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

An FDA inspection of Smart Surgical, Inc. in Boise, ID, a biological drug manufacturer and tissue establishment, revealed significant deficiencies across its operations. The firm failed to ensure donor eligibility and proper screening for communicable diseases for its umbilical cord blood and amniotic membrane products. Additionally, critical issues were identified in sterility assurance, process validation, environmental monitoring, component testing, and complaint handling, indicating a systemic lack of control over manufacturing processes.