FDA tissue inspections
This article was originally published in The Gray Sheet
Executive Summary
An inspection "blitz" on companies that recover human tissues for transplantation found no significant compliance problems, FDA's Human Tissue Task Force 1reports June 12. FDA inspected 153 U.S. tissue recovery firms from October 2006 through March 2007, and while some deviations from FDA's tissue regulations were found, there were no major deficiencies that could put patients at risk for disease transmission, the report says. The task force, which called for the inspections after serious violations were discovered at two tissue recovery firms last year, recommends that human tissue companies performing the highest-risk manufacturing steps be inspected every two years, and all others every three years (2"The Gray Sheet" Sept. 4, 2006, In Brief). FDA plans 484 tissue-facility inspections in fiscal 2007. More than 2,000 human cell and tissue establishments are registered with FDA, with 1.5 million musculoskeletal tissue transplants performed each year...