quality management: Hospira

Hospira is the world’s largest producer of generic injectable drugs and also provides delivery solutions for their products like infusion pumps and medication management.  Since 2009, they have received 4 warning letters and several Form 483 inspection reports (when company not adhering to established manufacturing regulations) from the FDA for adulterated products.  The quality issues affect multiple drugs and infusion pumps as well as damage Hospira’s image with their customers.

CEO Mike Ball has focused the company’s efforts on fixing the problems, which are spread throughout multiple manufacturing facilities.  They have changed operations leadership twice in the last 2 years and have spent hundreds of millions of dollars to update the manufacturing facilities in violation.  Analysts have speculated that the FDA may still issue harsher punishments but if they haven’t happened now, they probably will not.  The reasoning is that Hospira still makes drugs that are in critical need and further restrictions will only exacerbate shortages.  The FDA is trying to strike a balance between ensuring the public need is met and ensuring the drugs are safe to take.  Should the FDA be more focused on ensuring quality or alleviating drug shortages?

http://www.forbes.com/sites/edsilverman/2013/05/31/another-day-another-warning-letter-for-hospira-but-will-the-fda-issue-a-consent-decree/