FDA 483 - Smart Surgical, Inc - March 05, 2021

Smart Surgical, Inc. in Boise, ID, was inspected and received 11 observations primarily concerning deficiencies in donor eligibility screening for communicable diseases, inadequate aseptic processing controls, and a lack of validated manufacturing and testing processes for their umbilical cord blood and amniotic membrane products. The inspection revealed significant issues with quality control, environmental monitoring, and complaint handling procedures, indicating a systemic failure to ensure product sterility and donor safety.