FDA 483 - AlloSource - July 27, 2022

AlloSource, Inc. in Centennial, CO, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately document equipment calibration, specifically pull test results for tray sealers used in sterile packaging. Additionally, product labeling for ReConnex™ Pre-Sutured Tendon devices lacked a human-readable Unique Device Identifier (UDI) as required by regulations.