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Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant
Date:2/18/2008

Agency error means facility linked to fatal lots of injected heparin was ignored, officials say

MONDAY, Feb. 18 (HealthDay News) -- Due to a name mix-up, the U.S. Food and Drug Administration (FDA) failed to inspect a Chinese plant that made the active ingredient in vials of heparin now linked to four U.S. deaths, the agency said in a Monday press conference.

The vials of multi-dose injectable heparin -- suspended from the market earlier this month by the manufacturer, Baxter Healthcare Corp. -- may have caused severe allergic reactions in American patients, four of which proved fatal.

Generally, the FDA inspects all foreign plants that make pharmaceuticals imported into the United States.

However, "when this site was named in the application [by Baxter], the firm selected and sent to the office of compliance for evaluation was not the correct firm. It was another firm with a similar name. We therefore evaluated the firm, with a similar name. Therefore, this particular firm was not put forward for evaluation," said Joseph Famulare, deputy director of FDA's Office of Compliance.

"We have discovered that; we are acting on that by doing our immediate inspection," Famulare said. "Today, this is isolated situation, but the wrong firm was put in to the database. Therefore, this one was not evaluated or scheduled for inspection," he said.

The agency is continuing its investigation into the source of the error, officials said.

A spokesman for China's State Food and Drug Administration told The New York Times on Friday that the FDA-inspected plant was not a drug manufacturer but "a producer of chemical ingredients" and not licensed to make pharmaceutical products.

Michael Rogers, director of FDA's Division of Field Investigations in the Office of Regulatory Affairs, is spearheading the investigation. He told reporters that the agency is uncertain as to what is causing the adv
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