Defective Drugs Manufactured Abroad Without FDA Approval

May 23, 2014
by Adler Markoff & Associates

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    Defective Drugs Manufactured Abroad Without FDA Approval

    According to a report by the US Government Accountability Office (GAO), the Food and Drug Administration (FDA) has failed for years to adequately inspect foreign facilities that manufacture drugs for the United States. Because most of the prescription drugs and dietary supplements consumed by Americans were produced at least in some part in a foreign facility, Americans have no way of knowing whether the medications they take to improve their lives could be endangering them. If you suspect that you have a taken a drug that may have been produced in a foreign facility, consult a defective drug injury lawyer right away.

    FDA Drug Approval


    GAO found that the FDA inspected 424 facilities in 2009, and only 324 in 2008, out of the 3,765 foreign facilities. That means in 2009, the FDA inspected barely 11% of the facilities that make drugs and medications for American consumers. About 2,400 facilities – over 60% of the establishments – have never been inspected at all.

    When government agencies fail to inspect and monitor manufacturing practices at foreign facilities, it is American consumers who suffer but Americans cannot protect themselves. Consumers cannot tell whether the prescription drugs and dietary supplements they are taking were manufactured in the United States or in a foreign country. There is simply no way for consumers to know whether the drugs they are taking were made in a safe and inspected facility or not.

    Worse still, foreign facilities produce 80 percent of the pharmaceutical ingredients and almost 40 percent of finished prescription medications consumed in the United States. That means an American consumer taking prescription drugs is most likely taking a medication that was at least partially produced in an uninspected foreign facility.

    The FDA’s failure to inspect these facilities can have drastic and deadly consequences. In 2007 and 2008, about 100 people died from using counterfeit Heparin that was manufactured at a facility in China. Last year Yaz birth control pills were recalled for substandard manufacturing practices at a facility in Germany.

    Because the FDA fails to inspect the foreign facilities, the manufacturers could be producing defective drugs and consumers would have no way of knowing whether their medications are safe until it is too late.


    If you or someone you love has been victimized by defective drugs produced in uninspected foreign facilities, then you should know your legal rights. Contact a defective drug lawsuit attorney at AMA Law for a free legal consultation.

    Request a free consultation

    (405) 607-8757