FDA 483 - Novus Surgical Solutions LLC - April 01, 2022

An FDA inspection of Novus Surgical Solutions LLC, a human tissue distributor in Allentown, PA, revealed significant deficiencies in its quality program. The firm failed to establish core Current Good Tissue Practice (CGTP) requirements, including quality audits, controlled storage areas, and procedures for product receipt and returns. Additionally, the firm lacked established procedures for equipment calibration.