Hospira 483 Shows Killer Manufacturing Issues

Hospira 483 Shows Killer Manufacturing Issues

March 26th, 2013 // 3:06 pm @

April 21 – $500K on Compliance or $300 Million for Consent Decree? – Essential FDA Compliance Tips for Sr Management

When Hospira ($HSP) acknowledged this month that FDA inspectors were still dissatisfied with progress at its Rocky Mount, NC, plant, it left out any details about what led them to their conclusions. The FDA has now posted its inspection report to its website, and 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.

April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance

Inspectors noted 20 observations, some of them with multiple findings, in a 21-page report. They noted problems with cleaning in the aseptic processing area and problems with making sure that defective solution bags were taken out of production. Observations included seeing substantial amounts of debris around conveyors, written procedures that were not followed, employees in the parenteral filling area who couldn’t recognize defects and employees who couldn’t keep up with manual inspections.

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. It has invested more than $375 million, brought in consultants and added to its quality-control management. But over the course of the last year, the company has repeatedly had to recall products and adjust expectations for investors. 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.

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CEO F. Michael Ball told analysts in February that the results of that inspection would affect its earnings for the year. But that issue was overshadowed the next day when it retracted its financial projections after the FDA banned Hospira from importing infusion pumps made at a plant in Costa Rica because of manufacturing problems.

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