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Last Updated: Jun 30, 2008 - 11:14:37 AM |
MONDAY FEB 18, 2008 (Foodconsumer.org) -- The Food and Drug Administration said MONDAY it did not inspect the Chinese factory that is suspected to have something to do with serious adverse effects associated with Baxter’s heparin. Rather, the agency inspected a wrong factory due to the confusing similarity between the two company names.
Baxter's heparin made of an ingredient manufactured in China has been linked to four deaths and hundreds of allergic reactions.
It was found that the FDA has never inspected the Chinese manufacturer that makes the active ingredient for Baxter’s heparin and the agency received criticism for that inactivity.
The agency said a team consisting of a chemist fluent in Chinese and an expert in drug manufacturing technology will travel this week to China to inspect the factory, according to Michael Rogers, director of the division of field investigations within the FDA's regulatory affairs office.
So far, the FDA does not know what causes the deaths and allergic reactions linked with use of Baxter's heparin, a blood thinner that is often used during heart surgery.
To probe the incident, the agency will also inspect a Baxter facility in Cherry Hill, NJ and at a company supplier Scientific Protein Laboratories of Waunakee, Wisconsin.
Last week, physicians were told not to use Baxter's heparin because 350 cases of side effects have been reported so far this year.
Baxter also stopped manufacturing multiple-dose vials while the joint-investigation into this incident is ongoing. The drug maker also recalled nine lots of the injectable drug last month after allergic reactions among dialysis patients were reported.
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