|Hospira CEO F. Michael Ball|
The FDA earlier this month dashed the hopes of Hospira ($HSP) that its Rocky Mount, NC, plant was finally out of the woods when it handed executives a 21-page inspection report detailing 20 observations, many of them with multiple points.
During the company's earnings call in February, CEO F. Michael Ball said the company was anticipating that the inspection would show the plant was on the right path and production could be ramped up so Hospira could sell more drugs and improve its earnings. But the inspection document posted this week on the FDA's website shows how wrong they were. It does not paint a pretty picture for a company that has spent hundreds of millions of dollars and more than a year of consulting time trying to get its manufacturing in order.
Observations include seeing substantial amounts of debris around conveyors, written procedures that were not followed, employees on the parenteral filling area that couldn't recognize defects and employees that couldn't keep up with manual inspections. There were problems with cleaning in the aseptic processing area and problems with making sure that defective solution bags were taken out of production.
In fact, while inspectors were in the plant the company issued three recalls of 5 different products, some after customers found either a loose crimp or no crimp on the flip-top vials.
Problems at the Rocky Mount plant were first noted in a warning letter in 2010. Since then, the company launched into a major overhaul of its U.S. manufacturing network including plants in Clayton, NC, Austin, TX, and Boulder, CO. But over the course of the last year, the company has repeatedly had to recall products and adjust expectations for investors.
- read the report