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.
The FDA emphasized that failure to address the outlined issues could lead to further regulatory actions, including seizure, injunction, and civil money penalties. The letter also suggested the listed issues may point to more serious issues within Integra's manufacturing and quality control systems. Integra's subsequent recall and production halt followed consultations with the FDA and an internal investigation, indicating levels of endotoxins above permitted limits.
