Despite a voluntary recall of regenerative tissue technologies and a production halt at its Boston facility, Integra LifeSciences is facing continued regulatory issues, according to a recent FierceBiotech article. An FDA warning letter, dated July 17th, and recently made public, acknowledges Integra's attempts to address problems but finds them inadequate. Key concerns revolve around the handling of faulty products. The FDA noted a case where the company released a lot of Durepair collagen matrix without conducting a proper investigation, even though tests showed high levels of bacterial endotoxin. While Integra blamed the abnormal results on a transcription error, the FDA criticized the company's processes to prevent the release of non-conforming products.
