FDA 483 - Applied Tissue Technologies LLC - December 11, 2019

An FDA inspection of Applied Tissue Technologies LLC in Hingham, MA, conducted from December 10-11, 2019, identified one observation. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established. Specifically, the procedures lacked provisions for employing statistical methodology to detect recurring quality problems, and no CAPA was initiated despite multiple complaints regarding the same issue with a product's mincer blades.