December 14, 2012 — RTI Biologics has received a Warning Letter from the U.S. Food and Drug Administration (FDA) after investigators found contamination issues at the facility. RTI sells human tissues (mostly tendons, ligaments, bones, and skin), and “bone putty” used to heal bone fractures. The products are mostly used in sports medicine surgeries. Investigators found dozens of products contaminated with fungus, bacteria, and yeast, including some bacteria that can cause life-threatening infections.
The FDA investigators found that RTI received more than 758 complaints in 2011 alone, including 4 reports of infections. FDA testing of found that 70 implants tested positive for Pseudomonas bacteria between January 1, 2011 and June 30, 2012. They also found Bacillus, Serratioa, and Staphylococcus bacteria, which could potentially cause infection, as well as fungus and yeast. The investigators also found issues with the company’s sterilization process, including bacterial contamination in the company’s water supply.
Florida District Director Emma R. Singleton wrote in the warning letter,
“We remain concerned about the conditions that were identified during the most recent inspection and the ongoing contamination issues that appear to be problematic throughout your facility.”
Last year, RTI sold more than 33,000 human tendons, which are used in knee, ankle, and other joint surgeries. The company sells non-organ body parts in all 50 states and in several foreign countries. Ongoing contamination issues raise concerns about widespread outbreaks of infection linked to the implants.
RTI is already facing dozens of lawsuits stemming from a body-harvesting scandal in 2005. The company purchased body parts from Michael Mastromarino, who is currently in prison for harvesting organs from dead people and selling them without gaining permission from the donor or the family.
The FDA asked RTI to respond to the warning letter in 15 days outlining how they would address the contamination issues. The FDA also warned that they could take further regulatory action, including recalling contaminated body parts, destroying inventory, or prohibiting them from selling human tissues.
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