact, one of the North Carolina plants was recently issued a 483 report by the FDA. Unlike certain injectable drugs, though, here is no shortage of available manufacturing experts.

 

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:

Updated Daily – Read our latest FDA, cGMP Compliance News


Subscribe Now

Featured Partner