Resources for Food and Drug Administration (FDA)

FDA Does Not Inspect Chinese Drug Manufacturer Due To Mix-up

charlottesville.injuryboard.com

The Food and Drug Administration (FDA) failed to inspect a Chinese facility that supplies the active ingredient of heparin, a widely used blood thinner, because the facility's name was confused with another just like it. The FDA says, however, that the heparin case is one of their top priorities and a team of inspectors is on its way to investigate the plant as part of an effort to deduce what caused the sudden spike of problems with the drug, which has been on the market since the 1930's. There were 350 adverse reactions to the drug, including vomiting, breathing difficulties, low blood pressure, and death in four cases. Last week, the FDA advised doctors to start prescribing alternatives to heparin. While federal law does not require the FDA to inspect foreign drug manufacturers, the agency usually does perform inspections before allowing a new drug or ingredient to go to American consumers with an FDA stamp of approval.

View the Resource

Share or bookmarklet this web page at: