A Florida firm that supplies human tissue implants to the U.S. and the world is now under fire for producing body parts and products contaminated with bacteria, fungi and other potentially dangerous organisms, according to federal health regulators. Food and Drug Administration officials posted a warning last month saying they had found apparent widespread contamination throughout the Alachua, Fla., site operated by RTI Biologics Inc. Human tendons used to heal sports injuries and “bone putty” that helps repair fractures were among contaminated products, along with sites and processes, detected at the plant that produces tissue used in all 50 U.S. states and more than 30 countries worldwide.
FDA officials had not said at press time whether they had received reports of infection, illness or death linked to RTI products. But company officials in a statement said there have been no reports of disease and that no contaminated products were distributed to the public. An FDA inspection document from 2011, however, indicated that RTI had received 758 internal reports of a wide range of complaints or adverse events in a year, including four reports of infections that were sent on to FDA. Under federal law, the FDA regulates tissue, but it’s up to companies to decide when to pass complaints on to the agency.
Records indicate the FDA sent inspectors to the plant in 2008, 2010 and 2011, as well as during the most recent visit from June 25 to July 11, 2012. But the FDA stopped short of taking stronger action to limit RTI’s distribution of implants, including bones, skin, tendons, ligaments and other tissue obtained from donors in the U.S. and elsewhere.
Source: NBC News
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