FDA visits wrong facility in China, heparin goes uninspected

WASHINGTON The Food and Drug Administration never inspected the Chinese facility that supplies the active ingredient of the blood thinner heparin because the agency confused its name with another just like it, agency officials said.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden increase in serious problems with the drug.

More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. One of its two manufacturers, Baxter International, stopped selling its multiple-dose vials of heparin earlier this month, and yesterday the FDA advised doctors to prescribe alternatives. The agency and Baxter are investigating whether differences in the ingredients from China could have caused the dangerous reactions in some patients.

According to the FDA, Chinese drug regulators, who sometimes do not visit facilities manufacturing for foreign markets, have not inspected that plant. Baxter has said that it had sent its own representatives there to ensure proper manufacturing procedures were being followed six months ago. The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.