February 19, 2008 | Mark Paradies

FDA Checks Wrong Plant – Maybe They Need to Apply Advanced Root Cause Analysis?

Two different plants. Two similar names. Oops! Wrong plant!

If you’ve been following the FDA investigation of allergic reactions to Baxter’s heparin blood thinner, you know that a Chinese manufacturer is supplying a key ingredient. The supplier that produces the ingredient was not previously inspected by the FDA because the FDA went to the wrong plant. It seems there are two plants with similar names in the agency’s database.

Joseph Famulare, Deputy Director of the Compliance Department at the FDA’s Center for Drug Evaluation and Research, said that the wrong factory had a history of positive inspections and wasn’t re-inspected. This month, they discovered their error. Famulare says that, as far as the FDA knows, this is an isolated error. FDA inspectors will travel to China this week to check the right plant.

The FDA has notified Doctors to stop using Baxter’s heparin because of 350 reports of adverse reactions (including deaths) this year.

For more information, see the Associated Press story at:


Root Cause Analysis
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