FDA Approved the Wrong Drug Plant
March 11, 2008
According to the FDA, the Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected because the agency confused it with another plant that had the same name.
A team of FDA inspectors is now headed to China to inspect the correct plant, as part of an effort to determine what caused a sudden spike in serious reactions to heparin.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous drop in blood pressure, breathing difficulties, and vomiting. Four patients who took the drug died.
Federal law does not require inspections of foreign drugmakers, although the agency will in most instances inspect before a new foreign drug or active drug ingredient is allowed in FDA-approved prescription medications. Such an inspection does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.