Is GSK Pressure on FDA Influencing Hospira 483 Failures?

Is GSK Pressure on FDA Influencing Hospira 483 Failures?

March 26th, 2013 // 3:45 pm @

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In recent months, we have seen major manufacturing issues with the Hospira facility in Rocky Mount, NC.  Hospira is reported to have spent upwards of a staggering $375 million since 2010 to bring its manufacturing facilities into FDA compliance.

Most of it has gone to the Rocky Mount plant. A major hiring blitz at the plant took place starting in 2010 for new quality assurance auditors and senior biological quality supervisors. Still, three years on into the compliance crisis, FDA inspectors still are not satisfied with the progress at the plant.

Inspectors still noted in a recent 483 some of the same manufacturing problems from 2010. FDA noted that there were major issues with cleaning in the area for aseptic process, and also problems ensuring that solution bags that were defective were removed from production.

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Another FDA 483 observation at Rocky Mount showed large amounts of various debris around conveyors, and written procedures were not followed. Some of the employees in the parenteral filling room could not recognize defects, and some employees couldn’t keep pace with manual inspections.

Problems have been noted by FDA at the Rocky Mount plant since a warning letter was issued in 2010. Since that time, Hospira has done a huge overhaul of its manufacturing plants in the US in Clayton NC, Austin TX and Boulder, CO. It has spent over $300 million, brought in legions of consultants and added many layers to its QC management.

Still, in the last year, Hospira has been forced to recall several products and had to lower investor expectations for a return to profitability. In the latest inspection, the firm had to issue three recalls of five different products, while the inspectors were still at the plant.

The Rocky Mount plant, which makes injectable drugs and supports Hospira’s contract manufacturing business, is a crucial one to the company. At full capacity, the site employs more than 2,500 and accounts for 25 percent of Hospira’s nearly $4 billion in annual revenue.

In a recent Webinar, one of our speakers noted that Hospira had paid a staggering $100 million to a dozen consultants, and the problems with the plant continue. He also noted that GSK is interested in purchasing Hospira. He speculated that GSK may be using some of its leverage with the agency to put regulatory pressure on Hospira, which could lower the stock price. According to our source, GSK has a great deal of pull with FDA, and this could be contributing to the ongoing scrutiny at Hospira.

We have another industry source that told us at least two recent warning letters to large pharmaceutical companies resulted from competitors lobbying FDA for more scrutiny of certain companies. This sort of thing may be going on in the industry more than some realize.

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