FDA has issued 43 warnings to drug companies about shoddy manufacturing since 2009
The U.S. Food and Drug Administration (FDA) has issued 43 warning letters to drug companies since January 2009 for manufacturing practices that potentially expose users of their medications to health risks. Additionally, from 2002 to 2006, more than half of U.S. drug plants and 62 percent of foreign plants that supply drugs to the U.S. were found to have violations requiring correction.
The violations noted in the FDA warning letters included safety recalls of propofol—an injectable drug administered by anesthesiologists during surgery—because of lack of proper bacterial testing and findings of steel particle contamination. Another plant that makes an ingredient used in antacids sent out products containing water that the company knew was contaminated with bacteria. Yet another plant was warned that it failed to properly investigate consumer reports of insect parts in five of its medicine products. And a drug and cosmetics plant in Puerto Rico was found to have several types of bacteria on its equipment and was admonished for failing to investigate 198 complaints regarding one of its products.
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