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Biotech / Medical : Biotech News
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From: tom pope2/18/2008 6:28:01 PM
   of 7143
 
Isolated instance, I hope. Did the factory they inspected even make the suspect product?

WASHINGTON - US health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said on Monday.

Baxter International's heparin has been linked to four deaths and hundreds of reports of allergic reactions. An investigation will take health inspectors to China this week.

The Chinese manufacturer was not inspected because it was confused with another company in the agency's database with a similar name, said Mr Joseph Famulare, deputy director of the Centre for Drug Evaluation and Research's compliance department. The FDA evaluated that firm, which had a history of positive inspections and was not re-inspected.

The agency discovered within the past month that the wrong factory was evaluated, Mr Famulare said, adding that as far as the FDA knows, it is an isolated incident.
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