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XMFHelical (< 20)

Next they'll be telling us they all look the same too.



February 21, 2008 – Comments (0)

This should probably be a Bent blog - along the lines of 'you can't make this stuff up'.  [Might have been, I haven't had time to read blogs lately]

There have been recalls lately related to heparin, an anticoagulant used for many applications, such as when putting in an IV.  The product sold by Baxter has been linked to some allergic reactions (leading to a few deaths), prompting recall and review. 

Well, it turns out that the key ingredient in the drug product is manufactured in China, in a factory that was never FDA inspected.  Why?  Well to hear the FDA tell it, they thought they had inspected it because the name was similar to another factory. 


The drug product (which includes chemical, solution, bottle, and everything else is manufactured in Wisconsin at Protein Scientific Laboratories, which is being re-inspected.  They should have documentation and test data on all raw materials as well.

An agency known for rigor, and possibly excessive rigor in some cases, simply can't make that kind of mistake (and didn't Baxter know the factory hadn't been inspected??).  Welcome to outsourcing and the global economy.  These are boom trends in pharma research and manufacturing.  Clearly oversight is critical.  Shame on the FDA, shame on Baxter as well.

My favorite line from a Boston Globe story Tuesday on the incident was a summary comment from an FDA deputy director -- 'as far as the FDA knows, it is an isolated incident'.  'As far as the FDA knows' is really the point now isn't it.

Zz (Ralph)

Anyone else sensing a major backlash against Chinese manufacturing?  Toys, pharma, furniture -- just about everything.  Strap on your inflation belts.

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