Federal health investigators indicate that serious deficiencies and contaminants have been found at a Florida facility that makes biological implants from human tissue and body parts.
Earlier this week, the FDA released a warning letter sent to RTI Biologics in October, stating that the human tissue implant maker failed to store, process, package, and label its products in a way that prevents the spread of communicable diseases.
The findings outlined in the letter raise serious concerns about the safety of the human tissue implants that may have been shipped to medical providers worldwide.
RTI Biologics is known mainly for the production of human tendons used to treat sport injuries and bone putty products used to treat broken and fractured bones.
Inspectors found bacteria on finished product packaging for RTI’s sports medicine products on 70 separate occasions. The letter states that some finished products contained fungus, yeast and bacteria like Bacillus species and Pseudomonas aeruginosa. Pseudomonas aeruginosa is a pathogen that can cause pneumonia and skin and soft tissue infections.
Bacteria that could cause staph infections was found on one occasion, and Pseudomonas species bacteria was found in the water supply used to clean tissue processing areas and other locations on multiple investigations.
RTI Biologics has attempted to address some of the FDA’s complaints involving their production facility in Alachua, Florida, the letter notes. However, the federal health regulatory agency continues to have serious concerns.
“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,” the letter warns.
The FDA has warned that if RTI does not properly address the contamination problems it could face further action, including human tissue implant recalls, destruction of inventory or an order to cease operations.